DAS181 for Patients With Severe Hospitalized Flu and SAD-RVs (COVID-19)
NCT ID: NCT04298060
Last Updated: 2020-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
280 participants
INTERVENTIONAL
2020-07-31
2022-09-30
Brief Summary
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Detailed Description
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Cohort 2: It is designed as an open-label study that will investigate the efficacy of DAS181 for the treatment of patients with sever IFV but not eligible for Cohort 1 and non-IFV SAD viral infection, e.g. parainfluenza virus, human metapneumovirus, enterovirus and all strains of β-coronaviruses (including but not limited to SARS-CoV-2), with hypoxemia requiring supplemental oxygen therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DAS181 SD group Cohort 1, Stage 1
DAS181 SD group 4.5mg/day for 7 or 10 days
DAS181
SD (4.5mg/day), HD (9mg/day)
DAS181 HD group Cohort 1, Stage 1
DAS181 HD group 9mg/day for 7 or 10 days.
DAS181
SD (4.5mg/day), HD (9mg/day)
Placebo, Cohort 1, Stage 1
Placebo 0mg/day for 7 or 10 days
Placebo
Placebo 0mg/day
DAS181 group, Cohort 1, Stage 2
DAS181 4.5mg/day or 9mg/day. Dosage will be determined after completion of stage 1.
DAS181
SD (4.5mg/day), HD (9mg/day)
Placebo, Cohort 1, Stage 2
Placebo 0mg/day for 7 or 10 days
Placebo
Placebo 0mg/day
DAS181 group, Cohort 2, Stage1 and 2
DAS181 4.5mg/day or 9mg/day for 7 or 10 days
DAS181
SD (4.5mg/day), HD (9mg/day)
Interventions
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DAS181
SD (4.5mg/day), HD (9mg/day)
Placebo
Placebo 0mg/day
Eligibility Criteria
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Inclusion Criteria
1. Males and Females ≥18 years old
2. Diagnosed as influenza (IFV) infection within 3 days before randomization
3. Requires, at the time of randomization, supplemental oxygen ≥2 LPM due to hypoxemia
4. Subjects are severely ill
5. In the opinion of investigator, subjects will be hospitalized at least 1 week.
6. If female, subject must not be pregnant or nursing
Cohort 2:
1. Males and Females ≥18 years old
2. Hypoxemia
3. Subjects fulfill one of the following conditions:
2. Subjects confirmed with non-IFV SAD viral infection.
Exclusion Criteria
1. Subjects requiring mechanical, Bi-PAP or CPAP ventilation at randomization.
2. Life expectancy less than 30 days.
3. Subjects with conscious disturbance (slow response, drowsy, restlessness, anxiety, confusion, twitching or convulsion)
4. Subjects with unstable hemodynamics such as systolic blood pressure \< 90 mmHg or septic shock
5. Subjects with BUN≧7.14 mmol/L
6. Subjects treated with inhaled anti-viral therapy and washout period ≦ 48 hours.
7. If Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) or Alkaline Phosphatase (ALP) are ≥3x ULN and Total Bilirubin (TB) is ≥2x ULN.
8. Female subjects with positive pregnancy test result, breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug.
9. Subjects taking any other investigational drug used to treat for another respiratory infection.
10. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance.
18 Years
ALL
No
Sponsors
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Ansun Biopharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jennifer Ho, MD, PhD
Role: STUDY_DIRECTOR
Ansun Biopharma, Inc.
Locations
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Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Other Identifiers
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DAS181-2-07
Identifier Type: -
Identifier Source: org_study_id
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