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 INCREASED RISK OF PROGRESSING TO SEVERE ILLNESS

CompletadoFase 3ClinicalTrials.gov

ID: NCT04960202RENIS: IS003539Tipo: INTERVENTIONALInicio: 16 de jul de 2021Fin estimado: 25 de abr de 2022

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether PF-07321332/ritonavir is safe and effective for the treatment of adults who are ill with COVID-19 and do not need to be in the hospital, but are at an increased risk of developing severe illness. Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or 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 within 5 days prior to randomization
Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of randomization and at least 1 of the specified COVID-19 signs/symptoms present on the day of randomization
Fertile participants must agree to use a highly effective method of contraception
Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19

Criterios de exclusión

History of or need for hospitalization for the medical treatment of COVID-19
Prior to current disease episode, any confirmed SARS-CoV-2 infection
Known medical history of active liver disease
Receiving dialysis or have known moderate to severe renal impairment
Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment
Suspected or confirmed concurrent active systemic infection other than COVID-19
History of hypersensitivity or other contraindication to any of the components of the study intervention
Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or are strong inducers of CYP3A4
Has received or is expected to receive convalescent COVID-19 plasma
Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit
Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the long-term follow-up visit
Known prior participation in this trial or other trial involving PF-07321332
Oxygen saturation of \<92% on room air, or on their standard home oxygen supplementation for those who regularly receive chronic supplementary oxygen for an underlying lung condition
Females who are pregnant or breastfeeding

Intervenciones

drug

PF-07321332

PF-07321332 (tablet)

drug

Ritonavir

Ritonavir (capsule)

drug

Placebo

Placebo (tablet or capsule)

Ubicaciones

Instituto de Investigaciones Clinicas Zarate

Zárate, Buenos Aires, Argentina

Hospital De Clínicas Presidente Dr.Nicolas Avellaneda

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalPfizer

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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