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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
ORTD-1 will be administered intravenously once daily for 5 consecutive days.
UC Irvine Medical Center
Orange, California, United States
Incidence of adverse events
Number of participants with treatment-emergent adverse events
Time frame: Through Day 65
Incidence of laboratory abnormalities
Number of participants with Grade 3 or higher laboratory abnormalities
Time frame: Through Day 65
Incidence of anti-drug antibodies
Number of participants who develop antibodies to ORTD-1
Time frame: Through Day 65
Proportion of patients requiring intubation
The requirement of intubation and invasive ventilation will be assessed for patients at each visit.
Time frame: Day 1-65
Percentage of days requiring supplemental oxygen
Percentage of days for which the patient requires supplemental oxygen will be recorded.
Time frame: Day 1-65
Overall survival (OS)
Overall survival is defined as the time from enrollment until death from any cause.
Time frame: Day 1-65
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Vehicle Control will be administered intravenously once daily for 5 consecutive days.