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DAS181 for Severe COVID-19: Compassionate Use

Trial Profile

DAS181 for Severe COVID-19: Compassionate Use

Status: Completed
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 06 May 2020

At a glance

  • Drugs DAS 181 (Primary)
  • Indications COVID 2019 infections
  • Focus Expanded access; Therapeutic Use
  • Most Recent Events

    • 01 May 2020 Status changed from recruiting to completed.
    • 02 Apr 2020 According to an Ansun Biopharma Media Release, in the first 14 days, the first two patients no longer required supplemental oxygen, and showed stabilized vital signs, increased oxygen saturation, and resolution of infiltrates on chest CT scans. The third patient, who had been a persistent SARS-CoV-2 carrier for more than 33 days, was completely virus-free before the end of the 10-day DAS181 regimen and met all discharge criteria, and the fourth is currently undergoing treatment.
    • 02 Apr 2020 According to an Ansun Biopharma Media Release, Dr. Ke Hu is the principal investigator.

Trial Overview

Purpose

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

Primary Endpoints

Improved clinical status

description: Percent of subjects with improved clinical status
time_frame: Day 14

Return to room air

description: Percent of subjects return to room air
time_frame: Day 14

Other Endpoints

SARS-CoV-2 RNA

description: time to SARS-CoV-2 RNA in the respiratory specimens being undetectable
time_frame: 28 days

Discharge

description: Percent of patients discharge from hospital
time_frame: Days 14, 21, 28

Death

description: All-cause mortality rate
time_frame: Day 14, 21, 28 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 4

    Actual: 4

  • Sex male & female
  • Age Group 18-70 years; adult; elderly

Patient Inclusion Criteria

Key 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.

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04324489 ClinicalTrials.gov: US National Institutes of Health
DAS181SARS-CoV2 -

Organisations

  • Affiliations Ansun Biopharma

Trial Dates

  • Initiation Dates

    Actual : 06 Mar 2020

  • Primary Completion Dates

    Planned : 25 Apr 2020

    Actual : 16 Apr 2020

  • End Dates

    Planned : 30 Apr 2020

    Actual : 30 Apr 2020

Other Details

  • Design open; prospective
  • Phase of Trial Clinical Phase Unknown
  • Location China
  • Focus Expanded access; Therapeutic Use

Interventions

Drugs Route Formulation
DAS 181Primary Drug Inhalation Powder

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.)

Results

Therapeutic efficacy

Preliminary results from an investigator-initiated programme in four evaluable patients showcased that the first two patients precluded the need for supplemental oxygen while displaying stabilised vital signs, enhanced oxygen saturation and infiltrate resolution, as apparent from chest CT scans. The third patient, who was a persistent SARS-CoV-2 carrier for more than 33 days, was completely relieved of the virus, before the end of the 10th day drug regimen, meeting all discharge criteria. The fourth patient was undergoing treatment and exhibiting positive trends [2] .
2020-04-08 11:06:33.517

Publications

  1. Ansun Biopharma. Ansun Biopharma Announces Positive Results from Investigator-Initiated Trial of Novel COVID-19 Treatment. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Ansun Biopharma 1 1 1

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Kejx Hu, MD
027-88999120
hukejx@163.com
show details
-
Zuojiong Gong, MD
027-88999120
zjgong@163.com
show details
Renmin Hospital of Wuhan University China
Zuojiong Guong, MD Renmin Hospital of Wuhan University China

Centres

Centre Name Location Trial Centre Country
-
-
-
Ansun Biopharma, Inc.
-
-
Renmin Hospital of Wuhan University
-
-
Renmin Hospital of Wuhan University Wuhan, Hubei China

Trial History

Event Date Event Type Comment
06 May 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 06 May 2020
01 May 2020 Status change - completed Status changed from recruiting to completed. Updated 06 May 2020
02 Apr 2020 Other trial event According to an Ansun Biopharma Media Release, in the first 14 days, the first two patients no longer required supplemental oxygen, and showed stabilized vital signs, increased oxygen saturation, and resolution of infiltrates on chest CT scans. The third patient, who had been a persistent SARS-CoV-2 carrier for more than 33 days, was completely virus-free before the end of the 10-day DAS181 regimen and met all discharge criteria, and the fourth is currently undergoing treatment. Updated 06 Apr 2020
02 Apr 2020 Other trial event According to an Ansun Biopharma Media Release, Dr. Ke Hu is the principal investigator. Updated 06 Apr 2020
02 Apr 2020 Results Results published in the Ansun Biopharma Media Release. Updated 06 Apr 2020
30 Mar 2020 New trial record New trial record Updated 30 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Ansun Biopharma. Ansun Biopharma Announces Positive Results from Investigator-Initiated Trial of Novel COVID-19 Treatment. Media-Rel 2020;.

    Media Release
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