Study to Evaluate the Effectiveness and Safety of Remdesivir in Participants with Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019

Overview

About this study

The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (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.

Inclusion Criteria:

  • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) positive as determined by Polymerase Chain Reaction (PCR) or other commercially available or public health assay (e.g., Nucleic Acid Amplification Test [NAAT] and antigen tests) in any respiratory specimen.
  • Hospitalized for COVID-19.
  • Age ≥ 12 years and weighing at least 40 kg.
  • Oxygen (O2) saturation ≤ 94% on room air or requiring O2 supplement or Radiographic evidence of pulmonary infiltrates for COVID-19.
  • Have either:
    • Severely reduced kidney function (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73m^2 ), using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and revised Schwartz equations for adults and adolescents, respectively, including people with ESKD requiring chronic dialysis but not people requiring RRT for AKI;
    • Adults: eGFR (mL/min/1.73 m²) 141 × min(SCr/κ, 1)α × max(SCr/κ, 1)-1.209 × 0.993Age × 1.018 [if female] × 1.159 [if African American]
    • κ = 0.7 for females; 0.9 for males α = -0.329 for females; -0.411 for males
    • Adolescents (age 12–17 years): eGFR (mL/min/1.73 m²) = (0.41 × Height in cm) / SCr
    • SCr in mg/dL, age in years;
    • Ongoing AKI: defined as a 50% increase in SCr within a 48-hour period that is sustained (ie, requires confirmatory SCr) for ≥ 6 hours despite supportive care.
  • Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under ICH E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥ 18) prior to performing study procedures.
  • The interval between COVID-19 symptoms onset and randomization is no more than 10 days.
  • Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.

Exclusion Criteria:

  • Received any investigational drug, RDV, or other antiviral treatment for COVID-19.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal.
  • Invasive mechanical ventilation, noninvasive mechanical ventilation, ECMO, or RRT for acute kidney injury (AKI).
  • Positive serum pregnancy test at screening for women of childbearing potential or currently breastfeeding.
  • Known hypersensitivity to the study drug, metabolites, or formulation sulfobutylether-beta-cyclodextrin (SBECD).

Eligibility last updated 11/9/21. Questions regarding updates should be directed to the study team contact.

 

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

Maria Gonzalez Suarez, M.D., Ph.D.

Open for enrollment

Contact information:

Department of Medicine - Clinical Trials Unit

(507) 266-1944

RSTDOMCTU@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Fernando Stancampiano, M.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available
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CLS-20513360

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