Clinical trial NCT04354389: DAS181 for STOP COVID-19
Official title: DAS181 for COVID-19: A Phase II Multicenter, Randomized, Placebo-Controlled, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: COVID-19
Keywords: COVID-19
Lower Respiratory Tract Disease
DAS181
SARS-CoV-2
Coronavirus
Hypoxemia
Ansun
Lead sponsor: Ansun Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent of subjects return to room air (RTRA)
timeFrame: Day 14
Secondary outcomes:
measure: Percent of subjects who have recovered
timeFrame: Day 5, 10, 14, 21, 28
measure: Improved COVID-19 Clinical Classification
timeFrame: Day 28
measure: Return To Room Air (RTRA)
timeFrame: Day 10, 21, 28
measure: Percent of subjects who achieve clinical stability
timeFrame: Day 28
measure: SARS-CoV-2 RNA undetectable
timeFrame: Day 28
measure: Clinical Deterioration
timeFrame: Day 28
measure: Percent of subjects discharged
timeFrame: Day 14, 21, 28
measure: Death (all cause)
timeFrame: Day 28
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
city: Modena
country: Italy
facility: A.O.U Policlinico Di Modena
Study officials:
affiliation: Ansun Biopharma, Inc.
name: Jennifer Ho, MD, PhD
role: STUDY_DIRECTOR
References: