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

Phase 1

Withdrawn

• Conditions: COVID-19
• Interventions: Other: Vehicle control; Drug: ORTD-1 low dose; Drug: ORTD-1 mid dose; Drug: ORTD-1 high dose

• Registration Number: NCT04708236
• Lead Sponsor: Oryn Therapeutics, LLC

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.

Study Timeline

• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-13
• Study Start: 2021-04
• Primary Completion: 2021-05
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-14
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Vehicle Control	Vehicle control	Arm 4: Vehicle control
ORTD-1 Low dose	ORTD-1 low dose	Arm 1: ORTD-1
ORTD-1 Mid Dose	ORTD-1 mid dose	Arm 2: ORTD-1
ORTD-1 High Dose	ORTD-1 high dose	Arm 3 : ORTD-1

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion of patients requiring intubation	Day 1-65	The requirement of intubation and invasive ventilation will be assessed for patients at each visit.
Overall survival (OS)	Day 1-65	Overall survival is defined as the time from enrollment until death from any cause.
Percentage of days requiring supplemental oxygen	Day 1-65	Percentage of days for which the patient requires supplemental oxygen will be recorded.

Trial Locations

Locations (1)

UC Irvine Medical Center; 🇺🇸 Orange, California, United States