Resumen

Los investigadores están evaluando otras formas de prevenir la enfermedad grave por COVID-19. La COVID-19 es un virus que con mayor frecuencia causa síntomas leves similares a los de la gripe o el resfriado. Sin embargo, las personas con ciertas afecciones de salud u otros factores tienen un alto riesgo de enfermar gravemente a causa de la COVID-19, lo que puede requerir hospitalización o provocar la muerte. Algunas personas con alto riesgo de enfermedad grave pueden no poder recibir ciertos tratamientos para la COVID-19 porque no están disponibles para ellas, o porque toman otros medicamentos que podrían interactuar con el tratamiento y causar un efecto no deseado. Molnupiravir (MK-4482) es un medicamento en investigación diseñado para impedir que el virus de la COVID-19 se replique en el organismo (multiplicación). El objetivo de este estudio es determinar si molnupiravir previene la enfermedad grave por COVID-19 en mayor medida que el placebo en personas con alto riesgo.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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

Ubicaciones

CEMIC ( Site 0101)

Buenos Aires., Buenos Aires, Argentina

Study Coordinator · +54-911-36115955

RECRUITING

Hospital Italiano de Buenos Aires ( Site 0107)

Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina

Study Coordinator · +54-911-36115955

RECRUITING

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0111)

Mar del Plata, Buenos Aires, Argentina

Study Coordinator · +542234963224

RECRUITING

Nefra Medical Care - Moron ( Site 0109)

Morón, Buenos Aires, Argentina

Study Coordinator · +541146291083

RECRUITING

Estudio clínico de fase 3, aleatorizado, controlado con placebo, doble ciego, para evaluar la eficacia y seguridad de molnupiravir (MK-4482) en adultos no hospitalizados con COVID-19 con alto riesgo de progresión de la enfermedad

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Molnupiravir

Placebo

Ubicaciones

CEMIC ( Site 0101)

Hospital Italiano de Buenos Aires ( Site 0107)

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0111)

Nefra Medical Care - Moron ( Site 0109)

Patrocinadores

Contactos

Toll Free Number