It is a multicenter, randomized, placebo-controlled, double-blind study. The study population is defined as subjects diagnosed with lower respiratory tract COVID-19 who require supplemental oxygen ≥2 LPM at the time of randomization.
The first stage is randomized, double-blind study to confirm the optimal dose of the study. Twenty-two (n=22) subjects with COVID-19 and clinically significant impairment of respiratory function will be enrolled to evaluate the two dosing regimens (4.5mg-q.d or 4.5mg-b.i.d) of DAS181. At the end of Stage 1, the Sponsor will evaluate the dose regimen based on the safety and efficacy assessments of the data. An optimal dose will be selected to proceed to Stage 2. The second stage is a randomized, placebo-controlled and double-blind study to expand enrollment with an additional eighty-two (n=82) subjects to provide adequate power to potentially demonstrate statistically significant therapeutic efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, Italy
A.O.U Policlinico Di Modena
Modena, Italy
Percent of subjects return to room air (RTRA)
Time frame: Day 14
Percent of subjects who have recovered
Percent of subjects who reach level 1 of COVID-19 Clinical Classification (discharged or return to normal activity)
Time frame: Day 5, 10, 14, 21, 28
Improved COVID-19 Clinical Classification
time to Improved COVID-19 Clinical Classification 1 to 6 (where higher score means worse outcome)
Time frame: Day 28
Return To Room Air (RTRA)
Percent of subjects RTRA
Time frame: Day 10, 21, 28
Percent of subjects who achieve clinical stability
Time frame: Day 28
SARS-CoV-2 RNA undetectable
Time to
Time frame: Day 28
Clinical Deterioration
Time to
Time frame: Day 28
Percent of subjects discharged
Percent of subjects discharge
Time frame: Day 14, 21, 28
Death (all cause)
Time to
Time frame: Day 28
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