AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-... | EligiMed

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2 ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF 07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT LOW RISK OF PROGRESSING TO SEVERE ILLNESS

TerminadoFase 3ClinicalTrials.gov

ID: NCT05011513RENIS: IS003532Tipo: INTERVENTIONALInicio: 25 de ago de 2021Fin estimado: 25 de jul de 2022

Traducción no disponible, mostrando original

Resumen

The primary hypothesis to be tested is whether or not there is a difference in time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28 between PF-07321332/ritonavir and placebo.

Descripción detallada

Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or at another non-clinic location, if available. The total study duration is up to 24 weeks.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Confirmed SARS-CoV-2 infection 5 days prior to randomization
Initial onset of COVID-19 signs/symptoms within 5 days of randomization
Fertile participants must agree to use a highly effective method of contraception

Criterios de exclusión

Has at least one underlying medical condition associated with an increased risk of developing severe illness from COVID-19
History of or need for hospitalization for the medical treatment of COVID-19
Prior diagnosis of SARS-CoV-2 infection (reinfection)
Known medical history of liver disease
Receiving dialysis or have known renal impairment
Known Human Immunodeficiency Virus (HIV) infection with viral load \> 400 copies/ml or taking prohibited medications for HIV treatment
Suspected or confirmed concurrent active systemic infection other than COVID-19
Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
Has received or is expected to receive monoclonal antibody treatment or convalescent COVID-19 plasma
Has received any SARS-CoV-2 vaccine within 12 months of screening
Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
Known prior participation in this trial or other trial involving PF-07321332
Oxygen saturation of \< 92% on room air
Females who are pregnant or breastfeeding

Intervenciones

drug

PF-07321332

PF-07321332 (tablet)

drug

Ritonavir

Ritonavir (capsule)

drug

Placebo

Placebo (tablet)

drug

Placebo

Placebo (capsule)

Ubicaciones

Instituto de Investigaciones Clinicas Zarate

Zárate, Buenos Aires, Argentina

Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos)

Rosario, Santa Fe Province, Argentina

Hospital de Clinicas Presidente Nicolas Avellaneda

San Miguel de Tucumán, Tucumán Province, Argentina

Clinica Mayo Urgencias Medicas Cruz Blanca SRL

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Privado Centro Médico de Córdoba

Córdoba, Argentina

Patrocinadores

PrincipalPfizer

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