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

  • STATUS
    Recruiting
  • participants needed
    24
  • sponsor
    Orpheris, Inc.
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Updated on 5 August 2020
See if I qualify
body mass index
cytokines
fever
respiratory distress
covid-19
SARS
respiratory tract infection
coronavirus infection
respiratory infection
acute respiratory distress
acute respiratory syndrome (sars)

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.

Details
Condition Covid 19
Age 18years - 100years
Treatment Placebo, OP-101
Clinical Study IdentifierNCT04458298
SponsorOrpheris, Inc.
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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 >12109 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

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)
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body mass index
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acute respiratory distress
acute respiratory syndrome (sars)

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