DAS181 for STOP COVID-19
COVID-19
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
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.
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
Experimental
Placebo Comparator
Experimental
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
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