A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Percentage of Participants Who Experienced One or More of Following Through Day 29: All-cause Hospitalization, All-cause Mortality, or Covid-19-related Medically-attended Visit (MAV) — Up to 29 days
Hospitalization is defined as ≥24 hours of acute care in a hospital or similar acute care facility, including emergency rooms or facilities created to address hospitalization needs specifically for COVID-19. Hospitalization and death may be due to any cause. An MAV is defined as any unscheduled, nonroutine healthcare visit where the participant is evaluated by a licensed (according to local/national guidelines) healthcare provider. As prespecified by the protocol, the percentage of participants who experience ONE OR MORE of these 3 events (hospitalization, death, or COVID-19-related MAV) occurring from randomization through Day 29 will be presented. - Percentage of Participants Who Experienced an Adverse Event (AE) — Up to approximately 5 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with at least 1 AE will be presented. - Percentage of Participants Who Discontinued Study Intervention Due to AE — Up to approximately 5 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study intervention due to an AE will be presented.
Trial sites (226)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | Completed |
| 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 |
+ 186 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 Mexico
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 Mexico