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DAS181 for STOP COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04354389
Recruitment Status : Withdrawn (No COVID-19 in EU countries - Sponsor withdraw in regulatory stage)
First Posted : April 21, 2020
Last Update Posted : August 11, 2020
Information provided by (Responsible Party):
Ansun Biopharma, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: DAS181 Drug: Placebo Phase 2 Phase 3

Detailed Description:

The first stage is randomized, double-blind study to confirm the optimal dose of the study. Twenty-two (n=22) subjects with COVID-19 and clinically significant impairment of respiratory function will be enrolled to evaluate the two dosing regimens (4.5mg-q.d or 4.5mg-b.i.d) of DAS181. At the end of Stage 1, the Sponsor will evaluate the dose regimen based on the safety and efficacy assessments of the data. An optimal dose will be selected to proceed to Stage 2.

The second stage is a randomized, placebo-controlled and double-blind study to expand enrollment with an additional eighty-two (n=82) subjects to provide adequate power to potentially demonstrate statistically significant therapeutic efficacy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: DAS181 for COVID-19: A Phase II Multicenter, Randomized, Placebo-Controlled, Double-Blind Study
Estimated Study Start Date : July 25, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.

Placebo Comparator: 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.

Experimental: 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

Primary Outcome Measures :
  1. Percent of subjects return to room air (RTRA) [ Time Frame: Day 14 ]

Secondary Outcome Measures :
  1. Percent of subjects who have recovered [ Time Frame: Day 5, 10, 14, 21, 28 ]
    Percent of subjects who reach level 1 of COVID-19 Clinical Classification (discharged or return to normal activity)

  2. Improved COVID-19 Clinical Classification [ Time Frame: Day 28 ]
    time to Improved COVID-19 Clinical Classification 1 to 6 (where higher score means worse outcome)

  3. Return To Room Air (RTRA) [ Time Frame: Day 10, 21, 28 ]
    Percent of subjects RTRA

  4. Percent of subjects who achieve clinical stability [ Time Frame: Day 28 ]
  5. SARS-CoV-2 RNA undetectable [ Time Frame: Day 28 ]
    Time to

  6. Clinical Deterioration [ Time Frame: Day 28 ]
    Time to

  7. Percent of subjects discharged [ Time Frame: Day 14, 21, 28 ]
    Percent of subjects discharge

  8. Death (all cause) [ Time Frame: Day 28 ]
    Time to

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04354389

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Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milano, Italy
A.O.U Policlinico Di Modena
Modena, Italy
Sponsors and Collaborators
Ansun Biopharma, Inc.
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Study Director: Jennifer Ho, MD, PhD Ansun Biopharma, Inc.
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Responsible Party: Ansun Biopharma, Inc. Identifier: NCT04354389    
Other Study ID Numbers: DAS181-2-08
2020-003192-17 ( EudraCT Number )
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ansun Biopharma, Inc.:
Lower Respiratory Tract Disease
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases