Status:
WITHDRAWN
DAS181 for STOP COVID-19
Lead Sponsor:
Ansun Biopharma, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04354389
Start Date
July 25 2020
End Date
November 30 2020
Last Update
August 11 2020
Active Locations (2)
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1
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, Italy
2
A.O.U Policlinico Di Modena
Modena, Italy