DAS181 for STOP COVID-19
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|ClinicalTrials.gov Identifier: NCT04354389|
Recruitment Status : Withdrawn (No COVID-19 in EU countries - Sponsor withdraw in regulatory stage)
First Posted : April 21, 2020
Last Update Posted : August 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: DAS181 Drug: Placebo||Phase 2 Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||DAS181 for COVID-19: A Phase II Multicenter, Randomized, Placebo-Controlled, Double-Blind Study|
|Estimated Study Start Date :||July 25, 2020|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||November 30, 2020|
Experimental: DAS181 b.i.d.+ standard local care for COVID-19
4.5 mg DAS181 b.i.d nebulized inhalation for 10 consecutive days + standard local care for COVID-19
4.5 mg q.d.
Placebo Comparator: Placebo+ standard local care for COVID-19
nebulized inhalation for 10 consecutive days + standard local care for COVID-19
q.d. or b.i.d.
Experimental: DAS181 q.d.+ standard local care for COVID-19
4.5 mg placebo q.d. nebulized inhalation for 10 consecutive days + standard local care for COVID-19
4.5 mg b.i.d
- Percent of subjects return to room air (RTRA) [ Time Frame: Day 14 ]
- Percent of subjects who have recovered [ Time Frame: Day 5, 10, 14, 21, 28 ]Percent of subjects who reach level 1 of COVID-19 Clinical Classification (discharged or return to normal activity)
- Improved COVID-19 Clinical Classification [ Time Frame: Day 28 ]time to Improved COVID-19 Clinical Classification 1 to 6 (where higher score means worse outcome)
- Return To Room Air (RTRA) [ Time Frame: Day 10, 21, 28 ]Percent of subjects RTRA
- Percent of subjects who achieve clinical stability [ Time Frame: Day 28 ]
- SARS-CoV-2 RNA undetectable [ Time Frame: Day 28 ]Time to
- Clinical Deterioration [ Time Frame: Day 28 ]Time to
- Percent of subjects discharged [ Time Frame: Day 14, 21, 28 ]Percent of subjects discharge
- Death (all cause) [ Time Frame: Day 28 ]Time to
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354389
|Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico|
|A.O.U Policlinico Di Modena|
|Study Director:||Jennifer Ho, MD, PhD||Ansun Biopharma, Inc.|