Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
estimated completion

Description

Summary

This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29

Official Title

A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults With COVID-19.

Keywords

Coronavirus Disease (COVID-19) Coronavirus Infections Molnupiravir

Eligibility

You can join if…

Open to people ages 18 years and up

  • Has documentation of polymerase chain reaction (PCR)-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with sample collection ≤7 days prior to randomization. PCR is the preferred method; however other diagnostic methods are allowed if authorized by use in the country.
  • Has initial onset of signs/symptoms attributable to COVID-19 for ≤7 days prior to randomization and at least 1 sign/symptom attributable to COVID-19 on the day of randomization
  • Has mild or moderate COVID-19. Participants with mild COVID-19 must have at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19
  • Has oxygenation saturation of >93% (on room air OR on supplemental oxygen prior to randomization which has not increased since onset of COVID-19 signs/symptoms) obtained at rest by study staff at randomization.
  • Is willing and able to take oral medication
  • Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: Refrain from donating sperm; and either abstain from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception
  • Females are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least 7 months after the last dose of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.

You CAN'T join if...

  • Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization
  • Is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation

  • Has any of the following conditions: human immunodeficiency virus (HIV) with a recent viral load >50 copies/mL or cluster of differentiation 4 (CD4) <200 cell/mm3; chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count <500/mm3; autologous or allogeneic hematopoietic stem cell transplant recipient

  • Has an active diagnosis of hepatitis due to any cause
  • Has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis
  • Is taking or is anticipated to require any prohibited therapies
  • Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics
  • Has a baseline heart rate of < 50 beats per minute at rest
  • Has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization.
  • Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
  • Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization, participants who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation not associated with COVID-19, or participants with conditions that could limit gastrointestinal absorption of capsule contents.

Locations

  • UC Davis Medical Center ( Site 1833) accepting new patients
    Sacramento California 95817 United States
  • Ruane Clinical Research Group, Inc. ( Site 2406) accepting new patients
    Los Angeles California 90036 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme Corp.
ID
NCT04575597
Phase
Phase 2/3
Study Type
Interventional
Last Updated