Overview
A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2022-06-02
2022-06-02
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
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.