Phase 2a MIB-626 vs. Placebo COVID-19

This is an interventional treatment trial for Covid19 focused on measuring MIB-626, Covid19, Early Acute Kidney Injury, NAD-boosting drug Read More

Inclusion Criteria:

• A man or a woman, 18 years or older
• Willing and able to provide informed consent, or with a legal representative who can provide informed consent with participant's assent
• Has Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by an approved diagnostic test before randomization
• Currently hospitalized
• Documented increase in serum creatinine of 0.3 mg/dL or 50%-99% over baseline (baseline either based on admission serum creatinine or known pre-admission baseline, defined as most recent previous measurement)
• Participant or legal representative has read and signed the Informed Consent Form (ICF) after the nature of the study has been fully explained
• Is willing and able to provide authorization for the use and disclosure of personal health information in accordance with Health Insurance Portability and Accountability Act (HIPAA)
• Patients who are receiving remdesivir as a part of their clinical care or are in clinical trials of remdesivir or other antiviral drugs may be allowed if they meet other eligibility criteria
• Patients, who are participating in observational studies or studies of nonpharmacological interventions, will be allowed to participate
• Not be pregnant and not planning to become pregnant over the next 6 months

Exclusion Criteria:

• In the intensive care unit at the time of screening or prior to randomization
• Requiring mechanical ventilation at the time of screening or prior to randomization
• Has baseline estimated glomerular filtration rate < 30 ml/min/1.73m2
• Has a history of kidney transplantation or hemodialysis treatment or receiving or expected to receive hemodialysis or peritoneal dialysis at screening and prior to randomization
• Is on mechanical ventilation
• Has a contraindication for MIB-626 or its inert ingredients
• Has a diagnosis of lupus nephritis, polycystic kidney disease, other glomerular disease (other than diabetes)
• Has AST or ALT > 3 times the upper limit of normal
• Has other medical condition which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject or impact the validity of the study results
• Will exclude patients, who are receiving or are enrolled in placebo-controlled intervention trials of anti-inflammatory or immunomodulatory agents, such as tocilizumab. Occasional use of acetaminophen and nonsteroidal anti-inflammatory drugs, such as ibuprofen, for fever or headache is permitted.