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

Study Overview
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Brief Summary
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Evaluate the safety and effect of ORTD-1 on COVID-19 related pneumonia.

Detailed Description
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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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: ORTD-1 low dose
* Drug: ORTD-1 mid dose
* Drug: ORTD-1 high dose
* Other: Vehicle control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ORTD-1 Low dose<br>Arm 1: ORTD-1 | Drug: ORTD-1 low dose<br>* ORTD-1 will be administered intravenously once daily for 5 consecutive days.<br>* Other names: Intervention 1;|
| Experimental: ORTD-1 Mid Dose<br>Arm 2: ORTD-1 | Drug: ORTD-1 mid dose<br>* ORTD-1 will be administered intravenously once daily for 5 consecutive days.<br>* Other names: Intervention 1;|
| Experimental: ORTD-1 High Dose<br>Arm 3 : ORTD-1 | Drug: ORTD-1 high dose<br>* ORTD-1 will be administered intravenously once daily for 5 consecutive days.<br>* Other names: Intervention 1;|
| Placebo Comparator: Vehicle Control<br>Arm 4: Vehicle control | Other: Vehicle control<br>* Vehicle Control will be administered intravenously once daily for 5 consecutive days.<br>* Other names: Intervention 2;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 pneumonia, SARS-CoV-2, COVID-19 drug treatment, theta-defensins