Status:
WITHDRAWN
A Study of ORTD-1 in Patients Hospitalized With COVID-19 Related Pneumonia
Lead Sponsor:
Oryn Therapeutics, LLC
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Evaluate the safety and effect of ORTD-1 on COVID-19 related pneumonia.
Detailed Description
This is a randomized, blinded, vehicle-controlled dose-escalation study. Initial enrollment and treatment will be conducted as an inpatient study. Patients will be randomized 2:1, ORTD-1 treatment ver...
Eligibility Criteria
Inclusion
- Positive RT-PCR assay for SARS CoV-2 in a respiratory tract sample
- Hospitalized for COVID-19
- Radiographic diagnosis of pneumonia
- Respiratory insufficiency
- Receiving pharmacologic thromboprophylaxis
Exclusion
- Premorbid abnormal pulmonary function or disease
- Concurrent or prior intubation or ventilated support for COVID-19
- Receiving systemic corticosteroids or other immunomodulators or immunosuppressant drugs
- Previous hospitalization for COVID-19
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04708236
Start Date
April 1 2021
End Date
July 1 2021
Last Update
June 14 2021
Active Locations (1)
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1
UC Irvine Medical Center
Orange, California, United States, 92868