DAS181 for Severe COVID-19: Compassionate Use

May 1, 2020 updated by: Gong Zuojiong, Renmin Hospital of Wuhan University
The objective of the study is to investigate the safety and potential efficacy of DAS181 for the treatment of severe COVID-19.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China
        • Renmin Hospital of Wuhan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved clinical status
Time Frame: Day 14
Percent of subjects with improved clinical status
Day 14
Return to room air
Time Frame: Day 14
Percent of subjects return to room air
Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 RNA
Time Frame: 28 days
time to SARS-CoV-2 RNA in the respiratory specimens being undetectable
28 days
Discharge
Time Frame: Days 14, 21, 28
Percent of patients discharge from hospital
Days 14, 21, 28
Death
Time Frame: Day 14, 21, 28
All-cause mortality rate
Day 14, 21, 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renmin Hospital of Wuhan University

Collaborators

Ansun Biopharma, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 6, 2020

Primary Completion (ACTUAL)

April 16, 2020

Study Completion (ACTUAL)

April 30, 2020

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 25, 2020

First Posted (ACTUAL)

March 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2020

Last Update Submitted That Met QC Criteria

May 1, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAS181-SARS-CoV-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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