- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04708236
A Study of ORTD-1 in Patients Hospitalized With COVID-19 Related Pneumonia
June 9, 2021 updated by: Oryn Therapeutics, LLC
A Blinded, Controlled, Escalating Dose Study of ORTD-1 for Treatment of Hospitalized Patients With SARS-CoV-2 (COVID-19) Related Pneumonia.
Evaluate the safety and effect of ORTD-1 on COVID-19 related pneumonia.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 versus vehicle control.
Patients will be allocated into 1 of 3 sequential escalating dose cohorts.
Blinded study drug will be infused intravenously once daily for 5 consecutive days.
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Orange, California, United States, 92868
- UC Irvine Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ORTD-1 Low dose
Arm 1: ORTD-1
|
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Other Names:
|
Experimental: ORTD-1 Mid Dose
Arm 2: ORTD-1
|
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Other Names:
|
Experimental: ORTD-1 High Dose
Arm 3 : ORTD-1
|
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Other Names:
|
Placebo Comparator: Vehicle Control
Arm 4: Vehicle control
|
Vehicle Control will be administered intravenously once daily for 5 consecutive days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: Through Day 65
|
Number of participants with treatment-emergent adverse events
|
Through Day 65
|
Incidence of laboratory abnormalities
Time Frame: Through Day 65
|
Number of participants with Grade 3 or higher laboratory abnormalities
|
Through Day 65
|
Incidence of anti-drug antibodies
Time Frame: Through Day 65
|
Number of participants who develop antibodies to ORTD-1
|
Through Day 65
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients requiring intubation
Time Frame: Day 1-65
|
The requirement of intubation and invasive ventilation will be assessed for patients at each visit.
|
Day 1-65
|
Percentage of days requiring supplemental oxygen
Time Frame: Day 1-65
|
Percentage of days for which the patient requires supplemental oxygen will be recorded.
|
Day 1-65
|
Overall survival (OS)
Time Frame: Day 1-65
|
Overall survival is defined as the time from enrollment until death from any cause.
|
Day 1-65
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peripheral blood oxygen levels (SpO2)
Time Frame: Day 1-Day 7, Day 14, Day 21, Day 28, Day 35, Day 65
|
SpO2 over time will be measured by pulse oximetry.
|
Day 1-Day 7, Day 14, Day 21, Day 28, Day 35, Day 65
|
IL-6
Time Frame: Through Day 65
|
Level of the inflammatory biomarker IL-6 in blood will be measured.
|
Through Day 65
|
TNF-alpha
Time Frame: Through Day 65
|
Level of the inflammatory biomarker TNF- alpha in blood will be measured.
|
Through Day 65
|
C-reactive protein
Time Frame: Through Day 65
|
Level of the inflammatory biomarker C-reactive protein in blood will be measured.
|
Through Day 65
|
Serum ferritin
Time Frame: Through Day 65
|
Level of serum ferritin in blood will be measured.
|
Through Day 65
|
D-dimer
Time Frame: Through Day 65
|
Level of D-dimer in blood will be measured.
|
Through Day 65
|
Serum concentration of ORTD-1 (Pharmacokinetics)
Time Frame: Day 1-Day 6, Day 14, Day 21, Day 35, Day 65
|
Serum concentration of ORTD-1 will be measured following IV infusion and during follow-up
|
Day 1-Day 6, Day 14, Day 21, Day 35, Day 65
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alpesh Amin, MD, Professor & Chair, Department of Medicine University of California, Irvine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2021
Primary Completion (Anticipated)
May 1, 2021
Study Completion (Anticipated)
July 1, 2021
Study Registration Dates
First Submitted
January 8, 2021
First Submitted That Met QC Criteria
January 12, 2021
First Posted (Actual)
January 13, 2021
Study Record Updates
Last Update Posted (Actual)
June 14, 2021
Last Update Submitted That Met QC Criteria
June 9, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORTD1-COV-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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