Back to resultsA Study of ORTD-1 in Patients Hospitalized With COVID-19 Related Pneumonia
Primary Purpose
COVID-19
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ORTD-1 low dose
ORTD-1 mid dose
ORTD-1 high dose
Vehicle control
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19 pneumonia, SARS-CoV-2, COVID-19 drug treatment, theta-defensins
Eligibility Criteria
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
Sites / Locations
- UC Irvine Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
ORTD-1 Low dose
ORTD-1 Mid Dose
ORTD-1 High Dose
Vehicle Control
Arm Description
Arm 1: ORTD-1
Arm 2: ORTD-1
Arm 3 : ORTD-1
Arm 4: Vehicle control
Outcomes
Primary Outcome Measures
Incidence of adverse events
Number of participants with treatment-emergent adverse events
Incidence of laboratory abnormalities
Number of participants with Grade 3 or higher laboratory abnormalities
Incidence of anti-drug antibodies
Number of participants who develop antibodies to ORTD-1
Secondary Outcome Measures
Proportion of patients requiring intubation
The requirement of intubation and invasive ventilation will be assessed for patients at each visit.
Percentage of days requiring supplemental oxygen
Percentage of days for which the patient requires supplemental oxygen will be recorded.
Overall survival (OS)
Overall survival is defined as the time from enrollment until death from any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04708236
Brief Title
A Study of ORTD-1 in Patients Hospitalized With COVID-19 Related Pneumonia
Official Title
A Blinded, Controlled, Escalating Dose Study of ORTD-1 for Treatment of Hospitalized Patients With SARS-CoV-2 (COVID-19) Related Pneumonia.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
recruitment
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oryn Therapeutics, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19 pneumonia, SARS-CoV-2, COVID-19 drug treatment, theta-defensins
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Patients will be allocated into 1 of 3 sequential escalating dose cohorts and randomized to ORTD-1 treatment versus vehicle control within each cohort.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ORTD-1 Low dose
Arm Type
Experimental
Arm Description
Arm 1: ORTD-1
Arm Title
ORTD-1 Mid Dose
Arm Type
Experimental
Arm Description
Arm 2: ORTD-1
Arm Title
ORTD-1 High Dose
Arm Type
Experimental
Arm Description
Arm 3 : ORTD-1
Arm Title
Vehicle Control
Arm Type
Placebo Comparator
Arm Description
Arm 4: Vehicle control
Intervention Type
Drug
Intervention Name(s)
ORTD-1 low dose
Other Intervention Name(s)
Intervention 1
Intervention Description
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Intervention Type
Drug
Intervention Name(s)
ORTD-1 mid dose
Other Intervention Name(s)
Intervention 1
Intervention Description
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Intervention Type
Drug
Intervention Name(s)
ORTD-1 high dose
Other Intervention Name(s)
Intervention 1
Intervention Description
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Intervention Type
Other
Intervention Name(s)
Vehicle control
Other Intervention Name(s)
Intervention 2
Intervention Description
Vehicle Control will be administered intravenously once daily for 5 consecutive days.
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Number of participants with treatment-emergent adverse events
Time Frame
Through Day 65
Title
Incidence of laboratory abnormalities
Description
Number of participants with Grade 3 or higher laboratory abnormalities
Time Frame
Through Day 65
Title
Incidence of anti-drug antibodies
Description
Number of participants who develop antibodies to ORTD-1
Time Frame
Through Day 65
Secondary Outcome Measure Information:
Title
Proportion of patients requiring intubation
Description
The requirement of intubation and invasive ventilation will be assessed for patients at each visit.
Time Frame
Day 1-65
Title
Percentage of days requiring supplemental oxygen
Description
Percentage of days for which the patient requires supplemental oxygen will be recorded.
Time Frame
Day 1-65
Title
Overall survival (OS)
Description
Overall survival is defined as the time from enrollment until death from any cause.
Time Frame
Day 1-65
Other Pre-specified Outcome Measures:
Title
Peripheral blood oxygen levels (SpO2)
Description
SpO2 over time will be measured by pulse oximetry.
Time Frame
Day 1-Day 7, Day 14, Day 21, Day 28, Day 35, Day 65
Title
IL-6
Description
Level of the inflammatory biomarker IL-6 in blood will be measured.
Time Frame
Through Day 65
Title
TNF-alpha
Description
Level of the inflammatory biomarker TNF- alpha in blood will be measured.
Time Frame
Through Day 65
Title
C-reactive protein
Description
Level of the inflammatory biomarker C-reactive protein in blood will be measured.
Time Frame
Through Day 65
Title
Serum ferritin
Description
Level of serum ferritin in blood will be measured.
Time Frame
Through Day 65
Title
D-dimer
Description
Level of D-dimer in blood will be measured.
Time Frame
Through Day 65
Title
Serum concentration of ORTD-1 (Pharmacokinetics)
Description
Serum concentration of ORTD-1 will be measured following IV infusion and during follow-up
Time Frame
Day 1-Day 6, Day 14, Day 21, Day 35, Day 65
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alpesh Amin, MD
Organizational Affiliation
Professor & Chair, Department of Medicine University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of ORTD-1 in Patients Hospitalized With COVID-19 Related Pneumonia
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