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DAS181 for COVID-19: A Phase II/III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study

Trial Profile

DAS181 for COVID-19: A Phase II/III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 12 May 2020

At a glance

  • Drugs DAS 181 (Primary)
  • Indications COVID 2019 infections; Severe acute respiratory syndrome
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Ansun Biopharma
  • Most Recent Events

    • 07 May 2020 Planned End Date changed from 31 Jul 2020 to 31 Oct 2020.
    • 15 Apr 2020 According to an Ansun Biopharma media release, the first stage of this study is expected to enroll 22 patients from approximately twelve sites across the United States. After an interim review of the data, the company plans to initiate a second stage of this adaptive design trial, enrolling approximately 60 more patients in the US and Europe.
    • 15 Apr 2020 According to an Ansun Biopharma media release, the company today announced the enrollment of the first patient in this proof-of-concept study to evaluate the safety and efficacy of DAS181, the Companys investigational recombinant sialidase for the treatment of severe COVID-19 infection.

Trial Overview

Purpose

It is a multicenter, randomized, placebo-controlled, double-blind study. The study population is defined as subjects diagnosed with lower respiratory tract COVID-19 who require supplemental oxygen ≥2 LPM at the time of randomization.

Primary Endpoints

COVID-19 Clinical Classification (CCC)

description: Percent of subjects improved (1 to 6 where higher score means worse outcome)
time_frame: Day 14

Return to room air (RTRA)

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

Other Endpoints

Improved COVID-19 Clinical Classification

description: time to Improved COVID-19 Clinical Classification 1 to 6 (where higher score means worse outcome)
time_frame: Day 28

Return To Room Air (RTRA)

description: Percent of subjects RTRA
time_frame: Day 10, 21, 28

Death (all cause)

description: Time to
time_frame: Day 28

SARS-CoV-2 RNA undetectable

description: Time to
time_frame: Day 28

Percent of subjects discharged

description: Percent of subjects discharge
time_frame: Day 14, 21, 28

Clinical Deterioration

description: Time to
time_frame: Day 28 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Severe acute respiratory syndrome treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 82

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient Inclusion Criteria

1. Be ≥18 years of age 2. Provide adequate medical history to permit accurate stratification by health status 3. Prior to SARS CoV 2 infection, has no chronic or recurring requirement for supplemental oxygen 4. Have lower respiratory tract infection (LRTI) confirmed by imaging 5. Has laboratory-confirmation of the presence of SARS-CoV-2 in the respiratory tract 6. 6. At the time of randomization, requires supplemental oxygen ≥2 LPM for treatment of hypoxia or pulmonary stress as evidenced by at least one of the following: 1. Respiratory rate ≥ 30 breaths/min 2. SpO2 ≤93% at rest 3. PaO2/FiO2≤300 mmHg 4. Showing the progression of lung lesions within 24 to 48h by >50% 7. If female, subject must meet one of the following conditions: 1. Not be of childbearing potential or 2. Be of childbearing potential and have a negative urine/serum pregnancy test and agrees to practice an acceptable method of contraception 8. Non-vasectomized males are required to practice effective birth control methods 9. Capable of understanding and complying with procedures as outlined in the protocol 10. Provides signed informed consent prior to the initiation of any screening or study-specific procedures

Patient Exclusion Criteria

1. Subjects currently requiring mechanical, Bi-PAP or CPAP ventilation at randomization. 2. Subjects currently receiving any other investigational drug, as part of a clinical trial or under emergency approval for SARS-CoV-2 3. Subjects who are known asthmatic patients or HIV-positive 4. Subjects who are currently receiving inhaled biologics or anti-viral agents 5. Subjects with severe sepsis due to either their SARS-CoV-2 infection or a concurrent viral, bacterial, or fungal infection with vital organ failure or required vasopressors to maintain blood pressure 6. Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2xULN 7. Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug. 8. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance. 9. Subjects with known hypersensitivity to DAS181 and/or any of its components.

Trial Details

Identifiers

Identifier Owner
NCT04354389 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001874-30 European Clinical Trials Database
DAS181-3-02EU -

Organisations

  • Sponsors Ansun Biopharma
  • Affiliations Ansun Biopharma

Trial Dates

  • Initiation Dates

    Planned : 25 May 2020

  • Primary Completion Dates

    Planned : 30 Jun 2020

  • End Dates

    Planned : 31 Oct 2020

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase II/III
  • Location Europe; Italy; USA
  • Focus Proof of concept; Therapeutic Use

Interventions

Drugs Route Formulation
DAS 181Primary Drug Inhalation Powder

DAS181+ standard local care for COVID-19

4.5 mg DAS181 b.i.d nebulized inhalation for 10 consecutive days + standard local care for COVID-19
Drug: DAS181 (4.5 mg b.i.d)

Placebo+ standard local care for COVID-19

4.5 mg placebo b.i.d nebulized inhalation for 10 consecutive days + standard local care for COVID-19
Drug: Placebo (4.5 mg b.i.d)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Andrea Gori Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Italy
Cristina Mussini A.O.U Policlinico Di Modena Italy
Liz Dewaghe
858-452-2631 Ext: 155
eslaven@ansunbiopharma.com
show details
-
Sylvie Lu
858-452-2631 Ext: 199
slu-hinh@ansunbiopharma.com
show details
-

Centres

Centre Name Location Trial Centre Country
-
-
-
A.O.U Policlinico Di Modena Modena Italy
Ansun Biopharma
-
-
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano Italy

Trial History

Event Date Event Type Comment
12 May 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 12 May 2020
07 May 2020 Completion date Planned End Date changed from 31 Jul 2020 to 31 Oct 2020. Updated 12 May 2020
23 Apr 2020 Other trial event New source identified and integrated ClinicalTrials.gov: (US National Institutes of Health: NCT04354389). Updated 23 Apr 2020
15 Apr 2020 Other trial event According to an Ansun Biopharma media release, the first stage of this study is expected to enroll 22 patients from approximately twelve sites across the United States. After an interim review of the data, the company plans to initiate a second stage of this adaptive design trial, enrolling approximately 60 more patients in the US and Europe. Updated 17 Apr 2020
15 Apr 2020 Other trial event According to an Ansun Biopharma media release, the company today announced the enrollment of the first patient in this proof-of-concept study to evaluate the safety and efficacy of DAS181, the Companys investigational recombinant sialidase for the treatment of severe COVID-19 infection. Updated 17 Apr 2020
06 Apr 2020 New trial record New trial record Updated 06 Apr 2020
02 Apr 2020 Other trial event According to an Ansun Biopharma Media Release, this two-stage trial will initially enroll approximately 20 patients at medical centers across the United States. The Company expects to expand enrollment after an interim review of the data. Updated 06 Apr 2020
02 Apr 2020 Other trial event According to an Ansun Biopharma Media Release, the company announced the initiation of an additional randomized, double-blind, placebo-controlled proof-of-concept trial to determine the safety and efficacy of DAS181 for the treatment of severe COVID-19 pneumonia. Updated 06 Apr 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
  3. Ansun Biopharma. Ansun Biopharma Enrolls First Patient in Proof of Concept Trial of DAS181 for the Treatment of COVID-19. Media-Rel 2020;.

    Media Release
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