DAS181 for STOP COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04354389
• Other study ID #: DAS181-2-08
• Secondary ID: 2020-003192-17
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: July 25, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: August 2020
• Source: Ansun Biopharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• DAS181
4.5 mg b.i.d
• Placebo
q.d. or b.i.d.
• DAS181
4.5 mg q.d.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico	Milano
Italy	A.O.U Policlinico Di Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Ansun Biopharma, Inc.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of subjects return to room air (RTRA)		Day 14
Secondary	Percent of subjects who have recovered	Percent of subjects who reach level 1 of COVID-19 Clinical Classification (discharged or return to normal activity)	Day 5, 10, 14, 21, 28
Secondary	Improved COVID-19 Clinical Classification	time to Improved COVID-19 Clinical Classification 1 to 6 (where higher score means worse outcome)	Day 28
Secondary	Return To Room Air (RTRA)	Percent of subjects RTRA	Day 10, 21, 28
Secondary	Percent of subjects who achieve clinical stability		Day 28
Secondary	SARS-CoV-2 RNA undetectable	Time to	Day 28
Secondary	Clinical Deterioration	Time to	Day 28
Secondary	Percent of subjects discharged	Percent of subjects discharge	Day 14, 21, 28
Secondary	Death (all cause)	Time to	Day 28