DAS181 for STOP COVID-19

Sponsor

Ansun Biopharma, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04354389

Collaborator

(none)

Enrollment

Locations

Arms

4.2

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: DAS181 Drug: Placebo Drug: DAS181	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.

Study Design

Study Type:

Interventional

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

Anticipated Study Start Date :

Jul 25, 2020

Anticipated Primary Completion Date :

Sep 30, 2020

Anticipated Study Completion Date :

Nov 30, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Percent of subjects return to room air (RTRA) [Day 14]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:
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.