NCT04354389

DAS181 for STOP COVID-19

DAS181 for COVID-19: A Phase II Multicenter, Randomized, Placebo-Controlled, Double-Blind Study

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ansun Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	DAS181	4.5 mg b.i.d
DRUG	Placebo	q.d. or b.i.d.
DRUG	DAS181	4.5 mg q.d.

Timeline

• Start date: 2020-07-25
• Primary completion: 2020-09-30
• Completion: 2020-11-30
• First posted: 2020-04-21
• Last updated: 2020-08-11

Locations

2 sites across 1 country: Italy

Regulatory

• FDA-regulated drug study