SARS-CoV-2

Design, setting, and population: Population-level surveillance of pregnant individuals infected with SARS-CoV-2 and their infants using the CANCOVID-Preg database between April 5, 2021 (beginning of the Delta variant time period and initiation of recommendations for vaccination in pregnancy in Canada), and December 31, 2022. Cases were identified based on COVID-19 diagnoses in pregnancy in 9 of 13 Canadian provinces/territories. Cases occurring through 2022 were followed up into 2023 for pregnancy conclusion and infant outcomes.

Exposure: SARS-CoV-2 infection in pregnancy, with or without prior vaccination.

Main outcomes and measures: COVID-19-associated hospitalization, critical care unit admission, and preterm birth.

Results: Of 26 584 cases identified, 19 899 cases were eligible for analysis. Among these, most infections occurred among those aged 30 to 35 years (46.3%) and among those of White race (55.9%). A total of 72% (n = 14 367) of cases were vaccinated and 28% (n = 5532) were unvaccinated prior to their COVID-19 diagnosis. Among those vaccinated prior to COVID-19 diagnosis, 80% (n = 11 425) were vaccinated prior to pregnancy and 20% (n = 2942) were vaccinated during pregnancy. Cases occurred during both Delta (n = 6120) and Omicron (n = 13 799) variant time periods. Vaccination was associated with lower risk of hospitalization (Delta: relative risk [RR], 0.38 [95% CI, 0.30-0.48]; absolute risk difference [ARD], 8.7% [95% CI, 7.3%-10.2%]; Omicron: RR, 0.38 [95% CI, 0.27-0.53]; ARD, 3.8% [95% CI, 2.4%-5.2%]), critical care unit admission (Delta: RR, 0.10 [95% CI, 0.04-0.26]; ARD, 2.4% [95% CI, 1.8%-2.9%]; Omicron: RR, 0.10 [95% CI, 0.03-0.29]; ARD, 0.85% [95% CI, 0.27%-1.44%]), and preterm birth (Delta: RR, 0.80 [95% CI, 0.66-0.98]; ARD, 1.8% [95% CI, 0.3%-3.4%]; Omicron: RR, 0.64 [95% CI, 0.52-0.77]; ARD, 4.1% [95% CI, 2.0%-6.2%]). In multivariable analyses, vaccination was still associated with lower hospitalization risk in both variant time periods after controlling for comorbid conditions. In Omicron, compared with the vaccinated group, those unvaccinated had an adjusted RR of hospitalization of 2.43 (95% CI, 1.72-3.43). In Delta, those unvaccinated had an adjusted RR of hospitalization of 3.82 (95% CI, 2.38-6.14).

Conclusions and relevance: Vaccination against SARS-CoV-2 prior to and during pregnancy, before COVID-19 diagnosis, was associated with a lower risk of severe maternal disease and preterm birth regardless of variant time period.

Author/s:

Sandra Blitz, Elisabeth McClymont, Lucia Forward

The 2024 National Academies of Sciences, Engineering, and Medicine Long COVID Definition: What Clinicians Need to Know

Megan George — Wed, 06 Aug 2025 22:16:16 +0000

Date Added:

August 6, 2025

Journal/Publication:

Journal of General Internal Medicine

Publication Date:

March 10, 2025

URL:

The 2024 National Academies of Sciences, Engineering, and Medicine Long COVID Definition: What Clinicians Need to Know

Type:

Public Health Announcements

Format:

Article

DOI (1):

10.1007/s11606-025-09415-8

Keywords

COVID-19

Long COVID

post-acute sequelae of COVID-19

PMID (1):

40063321

MeSH

COVID-19* / epidemiology

COVID-19* / complications

COVID-19* / diagnosis

COVID-19* / therapy

chronic disease

Humans

National Academies of Science

Engineering

and Medicine

U.S.

Health and Medicine Division*

post-acute COVID-19 syndrome

SARS-CoV-2

United States/epidemiology

A definition of long-COVID from the National Academy of Medicine. James W. Mold, MD, MPH

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Millions of Americans affected by Long COVID (LC) report difficulty accessing care and support. One barrier is obtaining a diagnosis. In response, US federal agencies commissioned a National Academies of Sciences, Engineering, and Medicine (NASEM) committee to re-examine the existing federal definitions for LC. The Committee concluded that LC is "an infection-associated chronic condition (IACC) occurring after SARS-CoV-2 infection that is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that can present as singular or multiple symptoms and/or diagnosable conditions." The full report was released in June 2024. We briefly highlight features and aspects of the definition that may help clinicians identify those who remain undiagnosed and improve care for all LC patients.

Author/s:

Lily Chu, Karyn Bishof, Abigail A Dumes, E Wesley Ely, Paule V Joseph, Andrea B Troxel

Personal protective effect of wearing surgical face masks in public spaces on self-reported respiratory symptoms in adults: pragmatic randomised superiority trial

Erin Blanchette — Mon, 26 Aug 2024 15:29:19 +0000

Date Added:

August 26, 2024

Journal/Publication:

BMJ

Publisher:

BMJ Publishing Group

Publication Date:

July 24, 2024

Volume:

386

Pages:

e078918

URL:

Personal protective effect of wearing surgical face masks in public spaces on self-reported respiratory symptoms in adults: pragmatic randomised superiority trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1136/bmj-2023-078918

Keywords

respiratory tract infections

PMID (1):

39048132

MeSH

Betacoronavirus

COVID-19

masks

respiratory tract infections

Coronavirus Infections

SARS-CoV-2

Advising high-risk patients to wear facial masks when out in public appears to make some sense. James W. Mold, MD, MPH

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Objective: To evaluate the personal protective effects of wearing versus not wearing surgical face masks in public spaces on self-reported respiratory symptoms over a 14 day period.

Design: Pragmatic randomised superiority trial.

Setting: Norway.

Participants: 4647 adults aged ≥18 years: 2371 were assigned to the intervention arm and 2276 to the control arm.

Interventions: Participants in the intervention arm were assigned to wear a surgical face mask in public spaces (eg, shopping centres, streets, public transport) over a 14 day period (mask wearing at home or work was not mentioned). Participants in the control arm were assigned to not wear a surgical face mask in public places.

Main outcome measures: The primary outcome was self-reported respiratory symptoms consistent with a respiratory infection. Secondary outcomes included self-reported and registered covid-19 infection.

Results: Between 10 February 2023 and 27 April 2023, 4647 participants were randomised of whom 4575 (2788 women (60.9%); mean age 51.0 (standard deviation 15.0) years) were included in the intention-to-treat analysis: 2313 (50.6%) in the intervention arm and 2262 (49.4%) in the control arm. 163 events (8.9%) of self-reported symptoms consistent with respiratory infection were reported in the intervention arm and 239 (12.2%) in the control arm. The marginal odds ratio was 0.71 (95% confidence interval (CI) 0.58 to 0.87; P=0.001) favouring the face mask intervention. The absolute risk difference was -3.2% (95% CI -5.2% to -1.3%; P<0.001). No statistically significant effect was found on self- reported (marginal odds ratio 1.07, 95% CI 0.58 to 1.98; P=0.82) or registered covid-19 infection (effect estimate and 95% CI not estimable owing to lack of events in the intervention arm).

Conclusion: Wearing a surgical face mask in public spaces over 14 days reduces the risk of self-reported symptoms consistent with a respiratory infection, compared with not wearing a surgical face mask.

Trial registration: ClinicalTrials.gov NCT05690516.

Author/s:

Runar Barstad Solberg, Atle Fretheim, Ingeborg Hess Elgersma, Mette Fagernes, Bjørn Gunnar Iversen, Lars G Hemkens, Christopher James Rose, Petter Elstrøm

Olgotrelvir as a Single-Agent Treatment of Nonhospitalized Patients with Covid-19

Alex Haga — Sun, 16 Jun 2024 18:56:52 +0000

Date Added:

June 16, 2024

Journal/Publication:

NEJM Evidence

Publication Date:

May 28, 2024

Issue:

Volume:

URL:

Olgotrelvir as a Single-Agent Treatment of Nonhospitalized Patients with Covid-19

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/EVIDoa2400026

Keywords

COVID-19

Antiviral

oral

PMID (1):

38804790

MeSH

COVID-19

COVID-19 Drug Treatment

SARS-CoV-2

Antiviral Agents* / administration & dosage

Antiviral Agents* / adverse effects

Antiviral Agents* / therapeutic use

Olgotrelvir (Ovydso) is an oral antiviral that can reduce the severity and duration of COVID-19 infections in outpatients. James W. Mold, MD, MPH

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Background: Olgotrelvir is an oral antiviral with dual mechanisms of action targeting severe acute respiratory syndrome coronavirus 2 main protease (i.e., Mpro) and human cathepsin L. It has potential to serve as a single-agent treatment of coronavirus disease 2019 (Covid-19).

Methods: We conducted a phase 3, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of olgotrelvir in 1212 nonhospitalized adult participants with mild to moderate Covid-19, irrespective of risk factors, who were randomly assigned to receive orally either 600 mg of olgotrelvir or placebo twice daily for 5 days. The primary and key secondary end points were time to sustained recovery of a panel of 11 Covid-19-related symptoms and the viral ribonucleic acid (RNA) load. The safety end point was incidence of treatment-emergent adverse events.

Results: The baseline characteristics of 1212 participants were similar in the two groups. In the modified intention-to-treat population (567 patients in the placebo group and 558 in the olgotrelvir group), the median time to symptom recovery was 205 hours in the olgotrelvir group versus 264 hours in the placebo group (hazard ratio, 1.29; 95% confidence interval [CI], 1.13 to 1.46; P<0.001). The least squares mean (95% CI) changes of viral RNA load from baseline were -2.20 (-2.59 to -1.81) log10 copies/ml in olgotrelvir-treated participants and -1.40 (-1.79 to -1.01) in participants receiving placebo at day 4. Skin rash (3.3%) and nausea (1.5%) were more frequent in the olgotrelvir group than in the placebo group; there were no treatment-related serious adverse events, and no deaths were reported.

