Status:
COMPLETED
DAS181 for Severe COVID-19: Compassionate Use
Lead Sponsor:
Renmin Hospital of Wuhan University
Collaborating Sponsors:
Ansun Biopharma, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The objective of the study is to investigate the safety and potential efficacy of DAS181 for the treatment of severe COVID-19.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Key
- Positive for RNA of SARS-CoV-2 from respiratory specimens or blood specimens
- Hypoxemic
- Severe COVID-19
- If female, subject must not be pregnant or nursing.
- Non-vasectomized males are required to practice effective birth control methods
- Capable of understanding and complying with procedures as outlined in the protocol as judged by the Investigator and able to sign informed consent form prior to the initiation of any screening or study-specific procedures.
Exclusion
- ALT or AST\> 8 x ULN
- (ALT or AST\> 3 x ULN) and (Total bilirubin\> 2.5 x ULN or INR\> 2.0 x ULN)
- Female subjects who have a positive pregnancy test and are breastfeeding
- Subjects using any other investigational antiviral drugs during the hospitalization before enrollment.
- Subjects participating in other clinical trials
- Subjects may be transferred to a non-participating hospital within 72 hours
- People who cannot cooperate well due to mental illness, have no self-control, and cannot express clearly
- Severe underlying diseases affecting survival
- Critical COVID-19 requiring mechanical ventilator at the time enrolled
Key Trial Info
Start Date :
March 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04324489
Start Date
March 6 2020
End Date
April 30 2020
Last Update
May 5 2020
Active Locations (1)
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1
Renmin Hospital of Wuhan University
Wuhan, Hubei, China