In the News

NIH: Phase 3 Clinical Trial of Investigational Vaccine for COVID-19 Begins

News Released July 27, 2020

A Phase 3 clinical trial designed to evaluate if an investigational vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19) in adults has begun. The vaccine, known as mRNA-1273, was co-developed by the Cambridge, Massachusetts-based biotechnology company Moderna, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial, which will be conducted at U.S. clinical research sites, is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19.

Read more on the NIH website.

Participating IDCRC Sites

EurekAlert: COVID-19 Prevention Network Launches Two Research Studies Evaluating Monoclonal Antibodies

News Released August 10, 2020

The COVID-19 Prevention Network (CoVPN) today announced two Phase 3 trials to determine whether monoclonal antibodies (mAbs) can prevent SARS-CoV-2, the virus that causes COVID-19. The first trial, CoVPN 3501, will evaluate LY-CoV555, an Eli Lilly and Company mAb to see whether it can prevent SARS-CoV-2 infection among people living or working in skilled nursing and assisted living facilities. Scientists from the National Institute of Allergy and Infectious Diseases Vaccine Research Center and Abcellera Biologics discovered LY-CoV555. The trial will enroll up to 2,400 participants in the U.S. who will be randomized to receive an intravenous infusion of LY-CoV555 or a placebo. The second trial, CoVPN 3502, will evaluate REGN-COV-2, a Regeneron Pharmaceutical double mAb combination, to see if it will prevent infection among household contacts with close exposure to someone recently diagnosed with COVID-19 that has been sustained for at least 48 hours. The study will enroll approximately 2,000 participants in the U.S.

Read more on the EurekAlert! website. 

Participating IDCRC Sites

 NIH Clinical Trial Testing Remdesivir Plus Interferon Beta-1a for COVID-19 Treatment Begins

News Released August 5, 2020

A randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen consisting of the antiviral remdesivir plus the immunomodulator interferon beta-1a in patients with coronavirus disease 2019 (COVID-19) has begun. The study, called the Adaptive COVID-19 Treatment Trial 3 (ACTT 3), is anticipated to enroll more than 1,000 hospitalized adults with COVID-19 at as many as 100 sites in the United States and abroad. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the trial.

Read more on the NIH website. 

Participating IDCRC Sites

Publications

View recent journal articles featuring IDCRC-supported work below:

• An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
• Remdesivir for the Treatment of Covid-19 — Preliminary Report

Manual of Procedures Sections

View the first two approved IDCRC Manual of Procedures (MOP) sections which describe structure, operating policies, roles and responsibilities of entities and individuals within the unit/consortium:

• Manual of Procedures – Expert Working Groups
• Manual of Procedures – Concept Review, Development and Modifications

Organizational Charts

View the approved IDCRC organizational charts for our six Expert Working Groups and seven Key Function Committees:

• Expert Working Groups
• Key Function Committees

Communications Resources

Please click the links below to access IDCRC communications resources on Box or visit the web-based toolkit.

• IDCRC Logos
• IDCRC Listservs
• IDCRC Letterhead
• Email Signature Guidance
• Communications Plan: Year 1
• Publications Guidance
• Standard PowerPoint Template
• Meeting Agenda Template
• Boiler Plate Language for Media Materials

IDCRC Concept Quick Stats