A Study to Evaluate Agents to Treat Moderately or Severely Ill Patients with Severe Acute Respiratory Syndrome Coronavirus 2

Overview

About this study

This study aims to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in accordance with national or local guidelines, which may include remdesivir. 

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:

  • Admitted to a hospital or awaiting admission in the ED with symptoms suggestive of COVID-19.
  • Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
  • Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
  • Male or non-pregnant female adults ≥ 18 years of age at time of enrollment.
  • Has laboratory-confirmed (within 14 days prior to enrollment) SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen.
  • Ongoing illness of any duration, and at least one of the following:
    • Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.).
    • Blood oxygen saturation (SpO2) ≤ 94% on room air.
    • Requiring supplemental oxygen.
    • Requiring mechanical ventilation or ECMO.
  • Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 60.
  • Agrees to not participate in another intervention trial for the treatment of COVID-19 through Day 60.

Exclusion Criteria:

  • ALT or AST > 5 times the upper limit of normal.
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min (including patients receiving hemodialysis or hemofiltration).
  • Neutropenia (absolute neutrophil count < 1000 cells/μL) (<1.0 x 10^3/μL or < 1.0 GI/L).
  • Lymphopenia (absolute lymphocyte count < 200 cells/μL) (< 0.20 x 10^3/μL or < 0.20 GI/L).
  • Pregnancy or breast feeding.
  • Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
  • Known Allergy to any study medication.
  • Received cytotoxic or biologic treatments (such as anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], IL-17, or T-cell or B-cell targeted therapies (e.g., rituximab), tyrosine kinase inhibitors including baricitinib, TNF inhibitors, or interferon within 4 weeks or 5 half-lives prior to screening. Steroid dependency defined as need for prednisone at a dose > 10 mg (or equivalent) for > 1 month within 2 weeks of screening is exclusionary.
    • Note 1: Dexamethasone (at a dose of 6 mg per day for up to 10 days) is permitted for the treatment of COVID-19 in patients who are already mechanically ventilated and in patients who require supplemental oxygen at screening, but who are not mechanically ventilated in accordance with national guidelines.
    • Note 2: Infusion of convalescent plasma is also allowed.
  • Based on medical history and concomitant therapies that would suggest infection, have suspected clinical diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required).
  • Based on medical history and concomitant therapies that would suggest infection, suspected serious, active bacterial, fungal, viral (including, but not limited to, active HBV, HCV, or HIV/AIDS).
  • Have received any live vaccine (that is, live attenuated) within 3 months before screening, or intend to receive a live vaccine (or live attenuated) during the study.
    • Note: Use of non-live (inactivated) vaccinations is allowed for all participants.
  • Severe hepatic impairment (defined as liver cirrhosis Child stage C).
  • Current severe heart failure (New York Heart Association [NYHA] III-IV).
  • In the Investigator's judgment, the patient has any advanced organ dysfunction that would not make participation appropriate.

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

Vivek Iyer, M.D., M.P.H.

Open for enrollment

Contact information:

Pulmonary Clinical Research Unit

(800) 753-1606

PCRUE18@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available