ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19

Overview

About this study

The primary objective of this study is to evaluate the clinical effectiveness of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.

 

 

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 with symptoms suggestive of Coronavirus Disease 2019 (COVID-19) and requires ongoing medical care.
  • 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 adult ≥ 18 years of age at time of enrollment.
  • Illness of any duration and has laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay (e.g., Nucleic Acid Amplification Test [NAAT], antigen test) in any respiratory specimen, or saliva 5 times the upper limit of normal.
  • Illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or ECMO (ordinal scale category 5, 6, or 7). 
  • Women of childbearing potential must agree to either abstinence or use at least one acceptable method of contraception from time of screening through 5 months post study IP dosing.
    • Note: acceptable methods include barrier contraceptives (condoms or diaphragms) with spermicide, intrauterine devices (IUDs), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. 
  • Agrees not to participate in another blinded clinical trial (both pharmacologic and other types of interventions) for the treatment of COVID-19 through day 29. 

Exclusion Criteria:

  • ALT or AST > 5 times the upper limit of normal. 
  • Subjects with a low glomerular filtration rate (eGFR), specifically:
    • Subjects with a glomerular filtration rate (eGFR) 20-30 mL/min are excluded unless in the opinion of the principal investigator (PI), the potential benefit of participation outweighs the potential risk of study participation;
    • All subjects with a glomerular filtration rate (eGFR) < 20 mL/min (including hemodialysis and hemofiltration) are excluded.
  • Pregnancy or breast feeding.
  • Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours of enrollment.
  • Allergy to any study medication.
  • Received five or more doses of remdesivir prior to screening.
  • Received two or more doses of > 60 mg of prednisone or equivalent in the 7 days prior to screening.
  • Received small molecule tyrosine kinase inhibitors, including Janus kinase (JAK) inhibitors (e.g., baricitinib, ibrutinib, acalabrutinib, imatinib, gefitinib), in the 4 weeks prior to screening.
  • Received monoclonal antibodies targeting cytokines (e.g., tumor necrosis factor (TNF) inhibitors, anti-IL-1 [e.g., anakinra, canakinumab], anti-IL-6 [e.g., tocilizumab, sarilumab, sitlukimab]), or T-cells (e.g., abatacept) in the 4 weeks prior to screening.
  • Received monoclonal antibodies targeting B-cells (e.g., rituximab, and including any targeting multiple cell lines including B-cells) in the 3 months prior to screening.
  • Received granulocyte-macrophage colony-stimulating factor (GM-CSF) agents (e.g., sargramostim) within 2 months prior to screening.
  • Received other immunosuppressants in the 4 weeks prior to screening and in the judgement of the investigator, the risk of immunosuppression with lenzilumab is larger than the risk of Coronavirus Disease 2019 (COVID-19).
  • Received any live vaccine in the 4 weeks prior to screening.
  • Known active tuberculosis.
  • Known history of Human Immunodeficiency Virus (HIV), Hepatitis B (HBV) or untreated hepatitis C (HCV) infection.
  • History of pulmonary alveolar proteinosis (PAP).
  • Has a malignancy currently receiving immunosuppressive chemotherapy, immunodeficiency, uncontrolled opportunistic infection, or uncontrolled cirrhosis.
  • Has a medical condition that could, in the judgment of the investigator, limit the interpretation and generalizability of trial results.
  • Positive test for influenza virus during the current illness (influenza testing is not required by protocol).
  • Previous participation in an ACTIV-5/Big Effect Trial (BET).

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

Jacksonville, Fla.

Mayo Clinic principal investigator

Lisa Brumble, M.D.

Closed for enrollment

Rochester, Minn.

Mayo Clinic principal investigator

Zelalem Temesgen, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
.

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