Conclusions: Olgotrelvir as a single-agent treatment significantly improved symptom recovery. Adverse effects were not dose limiting. (Funded by Sorrento Therapeutics, a parent company of ACEA Therapeutics; ClinicalTrials.gov number, NCT05716425.).

Author/s:

Rongmeng Jiang, Bing Han, Wanhong Xu, Xiaoying Zhang, Chunxian Peng, Qiang Dang, Wei Sun, Ling Lin

Evaluation of Waning of SARS-CoV-2 Vaccine–Induced Immunity

Rowan Hutchins — Tue, 06 Jun 2023 05:00:00 +0000

Date Added:

June 6, 2023

Journal/Publication:

JAMA Netw Open

Publisher:

American Medical Association

Publication Date:

May 3, 2023

Issue:

Volume:

URL:

Evaluation of Waning of SARS-CoV-2 Vaccine–Induced Immunity

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jamanetworkopen.2023.10650

Keywords

COVID-19

COVID-19 vaccine

'Vaccination

PMID (1):

37133863

MeSH

SARS-CoV-2

COVID-19 Vaccines

COVID-19* / prevention & control

COVID-19* / epidemiology

It looks like the COVID vaccines protect about as long as flu vaccines, 6 months for primary immunization, 9 months for the booster. Sounds like we will be getting one each year. James W. Mold, MD, MPH

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Importance Estimates of the rate of waning of vaccine effectiveness (VE) against COVID-19 are key to assess population levels of protection and future needs for booster doses to face the resurgence of epidemic waves.

Objective To quantify the progressive waning of VE associated with the Delta and Omicron variants of SARS-CoV-2 by number of received doses.

Data Sources PubMed and Web of Science were searched from the databases’ inception to October 19, 2022, as well as reference lists of eligible articles. Preprints were included.

Study Selection Selected studies for this systematic review and meta-analysis were original articles reporting estimates of VE over time against laboratory-confirmed SARS-CoV-2 infection and symptomatic disease.

Data Extraction and Synthesis Estimates of VE at different time points from vaccination were retrieved from original studies. A secondary data analysis was performed to project VE at any time from last dose administration, improving the comparability across different studies and between the 2 considered variants. Pooled estimates were obtained from random-effects meta-analysis.

Main Outcomes and Measures Outcomes were VE against laboratory-confirmed Omicron or Delta infection and symptomatic disease and half-life and waning rate associated with vaccine-induced protection.

Results A total of 799 original articles and 149 reviews published in peer-reviewed journals and 35 preprints were identified. Of these, 40 studies were included in the analysis. Pooled estimates of VE of a primary vaccination cycle against laboratory-confirmed Omicron infection and symptomatic disease were both lower than 20% at 6 months from last dose administration. Booster doses restored VE to levels comparable to those acquired soon after the administration of the primary cycle. However, 9 months after booster administration, VE against Omicron was lower than 30% against laboratory-confirmed infection and symptomatic disease. The half-life of VE against symptomatic infection was estimated to be 87 days (95% CI, 67-129 days) for Omicron compared with 316 days (95% CI, 240-470 days) for Delta. Similar waning rates of VE were found for different age segments of the population.

Conclusions and Relevance These findings suggest that the effectiveness of COVID-19 vaccines against laboratory-confirmed Omicron or Delta infection and symptomatic disease rapidly wanes over time after the primary vaccination cycle and booster dose. These results can inform the design of appropriate targets and timing for future vaccination programs.

Author/s:

Menegale, Francesco, Manica, Mattia, Zardini, Agnese, Guzzetta, Giorgio, Marziano, Valentina, d'Andrea, Valeria, Trentini, Filippo, Ajelli, Marco, Poletti, Piero, Merler, Stefano

Dynamics of Naturally-Acquired Immunity Against SARS-CoV-2 in Children and Adolescents

Aubrey Delammermore — Sat, 04 Mar 2023 06:00:00 +0000

Date Added:

March 4, 2023

Journal/Publication:

The Journal of Pediatrics

Publisher:

Elsevier

Publication Date:

March 2, 2023

URL:

Dynamics of Naturally-Acquired Immunity Against SARS-CoV-2 in Children and Adolescents

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1016/j.jpeds.2023.02.016

Keywords

COVID-19

SARS-CoV-2

waning immunity

naturally aquired immunity

infection-induced immunity

MeSH

retrospective studies

Children and adolescents appear to develop long-lasting immunity after natural infection with COVID-19. James W. Mold, MD, MPH

