DAS181 for Severe COVID-19: Compassionate Use

NCT ID: NCT04324489

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-06
• Study Completion Date: 2020-04-30

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.

Conditions

COVID-19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DAS181 Treatment

Nebulized DAS181 9mg/day (4.5 mg bid/day) for 10 days

Group Type: EXPERIMENTAL

DAS181

Intervention Type: DRUG

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

Interventions

DAS181

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ansun Biopharma, Inc.

INDUSTRY

Sponsor Role: collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Gong Zuojiong

Director, Department of Infectious Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zuojiong Gong, MD

Role: PRINCIPAL_INVESTIGATOR

Renmin Hospital of Wuhan University

Locations

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Countries

China

Other Identifiers

DAS181-SARS-CoV-2

Identifier Type: -

Identifier Source: org_study_id