Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19) (enrollment by invitation only)

Overview

Información sobre este estudio

The purpose of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to the normalization of temperature and oxygen saturation through Day 14 in participants with severe coronavirus disease (COVID-19).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Key Inclusion Criteria:

  • Willing and able to provide written informed consent (participants ≥ 18 years of age) or assent (participants ≥ 12 and < 18 years of age, where locally and nationally approved) prior to performing study procedures.   For participants ≥ 12 and < 18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures.
  • Aged ≥ 18 years (at all sites), or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board [IRB] or independent ethics committee [IEC]).
  • SARS-CoV-2 infection confirmed by PCR test ≤ 4 days before randomization.
  • Currently hospitalized.
  • SpO2 ≤ 94% on room air or requiring supplemental oxygen at screening.
  • Radiographic evidence of pulmonary infiltrates.
  • Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Key Exclusion Criteria:

  • Participation in any other clinical trial of an experimental treatment for COVID-19.
  • Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing.
  • Evidence of multiorgan failure.
  • Mechanically ventilated (including V-V ECMO) ≥ 5 days, or any duration of V-A ECMO.
  • ALT or AST > 5 x ULN.
  • Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of age.
  • Positive pregnancy test.
  • Breastfeeding woman.
  • Known hypersensitivity to the study drug, the metabolites, or formulation excipient.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Stacey Rizza, M.D.

Cerrado para la inscripción

More information

Publicaciones

  • Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19). Read More on PubMed

Información adicional de contacto

Formulario de contacto para ensayos que no son sobre cáncer

Teléfono: 800-664-4542 (llamada gratis)

Preguntas de estudios clínicos para pacientes internacionales