DAS181 for COVID-19: A Phase II Multicenter, Randomized, Placebo-Controlled, Double-Blind Study
Latest Information Update: 12 Aug 2020
At a glance
- Drugs Oplunofusp (Primary)
- Indications COVID 2019 infections; Respiratory tract infections
- Focus Proof of concept; Therapeutic Use
- Sponsors Ansun Biopharma
- 07 Aug 2020 Study design changed from Parallel Assignment to Sequential Assignment. Number of arms changed from 2 to 3. Experimental arm: DAS181 q.d.+ standard local care for COVID-19 added to study protocol. Primary and secondary outcome measures amended. Study Phase changed from Phase II/III to Phase II.
- 07 Aug 2020 Planned End Date changed from 31 Oct 2020 to 30 Nov 2020.
- 07 Aug 2020 Planned primary completion date changed from 30 Jun 2020 to 30 Sep 2020.
Most Recent Events
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.
Comments
According to ClinicalTrials.gov, this study has been withdrawn prior to enrolment by sponsor in regulatory stage. (No COVID-19 in EU countries)
Primary Endpoints
Percent of subjects return to room air (RTRA)
time_frame: Day 14
Other Endpoints
Percent of subjects who have recovered
description: Percent of subjects who reach level 1 of COVID-19 Clinical Classification (discharged or return to normal activity)
time_frame: Day 5, 10, 14, 21, 28
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
Percent of subjects who achieve clinical stability
time_frame: Day 28
SARS-CoV-2 RNA undetectable
description: Time to
time_frame: Day 28
Clinical Deterioration
description: Time to
time_frame: Day 28
Percent of subjects discharged
description: Percent of subjects discharge
time_frame: Day 14, 21, 28
Death (all cause)
description: Time to
time_frame: Day 28 [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
COVID 2019 infections | treatment | - |
Respiratory tract infections | treatment | - |
Subjects
- Subject Type patients
-
Number
Planned: 82
Actual: 0
- 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. 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. At the time of randomization, classified as critical (life-threatening) disease 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 |
EudraCT2020-003192-17 | European Clinical Trials Database |
DAS181-2-08 | - |
Organisations
- Sponsors Ansun Biopharma
- Affiliations Ansun Biopharma
Trial Dates
-
Initiation Dates
Planned : 25 Jul 2020
-
Primary Completion Dates
Planned : 30 Sep 2020
-
End Dates
Planned : 30 Nov 2020
Other Details
- Design double-blind; multicentre; prospective; randomised; sequential
- Phase of Trial Phase II
- Location Europe; Italy; USA
- Focus Proof of concept; Therapeutic Use
Interventions
Drugs | Route | Formulation |
---|---|---|
OplunofuspPrimary Drug | Inhalation | Powder |
DAS181 q.d.+ standard local care for COVID-19
4.5 mg placebo q.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
nebulized inhalation for 10 consecutive days + standard local care for COVID-19 Drug: Placebo (q.d. or b.i.d.)
DAS181 b.i.d.+ 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 q.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
show details
eslaven@ansunbiopharma.com |
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|
|
Sylvie Lu
858-452-2631 Ext: 199
show details
slu-hinh@ansunbiopharma.com |
-
|
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 Aug 2020 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 12 Aug 2020 |
07 Aug 2020 | Protocol amendment | Study design changed from Parallel Assignment to Sequential Assignment. Number of arms changed from 2 to 3. Experimental arm: DAS181 q.d.+ standard local care for COVID-19 added to study protocol. Primary and secondary outcome measures amended. Study Phase changed from Phase II/III to Phase II. Updated 12 Aug 2020 |
07 Aug 2020 | Completion date | Planned End Date changed from 31 Oct 2020 to 30 Nov 2020. Updated 12 Aug 2020 |
07 Aug 2020 | Other trial event | Planned primary completion date changed from 30 Jun 2020 to 30 Sep 2020. Updated 12 Aug 2020 |
07 Aug 2020 | Other trial event | Planned initiation date changed from 25 May 2020 to 25 Jul 2020. Updated 12 Aug 2020 |
07 Aug 2020 | Status change - withdrawn prior to enrolment | Status changed from recruiting to withdrawn prior to enrolment by sponsor in regulatory stage. Updated 12 Aug 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
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ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Ansun Biopharma. Ansun Biopharma Announces Positive Results from Investigator-Initiated Trial of Novel COVID-19 Treatment. Media-Rel 2020;.
Media Release -
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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