This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 75 sites globally.
The study will compare different investigational therapeutic agents to a control arm.
Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 440 participants
Primary Purpose: Treatment
Actual Study Start Date: February 21, 2020
Estimated Study Completion Date: April 1, 2023
- Admitted to a hospital with symptoms suggestive of COVID-19 infection.
- Male or non-pregnant female adult > / = 18 years of age at time of enrollment.
- Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen collected < 72 hours prior to randomization.
- Alanine Transaminase (ALT)/Aspartate Transaminase (AST) > 5 times the upper limit of normal.
- Estimated glomerular filtration rate (eGFR) < 50 or requiring dialysis.
- Pregnancy or breast feeding.
There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s).
For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you'll be connected to the team.