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

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Stacey Rizza, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Department of Medicine - Clinical Trials Unit

(507) 266-1944

RSTDOMCTU@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20483605

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