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.
Drug: ORTD-1 low dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Other Name: Intervention 1
Drug: ORTD-1 mid dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Other Name: Intervention 1
Drug: ORTD-1 high dose
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
Other Name: Intervention 1
Other: Vehicle control
Vehicle Control will be administered intravenously once daily for 5 consecutive days.
Other Name: Intervention 2
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
UC Irvine Medical Center
Orange, California, United States
Alpesh Amin, MD, Principal Investigator
Professor & Chair, Department of Medicine University of California, Irvine