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Background
To evaluate the duration of protection against reinfection conferred by a previous SARS-CoV-2 infection in children and adolescents.
Methods
We applied two complementary approaches: a matched test-negative, case-control design and a retrospective cohort design. 458,959 unvaccinated individuals aged 5-18 years were included. Analyses focused on July 1 to December 13, 2021, a period of Delta variant dominance in Israel. We evaluated three SARS-CoV-2-related outcomes: documented PCR confirmed infection or reinfection, symptomatic infection or reinfection, and SARS-CoV-2-related hospitalization or death.
Findings
Overall, children and adolescents who were previously infected acquired durable protection against reinfection with SARS-CoV-2 for at least 18 months. Importantly, no SARS-CoV-2-related deaths were recorded in either the SARS-CoV-2 naïve group or the previously infected group. Effectiveness of naturally-acquired immunity against a recurrent infection reached 89.2% (95% CI: 84.7%-92.4%) three to six months after first infection, mildly declining to 82.5% (95% CI, 79.1%-85.3%) 9-12 months after infection, with a slight non-significant waning trend up to 18 months after infection. Additionally, we found that ages 5-11 years exhibited no significant waning of naturally acquired protection throughout the outcome period, whereas waning protection in the 12-18 year-old age group was more prominent, but still mild.
Interpretation
Children and adolescents who were previously infected with SARS-CoV-2 remain protected to a high degree for 18 months. Further research is needed to examine naturally-acquired immunity against Omicron and newer emerging variants.

Author/s:

Patalon, T., Saciuk, Y., Perez, G., Peretz, A., Ben-Tov, A., Gazit, S.

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2022 Recommendations of the International Antiviral Society-USA Panel

Aubrey Delammermore — Sat, 07 Jan 2023 06:00:00 +0000

Date Added:

January 7, 2023

Journal/Publication:

JAMA

Publisher:

American Medical Association

Publication Date:

December 1, 2022

Issue:

Volume:

329

Pages:

63-84

URL:

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2022 Recommendations of the International Antiviral Society-USA Panel

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jama.2022.22246

Keywords

Antiviral Agents

Pharmaceutical Preparations

Anti-Retroviral Agents

HIV

Anti-HIV Agents

PMID (1):

36454551

MeSH

Anti-HIV Agents* / therapeutic use

Anti-Retroviral Agents / therapeutic use

HIV Infections* / drug therapy

Pharmaceutical Preparations

SARS-CoV-2

A summary of current recommendations regarding prevention and treatment of HIV infections with antiretrovirals. James W. Mold, MD, MPH

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Importance: Recent advances in treatment and prevention of HIV warrant updated recommendations to guide optimal practice.

Objective: Based on a critical evaluation of new data, to provide clinicians with recommendations on use of antiretroviral drugs for the treatment and prevention of HIV, laboratory monitoring, care of people aging with HIV, substance use disorder and HIV, and new challenges in people with HIV, including COVID-19 and monkeypox virus infection.

Evidence review: A panel of volunteer expert physician scientists were appointed to update the 2020 consensus recommendations. Relevant evidence in the literature (PubMed and Embase searches, which initially yielded 7891 unique citations, of which 834 were considered relevant) and studies presented at peer-reviewed scientific conferences between January 2020 and October 2022 were considered.

Findings: Initiation of antiretroviral therapy (ART) is recommended as soon as possible after diagnosis of HIV. Barriers to care should be addressed, including ensuring access to ART and adherence support. Integrase strand transfer inhibitor-containing regimens remain the mainstay of initial therapy. For people who have achieved viral suppression with a daily oral regimen, long-acting injectable therapy with cabotegravir plus rilpivirine given as infrequently as every 2 months is now an option. Weight gain and metabolic complications have been linked to certain antiretroviral medications; novel strategies to ameliorate these complications are needed. Management of comorbidities throughout the life span is increasingly important, because people with HIV are living longer and confronting the health challenges of aging. In addition, management of substance use disorder in people with HIV requires an evidence-based, integrated approach. Options for preexposure prophylaxis include oral medications (tenofovir disoproxil fumarate or tenofovir alafenamide plus emtricitabine) and, for the first time, a long-acting injectable agent, cabotegravir. Recent global health emergencies, like the SARS-CoV-2 pandemic and monkeypox virus outbreak, continue to have a major effect on people with HIV and the delivery of services. To address these and other challenges, an equity-based approach is essential.

Conclusions and relevance: Advances in treatment and prevention of HIV continue to improve outcomes, but challenges and opportunities remain.

Author/s:

Gandhi, R. T., Bedimo, R., Hoy, J. F.

Antibody Response Following SARS-CoV-2 Infection and Implications for Immunity: A Rapid Living Review

Aubrey Delammermore — Sat, 12 Nov 2022 06:00:00 +0000

Date Added:

November 12, 2022

Journal/Publication:

Agency for Healthcare Research and Quality

Publisher:

US Department of Health and Human Services

Publication Date:

March 15, 2021

Issue:

21-EHC016

URL:

Antibody Response Following SARS-CoV-2 Infection and Implications for Immunity: A Rapid Living Review

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.23970/AHRQEPCCOVIDIMMUNITY

Keywords

Health Services Research

PMID (1):

33784032

MeSH

Infection with the SARS-CoV-2 virus (COVID-19) induces substantial (around 90%) protection from reinfection for at least 6 months and probably longer. James W. Mold, MD, MPH

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The aims of this rapid systematic review are to synthesize evidence on the prevalence, levels, and durability of the antibody response to SARS-CoV-2 infection among adults and how antibodies correlate with protective immunity. Given the rapidly evolving evidence within this field, the Agency for Healthcare Research and Quality’s Evidence-based Practice Center (AHRQ EPC) Program will maintain this report as a living review with planned ongoing literature surveillance and critical appraisal. We will provide regular report updates as additional evidence becomes available, modifying the scope of the review as new directions in SARS-CoV-2 immunity research emerge. This review was conducted in coordination with the American College of Physicians (ACP) as part of AHRQ’s standing work to provide health professional organizations and systems with evidence reviews to support the development of clinical guidance for their clinician members.

