COVID-19
Conditions
Keywords
COVID-19 pneumonia, SARS-CoV-2, COVID-19 drug treatment, theta-defensins
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.
Interventions
DRUGORTD-1 low dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
DRUGORTD-1 mid dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
DRUGORTD-1 high dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
OTHERVehicle control
Vehicle Control will be administered intravenously once daily for 5 consecutive days.
Sponsors
Oryn Therapeutics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
Countries
United States
Outcome results
None listed