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

Withdrawn
COVID-19

Drug: ORTD-1 low dose

ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Other Name: Intervention 1

Drug: ORTD-1 mid dose

ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Other Name: Intervention 1

Drug: ORTD-1 high dose

ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Other Name: Intervention 1

Other: Vehicle control

Vehicle Control will be administered intravenously once daily for 5 consecutive days.
Other Name: Intervention 2

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

UC Irvine Medical Center
Orange, California, United States

Alpesh Amin, MD, Principal Investigator
Professor & Chair, Department of Medicine University of California, Irvine

Oryn Therapeutics, LLC
NCT Number
Keywords
COVID-19 pneumonia
SARS-CoV-2
COVID-19 drug treatment
theta-defensins
MeSH Terms
COVID-19
Pneumonia