COVID-19
Conditions
Keywords
COVID-19, SARS-CoV-2, DAS181, Hypoxemia
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 (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.
Interventions
DRUGDAS181
Patient receives nebulized DAS181 (4.5 mg BID/day, a total 9 mg/day) for 10 days.
Sponsors
Ansun Biopharma, Inc.
Renmin Hospital of Wuhan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Positive for RNA of SARS-CoV-2 from respiratory specimens or blood specimens 2. Hypoxemic 3. Severe COVID-19 4. If female, subject must not be pregnant or nursing. 5. Non-vasectomized males are required to practice effective birth control methods 6. 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 criteria
1. ALT or AST\> 8 x ULN 2. (ALT or AST\> 3 x ULN) and (Total bilirubin\> 2.5 x ULN or INR\> 2.0 x ULN) 3. Female subjects who have a positive pregnancy test and are breastfeeding 4. Subjects using any other investigational antiviral drugs during the hospitalization before enrollment. 5. Subjects participating in other clinical trials 6. Subjects may be transferred to a non-participating hospital within 72 hours 7. People who cannot cooperate well due to mental illness, have no self-control, and cannot express clearly 8. Severe underlying diseases affecting survival 9. Critical COVID-19 requiring mechanical ventilator at the time enrolled
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improved clinical status | Day 14 | Percent of subjects with improved clinical status |
| Return to room air | Day 14 | Percent of subjects return to room air |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SARS-CoV-2 RNA | 28 days | time to SARS-CoV-2 RNA in the respiratory specimens being undetectable |
| Discharge | Days 14, 21, 28 | Percent of patients discharge from hospital |
| Death | Day 14, 21, 28 | All-cause mortality rate |
Countries
China
Outcome results
None listed