A Study of ORTD-1 in Patients Hospitalized With COVID-19 Related Pneumonia

Overview

Evaluate the safety and effect of ORTD-1 on COVID-19 related pneumonia.

Full Title of Study: “A Blinded, Controlled, Escalating Dose Study of ORTD-1 for Treatment of Hospitalized Patients With SARS-CoV-2 (COVID-19) Related Pneumonia.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2021

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.

Interventions

  • Drug: ORTD-1 low dose
    • ORTD-1 will be administered intravenously once daily for 5 consecutive days.
  • Drug: ORTD-1 mid dose
    • ORTD-1 will be administered intravenously once daily for 5 consecutive days.
  • Drug: ORTD-1 high dose
    • ORTD-1 will be administered intravenously once daily for 5 consecutive days.
  • Other: Vehicle control
    • Vehicle Control will be administered intravenously once daily for 5 consecutive days.

Arms, Groups and Cohorts

  • Experimental: ORTD-1 Low dose
    • Arm 1: ORTD-1
  • Experimental: ORTD-1 Mid Dose
    • Arm 2: ORTD-1
  • Experimental: ORTD-1 High Dose
    • Arm 3 : ORTD-1
  • Placebo Comparator: Vehicle Control
    • Arm 4: Vehicle control

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of adverse events
    • Time Frame: Through Day 65
    • Number of participants with treatment-emergent adverse events
  • Incidence of laboratory abnormalities
    • Time Frame: Through Day 65
    • Number of participants with Grade 3 or higher laboratory abnormalities
  • Incidence of anti-drug antibodies
    • Time Frame: Through Day 65
    • Number of participants who develop antibodies to ORTD-1

Secondary Measures

  • 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.
  • Percentage of days requiring supplemental oxygen
    • Time Frame: Day 1-65
    • Percentage of days for which the patient requires supplemental oxygen will be recorded.
  • Overall survival (OS)
    • Time Frame: Day 1-65
    • Overall survival is defined as the time from enrollment until death from any cause.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oryn Therapeutics, LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alpesh Amin, MD, Principal Investigator, Professor & Chair, Department of Medicine University of California, Irvine
  • Overall Contact(s)
    • Debbie Tranowski, B.S., 844-400-6796, dtranowski@oryntherapeutics.com

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