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COVID-19Phase 2/3NCT04354389

DAS181 for STOP COVID-19

A Phase 2/3 study testing DAS181 in people with COVID-19, run by Ansun Biopharma, Inc. at 2 sites in Italy.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
DAS181
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
2 sitesItaly
Study dates
25 Jul 2020to 30 Nov 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • At the time of randomization, classified as critical (life-threatening) disease
  • Subjects currently receiving any other investigational drug, as part of a clinical trial or under emergency approval for SARS-CoV-2
  • Subjects who are known asthmatic patients or HIV-positive
  • Subjects who are currently receiving inhaled biologics or anti-viral agents
  • 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
  • Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2xULN
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  • Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug.
  • Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance.
  • Subjects with known hypersensitivity to DAS181 and/or any of its components.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

    Milan

  • A.O.U Policlinico Di Modena

    Modena

Other trials in Italy

About this study

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

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.

Read the 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.

Conditions
COVID-19
Being tested
DAS181, Placebo
Keywords
COVID-19, Lower Respiratory Tract Disease, DAS181, SARS-CoV-2, Coronavirus, Hypoxemia, Ansun
Medical subject headings
COVID-19, Coronavirus Infections, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DAS181Drug

    4.5 mg b.i.d

  • PlaceboDrug

    q.d. or b.i.d.

  • DAS181Drug

    4.5 mg q.d.

Study groups in NCT04354389
Study groupRoleWhat they receive
DAS181 b.i.d.+ standard local care for COVID-19Experimental4.5 mg DAS181 b.i.d nebulized inhalation for 10 consecutive days + standard local care for COVID-19
Receives: Drug: DAS181
Placebo+ standard local care for COVID-19Placebo comparatornebulized inhalation for 10 consecutive days + standard local care for COVID-19
Receives: Drug: Placebo
DAS181 q.d.+ standard local care for COVID-19Experimental4.5 mg placebo q.d. nebulized inhalation for 10 consecutive days + standard local care for COVID-19
Receives: Drug: DAS181

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of subjects return to room air (RTRA)

    Measured: Day 14

Secondary outcomes (8)

  1. Percent of subjects who have recovered

    Percent of subjects who reach level 1 of COVID-19 Clinical Classification (discharged or return to normal activity)

    Measured: Day 5, 10, 14, 21, 28

  2. Improved COVID-19 Clinical Classification

    time to Improved COVID-19 Clinical Classification 1 to 6 (where higher score means worse outcome)

    Measured: Day 28

  3. Return To Room Air (RTRA)

    Percent of subjects RTRA

    Measured: Day 10, 21, 28

  4. Percent of subjects who achieve clinical stability

    Measured: Day 28

  5. SARS-CoV-2 RNA undetectable

    Time to

    Measured: Day 28

  6. Clinical Deterioration

    Time to

    Measured: Day 28

  7. Percent of subjects discharged

    Percent of subjects discharge

    Measured: Day 14, 21, 28

  8. Death (all cause)

    Time to

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2020
  2. Study start25 Jul 2020 (estimated)
  3. Primary completion30 Sep 2020 (estimated)
  4. Study completion30 Nov 2020 (estimated)

Why it stopped: No COVID-19 in EU countries - Sponsor withdraw in regulatory stage

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04354389
Sponsor's protocol ID
DAS181-2-08
Other IDs
2020-003192-17
Status last verified
Aug 2020
First submitted
15 Apr 2020
Last updated
11 Aug 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing DAS181 in people with COVID-19, run by Ansun Biopharma, Inc. at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of subjects return to room air (RTRA) (time frame: Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04354389.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.

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