Last updated 4 days ago

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

3082 patients around the world
Available in Puerto Rico, Argentina
Merck Sharp & Dohme LLC
4Research sites
3082Patients around the world

This study is for people with

Covid-19
Covid-19 pneumonia

Requirements for the patient

From 18 Years
All Gender

Medical requirements

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).
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.
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.

Sites

Instituto de Investigaciones Clínicas Mar del Plata
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Av. Colón 3456, Mar del Plata, Buenos Aires
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Juan Domingo Perón 4190, Piso 1, Ciudad Autónoma de Buenos Aires, C1181ACH
Fresenius Medical Care Morón
Recruiting
Mariano Moreno 1071, Morón, Buenos Aires
Instituto Universitario CEMIC - CABA
Recruiting
Valdenegro 4337, C1430EFA Cdad. Autónoma de Buenos Aires, Argentina
LinkedinInstagramFacebook
Terms and ConditionsPrivacy Policy