🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT06667700
Recruiting Phase 3

A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)

NCT06667700 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2024-12-02
Last updated
2026-09-18

Condition(s) studied

Coronavirus Disease (COVID-19)

Investigational drug(s) / intervention(s)

Molnupiravir →Placebo

Molnupiravir: Molnupiravir administered orally as two 400 mg film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)

Placebo: Molnupiravir-matching placebo administered orally as two film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)

Study summary

Researchers are looking for other ways to prevent severe illness from COVID-19. COVID-19 is a virus that most often causes mild flu or cold-like symptoms. However, people with certain health conditions or other factors have a high risk (chance) of getting severely ill from COVID-19, which can require a hospital stay or lead to death. Some people who are high risk for severe illness may be unable to take certain treatments for COVID-19 because they are not available to them, or they take other medicines that may react with a treatment and cause an unwanted effect.

Molnupiravir (MK-4482) is a study medicine designed to stop the COVID-19 virus from copying itself in the body (multiplying). The goal of this study is to learn if molnupiravir prevents severe illness from COVID-19 more than placebo in people who are high risk.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria The main inclusion criteria include but are not limited to the following: * Is an individual of any sex/gender, ≥18 years of age * Has documentation of SARS-CoV-2 infection with sample collection ≤4 days prior to randomization * Has initial onset of signs/symptoms attributable to COVID-19 for ≤4 days prior to the day of randomization and ≥2 of the following signs/symptoms attributable to COVID-19 on the day of randomization: cough, sore throat, nasal congestion, shortness of breath or difficulty breathing with exertion, muscle or body aches, fatigue, fever \>38.0°C or chills, nausea or vomiting or diarrhea, change in sense of smell or change in sense of taste, or headache * Has ≥1 of the following characteristics or medical conditions associated with the highest risk of severe illness from COVID-19: * Advanced age of ≥75 years of age * Immunocompromised * Neurocognitive or physical disability * Has ≥3 characteristics or medical conditions which increase the risk of severe illness due to COVID-19 (e.g., chronic lung disease, obesity with body mass index (BMI) ≥35, diabetes) * Is unable or unwilling to receive treatment with nirmatrelvir/ritonavir (NMV/r) due to 1 or more of the following: * Is receiving drug(s) highly dependent on cytochrome P450 3A (CYP3A) for clearance and for which elevated concentrations are associated with serious and/or life-threatening consequences or drug(s) with a clinically significant drug-drug interaction for which co-administration is not possible * Is receiving potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance * Has severe hepatic impairment * Has experienced prior adverse reactions or hepatotoxicity to NMV/r that would preclude future use * Has known or suspected NMV/r resistance * Has uncontrolled HIV infection * NMV/r is not approved/authorized in the participant's country or it is not accessible to participant (e.g., drug shortage) * Is unwilling to receive treatment with NMV/r Inclusion note: Participants may receive remdesivir as standard of care in addition to molnupiravir or placebo. If remdesivir is available and clinically appropriate per local clinical practice, investigators will aim to ensure that those who are most vulnerable to severe COVID-19 receive timely access to remdesivir as standard of care on this study. Exclusion Criteria The main exclusion criteria include but are not limited to the following: * Is currently hospitalized or is expected to need hospitalization for COVID-19 imminently * Has received or plans to receive SARS-CoV-2 directed oral antivirals or monoclonal antibodies for current episode of COVID-19 (other than study intervention and, if applicable, remdesivir as standard of care) * Has ≥1 of the following signs/symptoms that are attributable to severe or critical COVID-19: * Shortness of breath at rest * Respiratory rate ≥30 breaths per minute * Heart rate ≥125 beats per minute * Peripheral oxygen saturation (SpO2) ≤93% on room air or on supplemental oxygen for a reason other than COVID-19 which has not increased since onset of COVID-19 signs/symptoms * New or increasing need for supplemental oxygen: receiving \>4 liters/minute supplemental oxygen due to COVID-19 OR on supplemental oxygen for a reason other than COVID-19 which has increased due to COVID-19 * Has received a COVID-19 vaccine within 30 days prior to randomization * Has a history of confirmed influenza, respiratory syncytial virus (RSV), or SARS-CoV-2 infection (with or without symptoms; excluding current infection) within 30 days prior to randomization * Has known or suspected hypersensitivity to active or inactive ingredients of molnupiravir

