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DAS181 for Severe COVID-19: Compassionate Use

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DAS181
Sponsored by
Renmin Hospital of Wuhan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, SARS-CoV-2, DAS181, Hypoxemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Renmin Hospital of Wuhan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DAS181 Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Improved clinical status
Percent of subjects with improved clinical status
Return to room air
Percent of subjects return to room air

Secondary Outcome Measures

SARS-CoV-2 RNA
time to SARS-CoV-2 RNA in the respiratory specimens being undetectable
Discharge
Percent of patients discharge from hospital
Death
All-cause mortality rate

Full Information

First Posted
March 25, 2020
Last Updated
May 1, 2020
Sponsor
Renmin Hospital of Wuhan University
Collaborators
Ansun Biopharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04324489
Brief Title
DAS181 for Severe COVID-19: Compassionate Use
Official Title
DAS181 for Severe COVID-19: Compassionate Use
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 6, 2020 (Actual)
Primary Completion Date
April 16, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Renmin Hospital of Wuhan University
Collaborators
Ansun Biopharma, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, SARS-CoV-2, DAS181, Hypoxemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DAS181 Treatment
Arm Type
Experimental
Arm Description
Nebulized DAS181 9mg/day (4.5 mg bid/day) for 10 days
Intervention Type
Drug
Intervention Name(s)
DAS181
Intervention Description
Patient receives nebulized DAS181 (4.5 mg BID/day, a total 9 mg/day) for 10 days.
Primary Outcome Measure Information:
Title
Improved clinical status
Description
Percent of subjects with improved clinical status
Time Frame
Day 14
Title
Return to room air
Description
Percent of subjects return to room air
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
SARS-CoV-2 RNA
Description
time to SARS-CoV-2 RNA in the respiratory specimens being undetectable
Time Frame
28 days
Title
Discharge
Description
Percent of patients discharge from hospital
Time Frame
Days 14, 21, 28
Title
Death
Description
All-cause mortality rate
Time Frame
Day 14, 21, 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Positive for RNA of SARS-CoV-2 from respiratory specimens or blood specimens Hypoxemic Severe COVID-19 If female, subject must not be pregnant or nursing. Non-vasectomized males are required to practice effective birth control methods 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: ALT or AST> 8 x ULN (ALT or AST> 3 x ULN) and (Total bilirubin> 2.5 x ULN or INR> 2.0 x ULN) Female subjects who have a positive pregnancy test and are breastfeeding Subjects using any other investigational antiviral drugs during the hospitalization before enrollment. Subjects participating in other clinical trials Subjects may be transferred to a non-participating hospital within 72 hours People who cannot cooperate well due to mental illness, have no self-control, and cannot express clearly Severe underlying diseases affecting survival Critical COVID-19 requiring mechanical ventilator at the time enrolled
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zuojiong Gong, MD
Organizational Affiliation
Renmin Hospital of Wuhan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

DAS181 for Severe COVID-19: Compassionate Use

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