Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
estimated completion
Principal Investigator
by Alpesh Amin, MD

Description

Summary

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

Official Title

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

Details

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.

Keywords

COVID-19 COVID-19 pneumonia SARS-CoV-2 COVID-19 drug treatment theta-defensins Pneumonia ORTD-1 low dose ORTD-1 mid dose ORTD-1 high dose

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • UC Irvine Medical Center accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Alpesh Amin, MD
    Clinical Professor, Medicine. Authored (or co-authored) 214 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Oryn Therapeutics, LLC
ID
NCT04708236
Phase
Phase 1/2
Study Type
Interventional
Last Updated