Primary outcome measure(s)

Trial sites (224)

FacilityCityRegionStatus
Cullman Clinical Trials ( Site 3813) Cullman Alabama Completed
Helios Clinical Research ( Site 3826) Paradise Valley Arizona Recruiting
Absolute Clinical Research ( Site 3709) Phoenix Arizona Completed
Clinica de Salud del Valle de Salinas ( Site 3825) Castroville California Recruiting
Ascada Health PC dba Ascada Research ( Site 3750) Fullerton California Completed
Pacific Clinical Studies ( Site 3827) Los Alamitos California Recruiting
Valley Clinical Trials, Inc. ( Site 3707) Northridge California Recruiting
FOMAT Medical Research ( Site 3720) Oxnard California Recruiting
Paradigm Clinical Research, LLC ( Site 3785) San Diego California Recruiting
Optimus Medical ( Site 3817) San Francisco California Recruiting
Millennium Clinical Trials ( Site 3758) Westlake Village California Recruiting
Paradigm Clinical Research Centers, Inc ( Site 3718) Wheat Ridge Colorado Recruiting
Encore Medical Research of Boynton Beach ( Site 3701) Boynton Beach Florida Recruiting
Prestige Clinical Research Center ( Site 3722) Coral Gables Florida Recruiting
Prestige Clinical Research ( Site 3830) Homestead Florida Recruiting
Accel Research Sites Network - St. Pete-Largo Clinical Research Unit ( Site 3779) Largo Florida Recruiting
Clinical Site Partners, LLC dba Flourish Research ( Site 3717) Leesburg Florida Recruiting
Advanced Pulmonary Research Institute ( Site 3781) Loxahatchee Groves Florida Active Not Recruiting
Southern Clinical Research ( Site 3773) Miami Florida Recruiting
Florida Pharmaceutical Research and Associates ( Site 3763) Miami Florida Recruiting
Bio-Medical Research LLC ( Site 3804) Miami Florida Recruiting
Bright Research Center ( Site 3746) Miami Florida Completed
Miami Clinical Research ( Site 3729) Miami Florida Recruiting
Reed Medical Research ( Site 3761) Miami Florida Recruiting
Palm Springs Community Health Center ( Site 3757) Miami Lakes Florida Recruiting
Panax Clinical Research ( Site 3803) Miami Lakes Florida Recruiting
Indago Research and Health Center Inc ( Site 3714) Miami Lakes Florida Recruiting
Combined Research Orlando Phase I-IV ( Site 3797) Orlando Florida Recruiting
CDC Research Institute ( Site 3716) Port Saint Lucie Florida Recruiting
New Tampa Health ( Site 3764) Tampa Florida Recruiting
Clinical Research Trials of Florida ( Site 3703) Tampa Florida Recruiting
Precision Research Center ( Site 3704) Tampa Florida Recruiting
Encore Medical Research - Weston ( Site 3708) Weston Florida Completed
Balanced Life Health Care Solutions/SKYCRNG ( Site 3713) Lawrenceville Georgia Recruiting
Renew Health Clinical Research ( Site 3760) Snellville Georgia Recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG ( Site 3816) Union City Georgia Completed
Paradigm Clinical Research - Boise ( Site 3841) Boise Idaho Active Not Recruiting
Rush University Medical Center ( Site 3748) Chicago Illinois Recruiting
Duly Health and Care ( Site 3799) Lombard Illinois Recruiting
University of Louisville School of Medicine ( Site 3706) Louisville Kentucky Recruiting

+ 184 more sites — see the full list on the official registry below.

On this site

📄 Lagevrio (molnupiravir) drug profile →

More Merck Sharp & Dohme LLC trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06667700 on ClinicalTrials.gov ↗ ← All trials in Germany