COVID-19
Conditions
Keywords
COVID-19, Lower Respiratory Tract Disease, DAS181, SARS-CoV-2, Coronavirus, Hypoxemia, Ansun
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.
Interventions
DRUGDAS181
4.5 mg b.i.d
DRUGPlacebo
q.d. or b.i.d.
Sponsors
Ansun Biopharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of subjects return to room air (RTRA) | Day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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) |
| 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 |
| SARS-CoV-2 RNA undetectable | Day 28 | Time to |
Countries
Italy
Outcome results
None listed