| Participants |
Setting
Inpatient Multicentre, USA
Eligibility criteria
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Inclusion criteria
Admitted to a hospital with symptoms suggestive of COVID‐19 and requires ongoing medical care Participant(or LAR) provides informed consent prior to initiation of any study procedures Participant(or LAR) understands and agrees to comply with planned study procedures Male or non‐pregnant female adult ≥ 18 years of age at time of enrolment Has laboratory‐confirmed SARS‐CoV‐2 infection as determined by PCR or other commercial or public health assay in any specimen, collected < 72 hours prior to screening; OR in sample collected >/= 72 hours but < 14 days prior to screening AND non‐improving or progressive disease suggestive of ongoing SARS‐CoV‐2 infection Illness of any duration, and requiring, just prior to randomisation, supplemental oxygen (any flow), mechanical ventilation or ECMO (ordinal scale category 5, 6, or 7) WOCBP must agree to either abstinence or use at least one acceptable method of contraception from the time of screening through 5 months post study intraperitoneal (IP) dosing 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
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Exclusion criteria
ALT or AST > 5 times ULN Pregnancy or breastfeeding Anticipated discharge from the hospital or transfer to another hospital that is not a study site within 72 hours of enrolment Allergy to any study medication Received ≥ 5 doses of remdesivir prior to screening Received ≥ 2 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 mAbs targeting cytokines (e.g. tumour 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 mAbs targeting 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 Received any live vaccine in the 4 weeks prior to screening Known active tuberculosis, history of HIV, Hepatitis B (HBV) or untreated hepatitis C (HCV) infection, pulmonary alveolar proteinosis (PAP) Has active malignancy, immunodeficiency, uncontrolled opportunistic infection, or uncontrolled cirrhosis Has a medical condition that could, in the judgment of the investigator, limit the interpretation and generalisability of trial results Positive test for influenza virus during the current illness Previous participation in an ACTIV‐5/BET trial
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| Outcomes |
Efficacy outcomes
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All‐cause mortality
Clinical progression/improvement of symptoms: planned Length of hospital stay: planned Admission to ICU: not planned Length of ICU stay: not planned Quality of life, including fatigue: not planned Viral clearance: not planned
Safety outcomes
Additional study outcomes
Clinical efficacy in adults hospitalised with COVID‐19 according to clinical status on an 8‐point ordinal scale Day of recovery Change from baseline in C‐reactive protein (CRP) concentration, d‐dimer concentration, ferritin concentration, fibrinogen concentration, troponin concentration, ALT, AST, creatinine, haemoglobin, international normalised ratio (INR), platelets, total bilirubin over time, WBC count Clinical efficacy, as assessed by time to recovery Discontinuation or temporary suspension of study product administration Subject 14‐day mortality Proportion of participants alive and without respiratory failure
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