Author/s:

Mackey, K., Arkhipova-Jenkins, I., Armstrong, C., Gean, E., Anderson, J., Paynter, R. A., Helfand, M.

Effect of fluvoxamine on outcomes of nonhospitalized patients with COVID-19: A systematic review and meta-analysis

Aubrey Delammermore — Sun, 06 Nov 2022 05:00:00 +0000

Date Added:

November 6, 2022

Journal/Publication:

Journal of Infection and Public Health

Publisher:

Elsevier B. V.

Publication Date:

October 13, 2022

Issue:

Volume:

Pages:

1259-1264

URL:

Effect of fluvoxamine on outcomes of nonhospitalized patients with COVID-19: A systematic review and meta-analysis

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1016/j.jiph.2022.10.010

Keywords

Odds Ratio

Artificial respiration

control groups

hospitalization

bibliometrics

PMID (1):

36272390

MeSH

Fluvoxamine can reduce risk of hospitalization in outpatients with COVID-19. James W. Mold, MD, MPH

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Objectives: This meta-analysis investigated the use of fluvoxamine for the treatment of nonhospitalized patients with COVID-19.

Methods: PubMed, Web of Science, Ovid medline, Embase, Scopus, Cochrane Library databases, and ClinicalTrials.gov were searched for studies published before June 25, 2022. Only clinical studies that compared the efficacy and safety of fluvoxamine with other alternatives or placebos in the treatment of nonhospitalized patients with COVID-19 were included.

Results: Four studies with 1814 patients, of whom 912 received fluvoxamine, were included in this study. Compared with the control group receiving placebo or no therapy, the study group receiving fluvoxamine demonstrated a lower risk of hospitalization and emergency department (ED) visits (odds ratio [OR], 0.59; 95 % CI, 0.44-0.79; I2 = 26 %). In addition, the rate of hospitalization remained significantly lower in patients who received fluvoxamine than in the control group (OR, 0.69; 95 % CI, 0.51-0.94; I2 = 36 %). Although the study group demonstrated a lower risk of requirement of mechanical ventilation and intensive care unit admission, and mortality than the control group, these differences were nonsignificant. Finally, fluvoxamine use was associated with a similar risk of adverse events as that observed in the control group.

Conclusion: Fluvoxamine can be safely used in nonhospitalized patients with COVID-19 and can reduce the hospitalization rate or ED visits in these patients.

Keywords: COVID-19; Emergency department; Fluvoxamine; Hospitalization; SARS-CoV-2.

Author/s:

Lu, L., Chao, C., Chang, S., Lan, S., Lai, C.

Care of Patients With New, Continuing, or Recurring Symptoms After Acute SARS-CoV-2 Infection

Saige Blanchard — Tue, 07 Jun 2022 05:00:00 +0000

Date Added:

June 7, 2022

Journal/Publication:

Annals of Internal Medicine

Publisher:

American College of Physicians

Publication Date:

May 27, 2022

URL:

Care of Patients With New, Continuing, or Recurring Symptoms After Acute SARS-CoV-2 Infection

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.7326/M22-1636

Keywords

PMID (1):

35622410

MeSH

post-acute COVID-19 syndrome

COVID-19

SARS-CoV-2

pandemics

National Institutes of Health (U.S.)

Guidance on how to evaluate and manage patients with prolonged COVID symptoms. James W. Mold, MD, MPH

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As the pandemic of acute SARS-CoV-2 infection continues, there is another pandemic that shadows it—the growing population of people who have new, continuing, or recurring symptoms long after initial infection. Many refer to this condition as “long COVID,” and the National Institutes of Health's (NIH) official name for the condition is postacute sequelae of SARS-CoV-2 (PASC). Whatever we call it, the current limited understanding of the pathophysiology, epidemiology, and course of this condition makes caring for these patients a vexing challenge.

Author/s:

Laine, C., Cotton, D.

Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients

Saige Blanchard — Mon, 03 Jan 2022 06:00:00 +0000

Date Added:

January 3, 2022

Journal/Publication:

New England Journal of Medicine

Publisher:

Massachusetts Medical Society

Publication Date:

December 16, 2021

URL:

Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa2116044

Keywords

Molnupiravir

Oral Treatment

COVID-19

Nonhospitalized Patients

PMID (1):

34914868

MeSH

Molnupiravir, when started within the first five days of clinical illness, reduced hospitalization rates for patients with SARS COV-2 from 9.7% to 6.8% and deaths from 2% to 0.2%. James W. Mold, MD, MPH

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Abstract
Background: New treatments are needed to reduce the risk of progression of coronavirus disease 2019 (Covid-19). Molnupiravir is an oral, small-molecule antiviral prodrug that is active against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Methods: We conducted a phase 3, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of treatment with molnupiravir started within 5 days after the onset of signs or symptoms in nonhospitalized, unvaccinated adults with mild-to-moderate, laboratory-confirmed Covid-19 and at least one risk factor for severe Covid-19 illness. Participants in the trial were randomly assigned to receive 800 mg of molnupiravir or placebo twice daily for 5 days. The primary efficacy end point was the incidence hospitalization or death at day 29; the incidence of adverse events was the primary safety end point. A planned interim analysis was performed when 50% of 1550 participants (target enrollment) had been followed through day 29.

Results: A total of 1433 participants underwent randomization; 716 were assigned to receive molnupiravir and 717 to receive placebo. With the exception of an imbalance in sex, baseline characteristics were similar in the two groups. The superiority of molnupiravir was demonstrated at the interim analysis; the risk of hospitalization for any cause or death through day 29 was lower with molnupiravir (28 of 385 participants [7.3%]) than with placebo (53 of 377 [14.1%]) (difference, -6.8 percentage points; 95% confidence interval, -11.3 to -2.4; P = 0.001). In the analysis of all participants who had undergone randomization, the percentage of participants who were hospitalized or died through day 29 was lower in the molnupiravir group than in the placebo group (6.8% [48 of 709] vs. 9.7% [68 of 699]; difference, -3.0 percentage points; 95% confidence interval, -5.9 to -0.1). Results of subgroup analyses were largely consistent with these overall results; in some subgroups, such as patients with evidence of previous SARS-CoV-2 infection, those with low baseline viral load, and those with diabetes, the point estimate for the difference favored placebo. One death was reported in the molnupiravir group and 9 were reported in the placebo group through day 29. Adverse events were reported in 216 of 710 participants (30.4%) in the molnupiravir group and 231 of 701 (33.0%) in the placebo group.

Conclusions: Early treatment with molnupiravir reduced the risk of hospitalization or death in at-risk, unvaccinated adults with Covid-19. (Funded by Merck Sharp and Dohme; MOVe-OUT ClinicalTrials.gov number, NCT04575597.).

Author/s:

Bernal, A. J., Gomes da Silva, M., Musungaie, D., Kovalchuk, E., Gonzalez, A., Delos Reyes, V., Martin-Quiros, A., Caraco, Y., Williams-Diaz, A., Brown, M., Du, J., Pedley, A., Assaid, C., Strizki, J., Grobler, J., Shamsuddin, H., Tipping, R., Wan, H., Paschke, A., Butterton, J., Johnson, M., De Anda, C., MOVe-OUT Study Group

COVID-19 and Pregnancy

Saige Blanchard — Mon, 03 Jan 2022 06:00:00 +0000

Date Added:

January 3, 2022

Journal/Publication:

Journal of the American Medical Association

Publisher:

American Medical Association

Publication Date:

December 10, 2021

URL:

COVID-19 and Pregnancy

Type:

Patient Education Materials

Format:

Article

DOI (1):

10.1001/jama.2021.22679

Keywords

Pregnancy

COVID-19

Center for Disease Control

MeSH

A summary for patients of the recommendations and consequences of COVID-19 vaccination during pregnancy. James W. Mold, MD, MPH

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Pregnant and recently pregnant individuals who become infected with the COVID-19 virus
are at high risk of requiring extra medical care.
According to the Centers for Disease Control and Prevention (CDC),
between January 22, 2020, and November 29, 2021, 148 327
pregnant individuals had documented infection with SARS-CoV-2
(the virus that causes COVID-19) and 241 had died of COVID-19.
Of the 121 973 pregnant people with information on hospitalization
available, 20.6% were hospitalized with COVID-19 or pregnancyrelated conditions.

Author/s:

Walter, K.

Infectious Diseases Society of America Guidelines on Infection Prevention for Healthcare Personnel Caring for Patients with Suspected or Known COVID-19

Bethie Seay — Tue, 30 Nov 2021 06:00:00 +0000

Date Added:

November 30, 2021

Journal/Publication:

Clinical Infectious Diseases

Publication Date:

November 15, 2021

Type:

Meta-analyses, Reviews, and Guidelines

DOI (1):

10.1093/cid/ciab953

PMID (1):

34791102

Recommendations from the Infectious Disease Society of America regarding prevention of COVID-19 infection in health care professionals.

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Background: Since its emergence in late 2019, SARS-CoV-2 continues to pose a risk to healthcare personnel (HCP) and patients in healthcare settings. Although all clinical interactions likely carry some risk of transmission, human actions like coughing and care activities like aerosol-generating procedures likely have a higher risk of transmission. The rapid emergence and global spread of SARS-CoV-2 continues to create significant challenges in healthcare facilities, particularly with shortages of personal protective equipment (PPE) used by HCP. Evidence-based recommendations for what PPE to use in conventional, contingency, and crisis standards of care continue to be needed. Where evidence is lacking, the development of specific research questions can help direct funders and investigators.

