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

Launched by MERCK SHARP & DOHME LLC · Oct 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called molnupiravir to see if it can help prevent severe illness from COVID-19 in people who are at high risk. COVID-19 usually causes mild symptoms, but for some individuals—especially those with certain health conditions or older age—there's a greater chance of becoming very sick. The trial is looking for participants who are at least 18 years old, have tested positive for COVID-19 within the last four days, and show specific symptoms like a cough or fever. They also need to have at least one high-risk factor, such as being 75 years or older or having a weakened immune system.

Participants in the trial will be randomly assigned to receive either molnupiravir or a placebo (a substance with no active medicine) to compare the effectiveness. Those who join the study can continue to receive other standard treatments, like remdesivir if needed. It's important to note that this trial is specifically for people who cannot take certain other treatments for COVID-19 due to various reasons, including drug interactions or availability issues. Overall, the goal is to find new ways to help those most vulnerable to serious illness from COVID-19.

Gender

ALL

Eligibility criteria

• • 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 ≥35, diabetes)
• * Is unable 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 renal or hepatic impairment
• • Has experienced prior adverse reactions or hepatotoxicity to NMV/r that would preclude future use
• • Has uncontrolled HIV infection
• • Has known or suspected NMV/r resistance
• • NMV/r is not approved/authorized in the participant's country or it is not accessible to participant (e.g., drug shortage)
• • 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 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
• • Is receiving \>4 liters/minute supplemental oxygen for COVID-19 (but was not receiving supplemental oxygen prior to COVID-19), regardless of SpO2
• • Has received a COVID-19 vaccine within 30 days prior to randomization
• • Has a history of SARS-CoV-2 infection (with or without symptoms) within 30 days prior to randomization
• • Has known or suspected hypersensitivity to active or inactive ingredients of molnupiravir