CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,753 enrolled
Drug / intervention
LY3819253 +7 morebiological
Likely dose
PF-07304814 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04501978
NCT04501978Phase 3Completed
CompareCT.gov

A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 6, 2020·Updated Aug 25, 2023

In Brief

A Phase 3 clinical trial evaluating LY3819253, Placebo, and 6 other interventions for Covid19. Completed, enrolled 2,753 participants across 135 sites in 10 countries.

Detailed Summary

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesDenmark, Greece, Nigeria, Poland, Singapore, Spain, Switzerland, Uganda, United Kingdom, United States
CollaboratorsInternational Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Eli Lilly and Company, Vir Biotechnology, Inc., GlaxoSmithKline, Brii Biosciences Limited, AstraZeneca, Molecular Partners AG, Pfizer, University of Minnesota

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedAug 6, 2020
Enrollment StartAug 4, 2020
Primary CompletionApr 6, 2022
Study CompletionJul 14, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.9 years ago

Interventions

LY3819253biological

Participants are no longer being randomized to this intervention.

Placebodrug

Commercially available 0.9% sodium chloride solution. Administered by IV infusion

Remdesivirbiological

Provided to all study participants as SOC unless contraindicated for an individual patient.

VIR-7831biological

Participants are no longer being randomized to this intervention.

BRII-196/BRII-198biological

Participants are no longer being randomized to this intervention.

AZD7442biological

Participants are no longer being randomized to this intervention.

MP0420drug

Participants are no longer being randomized to this intervention.

PF-07304814drug

250 mg per day for 5 days. Administered as a constant rate intravenous infusion. Suspended: Participants are not currently being randomized to this intervention.