A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 2 REGIMENS OF ORALLY ADMINISTERED PF 07321332/RITONAVIR IN PREVENTING SYMPTOMATIC SARS-COV-2 INFECTION IN ADULT HOUSEHOLD CONTACTS OF AN INDIVIDUAL WITH SYMPTOMATIC COVID-19

CompletadoFase 3ClinicalTrials.gov

ID: NCT05047601RENIS: IS003548Tipo: INTERVENTIONALInicio: 9 de sept de 2021Fin estimado: 12 de abr de 2022

Traducción no disponible, mostrando original

Resumen

The purpose of this clinical trial is to learn whether the study medicine prevent symptoms of COVID-19 in adults who have been exposed to household member(s) with a confirmed symptomatic COVID-19 infection. All participants in the study will receive treatment for COVID-19 as needed, based on their regular doctor's recommendation. Two-thirds of participants will also receive two study medicines (PF-07321332 and ritonavir) by mouth twice a day for either five or ten days. We will compare the experiences of people receiving the study medicines to those of the people who do not. This will help us determine if the study medicines are safe and effective

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants who have a negative screening SARS-CoV-2 rapid antigen test result and who are asymptomatic household contacts with exposure within 96 hours to an individual who is symptomatic and recently tested positive for SARS CoV-2.
Fertile participants must agree to use a highly effective method of contraception

Criterios de exclusión

History of SARS-CoV-2 infection in the past 6 months
Experiencing measured fever (documented temperature \>38˚C or 100.4˚F) or other signs or symptoms consistent with COVID-19
Known medical history of active liver disease
Chronic Kidney Disease or have known moderate to severe renal impairment.
Known Human Immunodeficiency Virus (HIV) infection with viral load \> 400 copies/ml within the last 6 months or taking prohibited medications for HIV treatment
Suspected or confirmed concurrent active systemic infection
Active cancer requiring treatment with prohibited medication.
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 approved, authorized, or investigational anti-SARS-CoV-2 mAb, convalescent plasma, other drugs for treatment of COVID-19, or other anti-SARS-CoV-2 biologic products within 6 months of screening
Has received any SARS-CoV-2 vaccine within 6 months prior to screening or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments through Day 38.
Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
Known or prior participation in this trial or another trial involving PF-07321332.
Females who are pregnant or breastfeeding.

Intervenciones

drug

PF-07321332

drug

Placebo for PF-07321332

Placebo

drug

Placebo for Ritonavir

Placebo

drug

Ritonavir

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

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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