DAS181 for Severe COVID-19: Compassionate Use

• Sponsor: Renmin Hospital of Wuhan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04324489
• Collaborator: Ansun Biopharma, Inc. (Industry)
• Enrollment: 4
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.8
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: DAS181	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: DAS181 for Severe COVID-19: Compassionate Use
• Actual Study Start Date: Mar 6, 2020
• Actual Primary Completion Date: Apr 16, 2020
• Actual Study Completion Date: Apr 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DAS181 Treatment Nebulized DAS181 9mg/day (4.5 mg bid/day) for 10 days	Drug: DAS181; Patient receives nebulized DAS181 (4.5 mg BID/day, a total 9 mg/day) for 10 days.

Outcome Measures

Primary Outcome Measures

1. Improved clinical status [Day 14]

   Percent of subjects with improved clinical status

2. Return to room air [Day 14]

   Percent of subjects return to room air

Secondary Outcome Measures

1. SARS-CoV-2 RNA [28 days]

   time to SARS-CoV-2 RNA in the respiratory specimens being undetectable

2. Discharge [Days 14, 21, 28]

   Percent of patients discharge from hospital

3. Death [Day 14, 21, 28]

   All-cause mortality rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renmin Hospital of Wuhan University	Wuhan	Hubei	China

Sponsors and Collaborators

• Renmin Hospital of Wuhan University
• Ansun Biopharma, Inc.

Investigators

• Principal Investigator: Zuojiong Gong, MD, Renmin Hospital of Wuhan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gong Zuojiong, Director, Department of Infectious Disease, Renmin Hospital of Wuhan University
• ClinicalTrials.gov Identifier: NCT04324489
• Other Study ID Numbers: DAS181-SARS-CoV-2
• First Posted: Mar 27, 2020
• Last Update Posted: May 5, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Gong Zuojiong, Director, Department of Infectious Disease, Renmin Hospital of Wuhan University: COVID-19; SARS-CoV-2; DAS181; Hypoxemia
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of May 5, 2020