A Study of ORTD-1 in Patients Hospitalized With COVID-19 Related Pneumonia
NCT ID: NCT04708236
Last Updated: 2021-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2021-04-30
2021-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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ORTD-1 Low dose
Arm 1: ORTD-1
ORTD-1 low dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
ORTD-1 Mid Dose
Arm 2: ORTD-1
ORTD-1 mid dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
ORTD-1 High Dose
Arm 3 : ORTD-1
ORTD-1 high dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Vehicle Control
Arm 4: Vehicle control
Vehicle control
Vehicle Control will be administered intravenously once daily for 5 consecutive days.
Interventions
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ORTD-1 low dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
ORTD-1 mid dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
ORTD-1 high dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Vehicle control
Vehicle Control will be administered intravenously once daily for 5 consecutive days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hospitalized for COVID-19
* Radiographic diagnosis of pneumonia
* Respiratory insufficiency
* Receiving pharmacologic thromboprophylaxis
Exclusion Criteria
* Concurrent or prior intubation or ventilated support for COVID-19
* Receiving systemic corticosteroids or other immunomodulators or immunosuppressant drugs
* Previous hospitalization for COVID-19
18 Years
ALL
No
Sponsors
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Oryn Therapeutics, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Alpesh Amin, MD
Role: PRINCIPAL_INVESTIGATOR
Professor & Chair, Department of Medicine University of California, Irvine
Locations
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UC Irvine Medical Center
Orange, California, United States
Countries
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Other Identifiers
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ORTD1-COV-001
Identifier Type: -
Identifier Source: org_study_id
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