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DAS181 for Severe COVID-19: Compassionate Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04324489
Recruitment Status : Completed
First Posted : March 27, 2020
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
Ansun Biopharma, Inc.
Information provided by (Responsible Party):
Gong Zuojiong, Renmin Hospital of Wuhan University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 6, 2020
Actual Primary Completion Date : April 16, 2020
Actual Study Completion Date : April 30, 2020

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.




Primary Outcome Measures :
  1. Improved clinical status [ Time Frame: Day 14 ]
    Percent of subjects with improved clinical status

  2. Return to room air [ Time Frame: Day 14 ]
    Percent of subjects return to room air


Secondary Outcome Measures :
  1. SARS-CoV-2 RNA [ Time Frame: 28 days ]
    time to SARS-CoV-2 RNA in the respiratory specimens being undetectable

  2. Discharge [ Time Frame: Days 14, 21, 28 ]
    Percent of patients discharge from hospital

  3. Death [ Time Frame: Day 14, 21, 28 ]
    All-cause mortality rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04324489


Locations
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China, Hubei
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Sponsors and Collaborators
Renmin Hospital of Wuhan University
Ansun Biopharma, Inc.
Investigators
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Principal Investigator: Zuojiong Gong, MD Renmin Hospital of Wuhan University
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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: March 27, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Renmin Hospital of Wuhan University:
COVID-19
SARS-CoV-2
DAS181
Hypoxemia