COVID-19

October 15, 2021: The Impact of Community Masking on COVID-19: A Cluster-Randomized Trial in Bangladesh (Jason Abaluck, PhD)

Posted on by terren.green@duke.edu

Speaker

Jason Abaluck, PhD
Professor of Economics
Yale School of Management

Topic

The Impact of Community Masking on COVID-19: A Cluster-Randomized Trial in Bangladesh

Keywords

COVID-19; Cluster-randomized trial; Masking; Community spread; NORM model

Key Points

  • Dr. Abaluck’s cluster-randomized trial on the impact of community masking in ~350,000 adults in 600 villages of Bangledesh aimed to answer 2 questions: What strategies or interventions will increase mask-wearing? and What is the impact of mask wearing intervention on COVID-10?
  • There are two major differences between the existing randomized trials of mask wearing for flu and the impact of community masking in Bangladesh trial. The first issue is the existing trials were randomized individually not by communities so you cannot evaluate weather masks act as source control. The second issue with the existing trials is the discrepancy between the number of people who attest to wearing a mask and the number who actually wore a mask.
  • The impact of community masking in Bangladesh trial used the NORM model to increase mask wearing. The NORM model distributes masks at No-cost, Offers information about why mask wearing is important, Reinforces mask wearing by having mask promoters give free masks and information in public places, and Modeling by trusted community leaders wearing masks and endorsing mask wearing.
  • The NORM model more than tripled mask usage(13% usage increased to 42%), increased physical distancing, and had a sustained impact that lasted at least 10 weeks.
  • Communities where the NORM model was employed saw a 9% reduction in symptomatic COVID-19 infections.
  • Mask wearing showed a greater reduction in COVID-19 among the elderly.

Discussion Themes

The NORM model would have different efficacy rates in different cultures and communities.

You can get some people to wear a mask by just distributing the masks in public places and asking them to wear them.

Masks are not an all-or-nothing protection. Masks have a dose-reduction effect and that dose-reduction translates into a transmission effect.

 

Read more about the Dr. Abaluck’s work on masking and COVID-19 in the recently published Discussion Paper.

Tags

#pctGR, @Collaboratory1, @Jabaluck

October 13, 2021: COVID-19 Grand Rounds to Feature Cluster Randomized Trial of Community Masking

Posted on by Damon Seils
Headshot of Jason Abaluck
Dr. Jason Abaluck

In this Friday’s COVID-19 Grand Rounds session, Dr. Jason Abaluck of Yale University will present “The Impact of Community Masking on COVID-19: A Cluster-Randomized Trial in Bangladesh.”

The Grand Rounds session will be held on Friday, October 15, at 1:00 pm eastern. Join the online meeting.

The NIH Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.

For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

October 1, 2021: COVID-OUT: From Computer Modeling to a Phase III Trial of Early Outpatient Treatment for SARS-CoV-2 Infection (Carolyn Bramante, MD, MPH; Thomas Murray, PhD; Jared Huling, PhD)

Posted on by terren.green@duke.edu

Speakers

Carolyn Bramante, MD, MPH
Division of General Internal Medicine
Departments of Internal Medicine and Pediatrics
Core faculty in the Program in Health Disparities Research and the Center for Pediatric Obesity Medicine
University of Minnesota Medical School

Thomas Murray, PhD
Division of Biostatistics
Coordinating Centers for Biometric Research
School of Public Health
University of Minnesota

Jared Huling, PhD
Division of Biostatistics
School of Public Health
University of Minnesota

Topic

COVID-OUT: From Computer Modeling to a Phase III Trial of Early Outpatient Treatment for SARS-CoV-2 Infection

Keywords

COVID-OUT; Study design; Randomized controlled trial; Metformin; Parallel enrollment design; De-centralized study; Nested SMART study