Objective: Develop evidence-based rapid guidelines intended to support HCP in their decisions about infection prevention when caring for patients with suspected or known COVID-19.

Methods: IDSA formed a multidisciplinary guideline panel including frontline clinicians, infectious disease specialists, experts in infection control, and guideline methodologists with representation from the disciplines of public health, medical microbiology, pediatrics, critical care medicine and gastroenterology. The process followed a rapid recommendation checklist. The panel prioritized questions and outcomes. Then a systematic review of the peer-reviewed and grey literature was conducted. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence and make recommendations.

Results: The IDSA guideline panel agreed on eight recommendations, including two updated recommendations and one new recommendation added since the first version of the guideline. Narrative summaries of other interventions undergoing evaluations are also included.

Conclusions: Using a combination of direct and indirect evidence, the panel was able to provide recommendations for eight specific questions on the use of PPE for HCP providing care for patients with suspected or known COVID-19. Where evidence was lacking, attempts were made to provide potential avenues for investigation. There remain significant gaps in the understanding of the transmission dynamics of SARS-CoV-2 and PPE recommendations may need to be modified in response to new evidence. These recommendations should serve as a minimum for PPE use in healthcare facilities and do not preclude decisions based on local risk assessments or requirements of local health jurisdictions or other regulatory bodies.

Author/s:

Lynch, J. B., Davitkov, P., Anderson, D. J., Bhimraj, A., Cheng, V. C. C., Guzman-Cottrill, J., Dhindsa, J., Duggal, A., Jain, M. K., Lee, G. M., Liang, S. Y., McGeer, A., Varghese, J., Lavergne, V., Murad, M. H., Mustafa, R. A., Sultan, S., Falck-Ytter, Y., Morgan, R. L.

Short-term and Long-term Rates of Postacute Sequelae of SARS-CoV-2 Infection: A Systematic Review

Bethie Seay — Sun, 07 Nov 2021 05:00:00 +0000

Date Added:

November 7, 2021

Journal/Publication:

JAMA Network Open

Publication Date:

October 13, 2021

Issue:

Volume:

Pages:

e2128568

Type:

Meta-analyses, Reviews, and Guidelines

DOI (1):

10.1001/jamanetworkopen.2021.28568

A summary of post-COVID symptoms and their duration based upon studies involving more than 250,000 cases.

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Importance
Short-term and long-term persistent postacute sequelae of COVID-19 (PASC) have not been systematically evaluated. The incidence and evolution of PASC are dependent on time from infection, organ systems and tissue affected, vaccination status, variant of the virus, and geographic region.

Objective
To estimate organ system–specific frequency and evolution of PASC.

Evidence Review
PubMed (MEDLINE), Scopus, the World Health Organization Global Literature on Coronavirus Disease, and CoronaCentral databases were searched from December 2019 through March 2021. A total of 2100 studies were identified from databases and through cited references. Studies providing data on PASC in children and adults were included. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines for abstracting data were followed and performed independently by 2 reviewers. Quality was assessed using the Newcastle-Ottawa Scale for cohort studies. The main outcome was frequency of PASC diagnosed by (1) laboratory investigation, (2) radiologic pathology, and (3) clinical signs and symptoms. PASC were classified by organ system, ie, neurologic; cardiovascular; respiratory; digestive; dermatologic; and ear, nose, and throat as well as mental health, constitutional symptoms, and functional mobility.

Findings
From a total of 2100 studies identified, 57 studies with 250 351 survivors of COVID-19 met inclusion criteria. The mean (SD) age of survivors was 54.4 (8.9) years, 140 196 (56%) were male, and 197 777 (79%) were hospitalized during acute COVID-19. High-income countries contributed 45 studies (79%). The median (IQR) proportion of COVID-19 survivors experiencing at least 1 PASC was 54.0% (45.0%-69.0%; 13 studies) at 1 month (short-term), 55.0% (34.8%-65.5%; 38 studies) at 2 to 5 months (intermediate-term), and 54.0% (31.0%-67.0%; 9 studies) at 6 or more months (long-term). Most prevalent pulmonary sequelae, neurologic disorders, mental health disorders, functional mobility impairments, and general and constitutional symptoms were chest imaging abnormality (median [IQR], 62.2% [45.8%-76.5%]), difficulty concentrating (median [IQR], 23.8% [20.4%-25.9%]), generalized anxiety disorder (median [IQR], 29.6% [14.0%-44.0%]), general functional impairments (median [IQR], 44.0% [23.4%-62.6%]), and fatigue or muscle weakness (median [IQR], 37.5% [25.4%-54.5%]), respectively. Other frequently reported symptoms included cardiac, dermatologic, digestive, and ear, nose, and throat disorders.

Conclusions and Relevance
In this systematic review, more than half of COVID-19 survivors experienced PASC 6 months after recovery. The most common PASC involved functional mobility impairments, pulmonary abnormalities, and mental health disorders. These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries.

