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R10933-10987-COV-2066


Title A Master Protocol Assessing The Safety, Tolerability, And Efficacy Of Anti-Spike (S) Sars-Cov-2 Monoclonal Antibodies For The Treatment Of Hospitalized Patients With Covid-19
Therapeutic Area Covid-19
Principal Investigator Brian Chow, MD
Min Age 18 Years
Gender Any
Contact Vidya Iyer
617-636-0186
viyer1@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04426695

Overview

This is a study being conducted in patients hospitalized with COVID-19. The study is looking to assess the experimenatal drugs REGN10933 and REGN10987 to see how if the drug is safe and how well it is tolerated. The study drug will be given as a one time infusion through your veins and multiple samples will be collected throughout the study duration (upto 25 weeks) to check the level of drug in the body. You have a 1 in 3 chance of receiving REGN10933 + REGN10987 at a lower dose, a one-in-three chance of receiving REGN10933 + REGN10987 at a higher dose, and a one-in-three chance of receiving placebo.

Study Details

Inclusion Criteria

  • Has tested positive for SARS COVID-19 within the last 3 days before enrolling in the study
  • Is hospitalized because of COVID -19
  • Has symptoms of COVID-19 within the last 7 days
  • Requires oxygen supplementation

Exclusion Criteria

  • Oxyegn saturation is greater than 94% on room air
  • Does not require oxygen supplementation
  • Is very sick according to the treating physician and not likely to survive beyond 48 hours

Study Requirements

This is a phase 1 first in human study.

Number of research vsitis: Patients are hospitalized and most of the study visits will be done while they are inpatients. Subjects will be followed Day 169. For subjects who are hosptilaized until day 29, and discharged thereafter, there will be weekly visits conducted either by telemedicine or home health nurse or in clinic. For those subjects who are doschsrged before Day 29, there will be daily follow up until Day 29 and then weekly until day 169 thereafter similar to above.

Since this is a phase 1 study, there will be multiple samples drawn for blood drug levels and efficacy of the drug. Blood, urine, nasal swabs, nasopharyngeal swabs and saliva samples will be collected as per the protocol.