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recruitment
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Evaluate the safety and effect of ORTD-1 on COVID-19 related pneumonia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORTD-1 Low dose | Experimental | Arm 1: ORTD-1 |
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| ORTD-1 Mid Dose | Experimental | Arm 2: ORTD-1 |
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| ORTD-1 High Dose | Experimental | Arm 3 : ORTD-1 |
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| Vehicle Control | Placebo Comparator | Arm 4: Vehicle control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORTD-1 low dose | Drug | ORTD-1 will be administered intravenously once daily for 5 consecutive days. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral blood oxygen levels (SpO2) | SpO2 over time will be measured by pulse oximetry. | Day 1-Day 7, Day 14, Day 21, Day 28, Day 35, Day 65 |
| IL-6 | Level of the inflammatory biomarker IL-6 in blood will be measured. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alpesh Amin, MD | Professor & Chair, Department of Medicine University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine Medical Center | Orange | California | 92868 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000713949 | rhesus-theta-defensin-1 |
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Patients will be allocated into 1 of 3 sequential escalating dose cohorts and randomized to ORTD-1 treatment versus vehicle control within each cohort.
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| ORTD-1 mid dose | Drug | ORTD-1 will be administered intravenously once daily for 5 consecutive days. |
|
|
| ORTD-1 high dose | Drug | ORTD-1 will be administered intravenously once daily for 5 consecutive days. |
|
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| Vehicle control | Other | Vehicle Control will be administered intravenously once daily for 5 consecutive days. |
|
|
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 |
| Through Day 65 |
| TNF-alpha | Level of the inflammatory biomarker TNF- alpha in blood will be measured. | Through Day 65 |
| C-reactive protein | Level of the inflammatory biomarker C-reactive protein in blood will be measured. | Through Day 65 |
| Serum ferritin | Level of serum ferritin in blood will be measured. | Through Day 65 |
| D-dimer | Level of D-dimer in blood will be measured. | Through Day 65 |
| Serum concentration of ORTD-1 (Pharmacokinetics) | Serum concentration of ORTD-1 will be measured following IV infusion and during follow-up | Day 1-Day 6, Day 14, Day 21, Day 35, Day 65 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |