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Withdrawn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

  • United States
    • 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
Drug: ORTD-1 low dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Other Names:
  • Intervention 1
Experimental: ORTD-1 Mid Dose
Arm 2: ORTD-1
Drug: ORTD-1 mid dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Other Names:
  • Intervention 1
Experimental: ORTD-1 High Dose
Arm 3 : ORTD-1
Drug: ORTD-1 high dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Other Names:
  • Intervention 1
Placebo Comparator: Vehicle Control
Arm 4: Vehicle control
Other: Vehicle control
Vehicle Control will be administered intravenously once daily for 5 consecutive days.
Other Names:
  • Intervention 2

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

Oryn Therapeutics, LLC

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

Keywords

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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