Author/s:

Groff, D., Sun, A., Ssentongo, A. E., Ba, D. M., Parsons, N., Poudel, G. R., Lekoubou, A., Oh, J. S., Ericson, J. E., Ssentongo, P., Chinchilli, V. M.

Incidence, co-occurrence, and evolution of long-COVID features: A 6-month retrospective cohort study of 273,618 survivors of COVID-19

Bethie Seay — Tue, 05 Oct 2021 05:00:00 +0000

Date Added:

October 5, 2021

Journal/Publication:

PLOS Medicine

Publication Date:

September 28, 2021

Issue:

Volume:

Type:

Clinical Research Results

DOI (1):

10.1371/journal.pmed.1003773

An assessment of the epidemiology and characteristics of long COVID syndrome from nearly 275,000 linked electronic records.

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Background
Long-COVID refers to a variety of symptoms affecting different organs reported by people following Coronavirus Disease 2019 (COVID-19) infection. To date, there have been no robust estimates of the incidence and co-occurrence of long-COVID features, their relationship to age, sex, or severity of infection, and the extent to which they are specific to COVID-19. The aim of this study is to address these issues.

Methods and findings
We conducted a retrospective cohort study based on linked electronic health records (EHRs) data from 81 million patients including 273,618 COVID-19 survivors. The incidence and co-occurrence within 6 months and in the 3 to 6 months after COVID-19 diagnosis were calculated for 9 core features of long-COVID (breathing difficulties/breathlessness, fatigue/malaise, chest/throat pain, headache, abdominal symptoms, myalgia, other pain, cognitive symptoms, and anxiety/depression). Their co-occurrence network was also analyzed. Comparison with a propensity score–matched cohort of patients diagnosed with influenza during the same time period was achieved using Kaplan–Meier analysis and the Cox proportional hazard model. The incidence of atopic dermatitis was used as a negative control.

Among COVID-19 survivors (mean [SD] age: 46.3 [19.8], 55.6% female), 57.00% had one or more long-COVID feature recorded during the whole 6-month period (i.e., including the acute phase), and 36.55% between 3 and 6 months. The incidence of each feature was: abnormal breathing (18.71% in the 1- to 180-day period; 7.94% in the 90- to180-day period), fatigue/malaise (12.82%; 5.87%), chest/throat pain (12.60%; 5.71%), headache (8.67%; 4.63%), other pain (11.60%; 7.19%), abdominal symptoms (15.58%; 8.29%), myalgia (3.24%; 1.54%), cognitive symptoms (7.88%; 3.95%), and anxiety/depression (22.82%; 15.49%). All 9 features were more frequently reported after COVID-19 than after influenza (with an overall excess incidence of 16.60% and hazard ratios between 1.44 and 2.04, all p < 0.001), co-occurred more commonly, and formed a more interconnected network. Significant differences in incidence and co-occurrence were associated with sex, age, and illness severity. Besides the limitations inherent to EHR data, limitations of this study include that (i) the findings do not generalize to patients who have had COVID-19 but were not diagnosed, nor to patients who do not seek or receive medical attention when experiencing symptoms of long-COVID; (ii) the findings say nothing about the persistence of the clinical features; and (iii) the difference between cohorts might be affected by one cohort seeking or receiving more medical attention for their symptoms.

Conclusions
Long-COVID clinical features occurred and co-occurred frequently and showed some specificity to COVID-19, though they were also observed after influenza. Different long-COVID clinical profiles were observed based on demographics and illness severity.

Author summary
Why was this study done?
Long-COVID has been described in recent studies. But we do not know the risk of developing features of this condition and how it is affected by factors such as age, sex, or severity of infection.
We do not know if the risk of having features of long-COVID is more likely after Coronavirus Disease 2019 (COVID-19) than after influenza.
We do not know about the extent to which different features of long-COVID co-occur.
What did the researchers do and find?
This research used data from electronic health records of 273,618 patients diagnosed with COVID-19 and estimated the risk of having long-COVID features in the 6 months after a diagnosis of COVID-19. It compared the risk of long-COVID features in different groups within the population and also compared the risk to that after influenza.
The research found that over 1 in 3 patients had one or more features of long-COVID recorded between 3 and 6 months after a diagnosis of COVID-19. This was significantly higher than after influenza.
For 2 in 5 of the patients who had long-COVID features in the 3- to 6-month period, they had no record of any such feature in the previous 3 months.
The risk of long-COVID features was higher in patients who had more severe COVID-19 illness, and slightly higher among females and young adults. White and non-white patients were equally affected.
What do these findings mean?
Knowing the risk of long-COVID features helps in planning the relevant healthcare service provision.
The fact that the risk is higher after COVID-19 than after influenza suggests that their origin might, in part, directly involve infection with SARS-CoV-2 and is not just a general consequence of viral infection. This might help in developing effective treatments against long-COVID.
The findings in the subgroups, and the fact that the majority of patients who have features of long-COVID in the 3- to 6-month period already had symptoms in the first 3 months, may help in identifying those at greatest risk.

Author/s:

Taquet, M., Dercon, Q., Luciano, S., Geddes, J. R., Husain, M., Harrison, P. J.