In the News

NIH: Investigational COVID-19 Vaccine Well-Tolerated and Generates Immune Response in Older Adults

News Released September 29, 2020

A Phase 1 trial of an investigational mRNA vaccine to prevent SARS-CoV-2 infection has shown that the vaccine is well-tolerated and generates a strong immune response in older adults. A recent report published in the New England Journal of Medicine describes the findings from the study, which was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. SARS-CoV-2 is the virus that causes COVID-19 disease.

NIH: Fourth Large-Scale COVID-19 Vaccine Trial Begins in the United States

News Released September 23, 2020

A fourth Phase 3 clinical trial evaluating an investigational vaccine for coronavirus disease 2019 (COVID-19) has begun enrolling adult volunteers. The trial is designed to evaluate if the investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single dose regimen. Up to 60,000 volunteers will be enrolled in the trial at up to nearly 215 clinical research sites in the United States and internationally.

NIH Expands Clinical Trials to Test Convalescent Plasma Against COVID-19

News Released September 22, 2020

Two randomized, placebo-controlled clinical trials funded by the National Institutes of Health (NIH) are expanding enrollment to further evaluate convalescent plasma as a treatment for patients hospitalized with COVID-19. Preliminary observational studies indicate that convalescent plasma may improve outcomes among severely ill and hospitalized patients with COVID-19. Prospective, well-controlled randomized trials are needed to generate sufficient data on whether convalescent plasma is effective and safe for the treatment of COVID-19.

Eli Lilly and Company: Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalized Patients with COVID-19 in NIAID-Sponsored ACTT-2 Trial

News Released September 14, 2020

Eli Lilly and Company and Incyte announced initial data emerging from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). ACTT-2 included more than 1,000 patients and began on May 8 to assess the efficacy and safety of a 4-mg dose of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. Baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir.

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IDCRC Concept Quick Stats

ICP Status

Approved: 14
Administratively Not Supported: 15
Revise and Resubmit: 7
Withdrawn: 3
EWG Liaisons: 2
Not Approved: 20
Full EWG Review: 1
Resubmitted to ACTIV per DMID: 1

EWG Assignment

STI: 2
Respiratory: 7
Malaria/Tropical Diseases: 1
COVID: 55

ECP Status

Transitioned to IDCRC for Protocol Implementation: 4
In Protocol Development: 3
ECP Pending: 6
Hold: 2
Submitted to ACTIVE Mab Program per DMID: 1
Transitioned to Pediatric Working Group: 1
Transition to Phase III Vaccine Protocol Development: 1
Approved to move to CRS: 1
Merged into AIRS Protocol: 2
Under discussion with DMID/NIAID: 1

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