A Study to Evaluate the Effectiveness and Safety of Remdesivir to Treat Coronavirus Disease 2019 in an Outpatient Setting

Overview

About this study

The purpose of this study is to evaluate the effietiveness of remdesivir (RDV) in reducing the rate of of all-cause medically attended visits (MAVs; medical visits attended in person by the participant and a health care professional) or death in non-hospitalized participants with early stage coronavirus disease 2019 (COVID-19) and to evaluate the safety of RDV administered in an outpatient setting.

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:

  • Willing and able to provide written informed consent, (individuals ≥ 18 years of age) or assent (individuals ≥ 12 and < 18 years of age) prior to performing study procedures. Individuals age ≥ 18 years may be enrolled with the consent of a legal representative where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC). For individuals ≥ 12 and < 18 years of age, a parent or legal guardian must be willing and able to provide written informed consent prior to performing study procedures.
  • Either:
    • Age ≥ 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 IRB or IEC) with at least 1 of the following pre-existing risk factors for progression to hospitalization:
    • Chronic lung disease: chronic obstructive pulmonary disease, moderate-to-severe asthma, cystic fibrosis, pulmonary fibrosis;
    • Hypertension: systemic or pulmonary;
    • Cardiovascular or cerebrovascular disease: coronary artery disease, congenital heart disease, heart failure, cardiomyopathy, history of stroke, atrial fibrillation, hyperlipidemia;
    • Diabetes mellitus: Type 1, type 2, or gestational;
    • Obesity (BMI 30);
    • Immunocompromised state; having a solid organ transplant, blood, or bone marrow transplant; immune deficiencies; HIV with a low CD4 cell count or not on HIV treatment; prolonged use of corticosteroids; or use of other immune weakening medicines;
    • Chronic mild or moderate kidney disease;
    • Chronic liver disease;
    • Current cancer;
    • Sickle cell disease; OR
    • Age ≥ 60 years, regardless of the presence of other pre-existing risk factors for progression.
  • SARS-CoV-2 infection confirmed by molecular diagnostics (nucleic acid [e.g., PCR] or antigen testing) ≤ 4 days prior to screening.
  • Presence of ≥ 1 symptom(s) consistent with COVID-19 for ≤ 7 days prior to randomization (such as fever, cough, fatigue, shortness of breath, sore throat, headache, myalgia/arthralgia) {Stokes 2020, World Health Organization (WHO) 2020b}.
  • Not currently receiving, requiring, or expected to require supplemental oxygen.
  • Not currently requiring hospitalization (hospitalization defined as ≥ 24 hours of acute care).
  • Participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.

Exclusion Criteria:

  • Participation in any other clinical trial of an experimental treatment and prevention for COVID-19.
  • Prior hospitalization for COVID-19 (hospitalization defined as ≥ 24 hours of acute care).
  • Treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 or administration of any SARS-CoV-2 (or COVID-19) vaccine.
  • Requiring oxygen supplementation.
  • ALT or AST ≥ 5 × upper limit of normal (ULN) at screening or within 90 days of screening.
    • Note: if per local practice only ALT is routinely measured, exclusion criteria will be evaluated on ALT alone.
  • Creatinine clearance < 30 mL/min at screening or within 90 days of screening using the Cockcroft-Gault formula in participants ≥ 18 years of age or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2 at screening or within 90 days of screening using the Schwartz formula in participants < 18 years of age.
  • Currently breastfeeding (nursing).
  • Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
  • Use or planned use of exclusionary medications.

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

Raymund Razonable, M.D.

Contact us for the latest status

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

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions