DAS181 for Severe COVID-19: Compassionate Use

COVID-19 Clinical Trial

Official title:

DAS181 for Severe COVID-19: Compassionate Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04324489
• Other study ID #: DAS181-SARS-CoV-2
• Status: Completed
• Phase: N/A
• Start date: March 6, 2020
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2020
• Source: Renmin Hospital of Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to investigate the safety and potential efficacy of DAS181 for the treatment of severe COVID-19.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: April 30, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• DAS181
Patient receives nebulized DAS181 (4.5 mg BID/day, a total 9 mg/day) for 10 days.

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University	Ansun Biopharma, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved clinical status	Percent of subjects with improved clinical status	Day 14
Primary	Return to room air	Percent of subjects return to room air	Day 14
Secondary	SARS-CoV-2 RNA	time to SARS-CoV-2 RNA in the respiratory specimens being undetectable	28 days
Secondary	Discharge	Percent of patients discharge from hospital	Days 14, 21, 28
Secondary	Death	All-cause mortality rate	Day 14, 21, 28