DAS181 for Severe COVID-19: Compassionate Use
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|ClinicalTrials.gov Identifier: NCT04324489|
Recruitment Status : Completed
First Posted : March 27, 2020
Last Update Posted : May 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: DAS181||Not Applicable|
Each eligible subject is treated with DAS181 for 10 days and observed for 28 days from the first day of administration.
From day 1 to 10, once or twice a day, for 10 consecutive days, a total of 9 mg (7 ml) nebulized DAS181 is given. If DAS181 is given by twice a day, one vial containing 4.5 mg (3.5m1) DAS181 should be delivered with about 12-hour interval.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||DAS181 for Severe COVID-19: Compassionate Use|
|Actual Study Start Date :||March 6, 2020|
|Actual Primary Completion Date :||April 16, 2020|
|Actual Study Completion Date :||April 30, 2020|
Experimental: DAS181 Treatment
Nebulized DAS181 9mg/day (4.5 mg bid/day) for 10 days
Patient receives nebulized DAS181 (4.5 mg BID/day, a total 9 mg/day) for 10 days.
- Improved clinical status [ Time Frame: Day 14 ]Percent of subjects with improved clinical status
- Return to room air [ Time Frame: Day 14 ]Percent of subjects return to room air
- SARS-CoV-2 RNA [ Time Frame: 28 days ]time to SARS-CoV-2 RNA in the respiratory specimens being undetectable
- Discharge [ Time Frame: Days 14, 21, 28 ]Percent of patients discharge from hospital
- Death [ Time Frame: Day 14, 21, 28 ]All-cause mortality rate
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): NCT04324489
|Renmin Hospital of Wuhan University|
|Wuhan, Hubei, China|
|Principal Investigator:||Zuojiong Gong, MD||Renmin Hospital of Wuhan University|