Key Points

  • The COVID-OUT trial is a phase 3, double-blinded, matched placebo-controlled, factorial design study of early outpatient treatments for SARS-Co-V-2 infection.
  • Metformin has a history of antiviral properties and has been shown, pre-COVID-19, to lower inflammation in the body, inhibit mTOR action, and cytokine-reducing effects.
  • Metformin is safe, inexpensive, and widely available.
  • The COVID-OUT trial aims to test 1,124 subjects in a 6 arm study design with metformin alone, ivermectin alone, fluvoxamine alone, metformin and fluvoxamine combined, metformin and ivermectin combined, and placebo.
  • A parallel enrollment design is used with a nested SMART study prevention trial.
  • COVID-OUT uses pre-packaged pill boxes to deliver meds to participants at 7 sites in order to encourage the correct dosage for each drug.

Discussion Themes

De-centralized clinical trials take a lot of training for participating sites. You could potentially do more with a larger central site and more limited involvement of the de-centralized sites.

Randomization strategies can be challenging in de-centralized trials.

Platform factorial design with multiple agents of interest presents a challenge for statistical analysis.

 

Read more about the COVID-OUT trial.

Tags

#pctGR, @Collaboratory1

September 29, 2021: COVID-19 Grand Rounds to Feature COVID-OUT Trial of Outpatient Treatments

Posted on by Damon Seils
Headshots of Drs. Carolyn Bramante, Thomas Murray, Jared Huling
Left to right: Dr. Carolyn Bramante, Dr. Thomas Murray, and Dr. Jared Huling

In this Friday’s COVID-19 Grand Rounds session, Dr. Carolyn Bramante, Dr. Thomas Murray, and Dr. Jared Huling of the University of Minnesota will present “COVID-OUT: From Computer Modeling to a Phase III Trial of Early Outpatient Treatment for SARS-CoV-2 Infection.” COVID-OUT is a factorial randomized clinical trial of metformin, ivermectin, fluvoxamine, or a combination of these medications among outpatients with symptoms of COVID-19 or long COVID.

The Grand Rounds session will be held on Friday, October 1, at 1:00 pm eastern. Join the online meeting.

The NIH Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.

For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

Grand Rounds October 1: COVID-OUT: From Computer Modeling to a Phase III Trial of Early Outpatient Treatment for SARS-CoV-2 Infection

Speakers:
Carolyn Bramante, MD, MPH
Division of General Internal Medicine
Departments of Internal Medicine and Pediatrics
Core faculty in the Program in Health Disparities Research and the Center for Pediatric Obesity Medicine
University of Minnesota Medical School

Thomas Murray, PhD
Division of Biostatistics
Coordinating Centers for Biometric Research
School of Public Health
University of Minnesota

Jared Huling, PhD
Division of Biostatistics
School of Public Health
University of Minnesota

Topic: COVID-OUT: From Computer Modeling to a Phase III Trial of Early Outpatient Treatment for SARS-CoV-2 Infection

Date: Friday, October 1, 2021, 1:00-2:00 p.m. ET

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August 20, 2021: Fluvoxamine for Early Treatment of COVID-19: The STOP COVID Clinical Trials (Eric Lenze, MD)

Posted on by terren.green@duke.edu

Speaker

Eric Lenze, MD
Wallace and Lucille K. Renard Professor of Psychiatry & Anesthesiology
Washington University School of Medicine, St. Louis

Topic

Fluvoxamine for Early Treatment of COVID-19: The STOP COVID Clinical Trials

Keywords

COVID-19 treatment; STOP COVID; Fluvoxamine; Repurposed therapy; Decentralized clinical trial

Key Points

  • While using Fluvoxamine to treat anxiety in patients with Wolfram Syndrome, Dr. Reiersen from Washington University, St. Louis learned that Fluvoxamine reduced inflammation and interfered with viral function.
  • Dr. Lenze, Dr. Reiersen, and Dr. Mattar began the preliminary pragmatic, non-contact, but high-touch STOP COVID trial in April 2020.
  • Results from the preliminary study showed that 0% of patients experienced clinical deterioration in the Fluvoxamine group while 8.3% of patients in the placebo group deteriorated.
  • The STOP-COVID 2 study was a decentralized, hub-and-spoke clinical trial conducted across the US and 2 provinces of Canada.
  • The Data Safety Monitoring Board(DSMB) for the study recommended an early stop for futility due to a low case rate and difficulty recruiting patients.

