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DAS181 for STOP COVID-19

Primary Purpose

COVID-19

Status

Withdrawn

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

DAS181

Placebo

DAS181

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Lower Respiratory Tract Disease, DAS181, SARS-CoV-2, Coronavirus, Hypoxemia, Ansun

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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%
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
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

Exclusion Criteria:

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
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.

Sites / Locations

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
A.O.U Policlinico Di Modena

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

DAS181 b.i.d.+ standard local care for COVID-19

Placebo+ standard local care for COVID-19

DAS181 q.d.+ standard local care for COVID-19

Arm Description

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

nebulized inhalation for 10 consecutive days + standard local care for COVID-19

4.5 mg placebo q.d. nebulized inhalation for 10 consecutive days + standard local care for COVID-19

Outcomes

Primary Outcome Measures

Percent of subjects return to room air (RTRA)

Secondary Outcome Measures

Percent of subjects who have recovered

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

Improved COVID-19 Clinical Classification

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

Return To Room Air (RTRA)

Percent of subjects RTRA

Percent of subjects who achieve clinical stability

SARS-CoV-2 RNA undetectable

Time to

Clinical Deterioration

Time to

Percent of subjects discharged

Percent of subjects discharge

Death (all cause)

Time to

Full Information

NCT ID

NCT04354389

First Posted

April 15, 2020

Last Updated

August 7, 2020

Sponsor

Ansun Biopharma, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04354389

Brief Title

DAS181 for STOP COVID-19

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Withdrawn

Why Stopped

No COVID-19 in EU countries - Sponsor withdraw in regulatory stage

Study Start Date

July 25, 2020 (Anticipated)

Primary Completion Date

September 30, 2020 (Anticipated)

Study Completion Date

November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ansun Biopharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

COVID-19, Lower Respiratory Tract Disease, DAS181, SARS-CoV-2, Coronavirus, Hypoxemia, Ansun

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DAS181 b.i.d.+ standard local care for COVID-19

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo+ standard local care for COVID-19

Arm Type

Placebo Comparator

Arm Description

nebulized inhalation for 10 consecutive days + standard local care for COVID-19

Arm Title

DAS181 q.d.+ standard local care for COVID-19

Arm Type

Experimental

Arm Description

4.5 mg placebo q.d. nebulized inhalation for 10 consecutive days + standard local care for COVID-19

Intervention Type

Drug

Intervention Name(s)

DAS181

Intervention Description

4.5 mg b.i.d

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

q.d. or b.i.d.

Intervention Type

Drug

Intervention Name(s)

DAS181

Intervention Description

4.5 mg q.d.

Primary Outcome Measure Information:

Title

Percent of subjects return to room air (RTRA)

Time Frame

Day 14

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Return To Room Air (RTRA)

Description

Percent of subjects RTRA

Time Frame

Day 10, 21, 28

Title

Percent of subjects who achieve clinical stability

Time Frame

Day 28

Title

SARS-CoV-2 RNA undetectable

Description

Time to

Time Frame

Day 28

Title

Clinical Deterioration

Description

Time to

Time Frame

Day 28

Title

Percent of subjects discharged

Description

Percent of subjects discharge

Time Frame

Day 14, 21, 28

Title

Death (all cause)

Description

Time to

Time Frame

Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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: 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 Exclusion Criteria: 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Ho, MD, PhD

Organizational Affiliation

Ansun Biopharma, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

City

Milano

Country

Italy

Facility Name

A.O.U Policlinico Di Modena

City

Modena

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

DAS181 for STOP COVID-19

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