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CompletedNCT04324489Updated May 5, 2020

DAS181 for Severe COVID-19: Compassionate Use

An interventional study of DAS181 in COVID-19, sponsored by Renmin Hospital of Wuhan University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-05-05.

Sponsored by Renmin Hospital of Wuhan University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • COVID-19

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Keywords

  • COVID-19
  • SARS-CoV-2
  • DAS181
  • Hypoxemia
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 4 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Renmin Hospital of Wuhan University is the lead sponsor of 83 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    DAS181 Treatment

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

    Drug: DAS181

Interventions

  • DrugDAS181

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

06

What researchers measure

Primary outcomes

  1. Improved clinical status

    Percent of subjects with improved clinical status

    Time frame: Day 14

  2. Return to room air

    Percent of subjects return to room air

    Time frame: Day 14

Secondary outcomes

  1. SARS-CoV-2 RNA

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

    Time frame: 28 days

  2. Discharge

    Percent of patients discharge from hospital

    Time frame: Days 14, 21, 28

  3. Death

    All-cause mortality rate

    Time frame: Day 14, 21, 28

07

Study locations

1 site
  • Renmin Hospital of Wuhan University
    Wuhan, Hubei, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04324489
Lead sponsor
Renmin Hospital of Wuhan University
Collaborators
Ansun Biopharma, Inc.
Responsible party
Gong Zuojiong (Director, Department of Infectious Disease, Renmin Hospital of Wuhan University) — Principal investigator
First posted
Mar 27, 2020
Start date
Mar 6, 2020
Primary completion
Apr 16, 2020
Completion
Apr 30, 2020
Last update
May 5, 2020

Study contacts

Zuojiong Gong, MD
principal investigator · Renmin Hospital of Wuhan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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