Discussion Themes

What outcome variables should we be using in COVID-19 studies? A binary outcome measure may limit the power of the study. When possible, continuous outcomes provide more statistical power and come closer to representing real-life outcomes.

What role should primary care providers play in clinical studies?

Read more about Dr. Lenze’s work with the STOP COVID trials.

Tags

#pctGR, @Collaboratory1

August 17, 2021: COVID-19 Grand Rounds Continues With Fluvoxamine and the STOP COVID Trials

Posted on by Damon Seils

Dr. Eric Lenze
Dr. Eric Lenze

In this Friday’s COVID-19 Grand Rounds session, Dr. Eric Lenze of the Washington University School of Medicine will present “Fluvoxamine for Early Treatment of COVID-19: the STOP COVID Clinical Trials.”

The Grand Rounds session will be held on Friday, August 20, at 1:00 pm eastern. Join the online meeting.

The NIH Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.

For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

August 17, 2021: Grand Rounds Podcast with Survivor Corps Now Available

Posted on by Gina Uhlenbrauck

Survivor Corp logoIn the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez interviews Diana Berrent, JD, founder of Survivor Corps, Nick Guthe, Survivor Corps member and advisor, and Natalie Lambert, PhD, of the Indiana University School of Medicine, around best practices for medical professionals treating patients experiencing the debilitating effects of long-term COVID-19.

The full July 23 Grand Rounds webinar is also available.

August 13, 2021: Got anything for this cough? Outpatient Treatment Trials in the Time of COVID (Davey Smith MD)

Posted on by terren.green@duke.edu

Speaker

Davey Smith, MD
Protocol Co-Chair ACTIV-2
Professor of Medicine, UC San Diego

Topic

Got anything for this cough? Outpatient Treatment Trials in the Time of COVID

Keywords

COVID-19 treatment; Adaptive Platform Trial; ACTIV-2 Trial; Antiviral therapy

Key Points

  • An Adaptive Platform Trial is a trial in which multiple drugs can be tested at the same time to increase efficiency and transition seamlessly from a Phase II to a Phase III trial.

  • An interim analysis determines if a drug is moved on to trial Phase III.

  • The trials adapt as researchers learn more about COVID-19 and potential treatments.

  • Monoclonal antibody therapies showed promise initially, but COVID-19 variants have lessened their efficacy.

Discussion Themes

The ACTIV-2 trial initially focused on using antivirals, specifically monoclonal antibodies, to achieve a reduced viral load as an endpoint measure.  Changes were made to this endpoint measure as it became clear that the FDA would issue an Emergency Use Authorization only for a decrease in hospitalization and death.  

To adjust to the rapidly changing COVID-19 landscape of changing therapeutics, vaccines, and variants, the ACTIV-2 team remained nimble and flexible with the ability to act quickly when presented with new situations and information.  

Read more about the Active-2 Trial.

Tags

#pctGR, @Collaboratory1, @DaveySmithMD

Podcast August 5, 2021: Survivor Corps: Long-Term COVID-19 Patient Engagement (Diana Berrent, JD; Natalie Lambert, PhD; Nick Guthe)

Posted on by Gina Uhlenbrauck

This podcast continues the discussion with Diana Berrent, JD, and Nick Guthe, both of Survivor Corps, and Natalie Lambert, PhD, of the Indiana University School of Medicine, as they describe best practices for medical professionals treating patients experiencing debilitating effects of COVID-19.

Click on the recording below to listen to the podcast.

Want to hear more? View the full Grand Rounds presentation.

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Read the transcript.