CD12_COVID-19 [COVID-19]
Research type
Research Study
Full title
A Phase 2b/3, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of Leronlimab for Patients with Severe or Critical Coronavirus Disease 2019 (COVID-19)
IRAS ID
284051
Contact name
Sanjay Bhagani
Contact email
Sponsor organisation
CytoDyn, Inc.
Eudract number
2020-001996-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 22 days
Research summary
This study is designed to evaluate the potential ability of the study drug leronlimab to reduce mortality and improve the clinical condition of COVID-19 patients. We believe Leronlimab will achieve this in three ways. \n\nFirstly by improving a condition known as Acute Respiratory Distress Syndrome. When a patient has Acute Respiratory Distress Syndrome, fluid builds up in their lungs and their body can’t get the oxygen it needs. Secondly we believe that Leronlimab will help to fight COVID-19 by boosting the body’s immune response to the virus. Thirdly there is evidence that leronlimab will reduce the amount of virus (know as the viral load) in patients’ bodies. \n\nThis study is ready to start immediately. It builds upon prior and ongoing clinical experience with Leronlimab mostly as a treatment for HIV. More than 750 patients and healthy volunteers have been treated demonstrating a good safety profile. The study allows for prior or concurrent treatment with anti-inflammatory or anti- viral agents.\n\n
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
20/YH/0172
Date of REC Opinion
26 Aug 2020
REC opinion
Further Information Favourable Opinion