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

Purpose

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

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention 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.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04708236
Status
Withdrawn
Sponsor
Oryn Therapeutics, LLC

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.