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Purpose

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

Condition

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Withdrawn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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.