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

Sponsor

Oryn Therapeutics, LLC (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04708236

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: ORTD-1 low dose Drug: ORTD-1 mid dose Drug: ORTD-1 high dose Other: Vehicle control	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

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.Patients will be allocated into 1 of 3 sequential escalating dose cohorts and randomized to ORTD-1 treatment versus vehicle control within each cohort.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

May 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Peripheral blood oxygen levels (SpO2) [Day 1-Day 7, Day 14, Day 21, Day 28, Day 35, Day 65]
SpO2 over time will be measured by pulse oximetry.
IL-6 [Through Day 65]
Level of the inflammatory biomarker IL-6 in blood will be measured.
TNF-alpha [Through Day 65]
Level of the inflammatory biomarker TNF- alpha in blood will be measured.
C-reactive protein [Through Day 65]
Level of the inflammatory biomarker C-reactive protein in blood will be measured.
Serum ferritin [Through Day 65]
Level of serum ferritin in blood will be measured.
D-dimer [Through Day 65]
Level of D-dimer in blood will be measured.
Serum concentration of ORTD-1 (Pharmacokinetics) [Day 1-Day 6, Day 14, Day 21, Day 35, Day 65]
Serum concentration of ORTD-1 will be measured following IV infusion and during follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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