A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients

• Status: Active, not recruiting
• Trial end date: 2022-06-02
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose is to evaluate the safety and tolerability of OP-101 and secondary purpose is to determine the effect of OP-101 reducing proinflammatory cytokines after a single dose in severe COVID-19 Patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orpheris, Inc.

Criteria

Key Inclusion Criteria:

• Body mass index (BMI) less than or equal to (<=) 35 kilogram per meter square (kg/m^2)

• Positive laboratory test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or respiratory infection with recent exposure to a person with laboratory-proven SARS-CoV-2

• Hypoxemia defined by saturation of peripheral oxygen (SpO2) of less than (<) 95 percent (%) on room air or Acute respiratory distress syndrome (ARDS)

• Occurrence of at least two of the following criteria: fever greater than (>) 38.0 degree celsius, tachycardia >90 beats/minute, tachypnea >20 breaths/minute, leucocytosis >12*109 per liter (/L) or leucopoenia <4 *109/L

• Participants must have an estimated glomerular filtration rate of greater than or equal to (>=) 45 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2) at screening

Key Exclusion Criteria:

• Not expected to survive for more than 24 hours

• Severe chronic obstructive pulmonary disease requiring long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure used solely for sleep-disordered breathing

• Acute left ventricular failure or myocardial infarction

• Currently receiving extracorporeal membrane oxygenation (ECMO) therapy

• Receiving renal dialysis therapy for chronic renal failure

• Concurrent treatment with immune modulatory study drugs (e.g., anti-IL6 antibodies, Janus kinase (JAK) kinase inhibitors) or other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 within 30 days or 5 half-lives, whichever is longer, prior to dosing with OP-101; except for those that have received FDA emergency-use authorization and have become standard of care (SOC). Concurrent treatment with corticosteroids is permitted if participant has documented continued hypoxemia (SpO2 of <95% on room air) and hyper-inflammation (CRP>=10mg/L) at screening.