Influenza InfectionPhase 2STOP-FluNCT04298060
DAS181 for Patients With Severe Hospitalized Flu and SAD-RVs (COVID-19)
A Phase 2 study testing DAS181 in people with Influenza Infection and SAD-RV Infection and COVID-19, run by Ansun Biopharma, Inc. at 1 site in China.
Trial summary
This is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza Infection, SAD-RV Infection and COVID-19
- What is being tested?
- DAS181
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- Jul 2020to Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Cohort 1 and 2:
- Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
- Subjects requiring mechanical, Bi-PAP or CPAP ventilation at randomization.
- Life expectancy less than 30 days.
- Subjects with conscious disturbance (slow response, drowsy, restlessness, anxiety, confusion, twitching or convulsion)
- Subjects with unstable hemodynamics such as systolic blood pressure < 90 mmHg or septic shock
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- Subjects with BUN≧7.14 mmol/L
- Subjects treated with inhaled anti-viral therapy and washout period ≦ 48 hours.
- If Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) or Alkaline Phosphatase (ALP) are ≥3x ULN and Total Bilirubin (TB) is ≥2x ULN.
- 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.
- Subjects taking any other investigational drug used to treat for another respiratory infection.
- Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
Official title: A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection
This is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study.
Read the detailed description
Cohort 1: It is designed as a two stage, multi-center, randomized, double-blind, two parallel doses, placebo-controlled study that will investigate the efficacy of DAS181 for the treatment of serious IFV in hospitalized patients who suffered from acute hypoxemia requiring supplemental oxygen therapy.
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
- Influenza Infection, SAD-RV Infection and COVID-19
- Being tested
- DAS181, Placebo
- Keywords
- Severe hospitalized influenza, Lower Respiratory Tract Disease, Acute Hypoxemia, DAS181, Ansun, infection
- Medical subject headings
- COVID-19, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAS181Drug
SD (4.5mg/day), HD (9mg/day)
PlaceboDrug
Placebo 0mg/day
| Study group | Role | What they receive |
|---|---|---|
| DAS181 SD group Cohort 1, Stage 1 | Experimental | DAS181 SD group 4.5mg/day for 7 or 10 days Receives: Drug: DAS181 |
| DAS181 HD group Cohort 1, Stage 1 | Experimental | DAS181 HD group 9mg/day for 7 or 10 days. Receives: Drug: DAS181 |
| Placebo, Cohort 1, Stage 1 | Placebo comparator | Placebo 0mg/day for 7 or 10 days Receives: Drug: Placebo |
| DAS181 group, Cohort 1, Stage 2 | Experimental | DAS181 4.5mg/day or 9mg/day. Dosage will be determined after completion of stage 1. Receives: Drug: DAS181 |
| Placebo, Cohort 1, Stage 2 | Placebo comparator | Placebo 0mg/day for 7 or 10 days Receives: Drug: Placebo |
| DAS181 group, Cohort 2, Stage1 and 2 | Experimental | DAS181 4.5mg/day or 9mg/day for 7 or 10 days Receives: Drug: DAS181 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of subjects who have returned to room air
Percent of subjects who have returned to room air
Measured: 7 days
Percent change of subjects return to baseline oxygen requirement
Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study startJul 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ansun Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Ho, MD, PhD, Study director, Ansun Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298060
- Sponsor's protocol ID
- DAS181-2-07
- Acronym
- STOP-Flu
- Status last verified
- Jul 2020
- First submitted
- 28 Feb 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection
- ClinicalTrials.gov ID
- NCT04298060
- Acronym / sponsor ID
- STOP-Flu / DAS181-2-07
- Conditions
- Influenza Infection, SAD-RV Infection and COVID-19
- Keywords
- Severe hospitalized influenza, Lower Respiratory Tract Disease, Acute Hypoxemia, DAS181, Ansun, infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Ansun Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study.
Detailed description
Cohort 1: It is designed as a two stage, multi-center, randomized, double-blind, two parallel doses, placebo-controlled study that will investigate the efficacy of DAS181 for the treatment of serious IFV in hospitalized patients who suffered from acute hypoxemia requiring supplemental oxygen therapy.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| DAS181 SD group Cohort 1, Stage 1 | Experimental | Drug: DAS181DAS181 SD group 4.5mg/day for 7 or 10 days |
| DAS181 HD group Cohort 1, Stage 1 | Experimental | Drug: DAS181DAS181 HD group 9mg/day for 7 or 10 days. |
| Placebo, Cohort 1, Stage 1 | Placebo comparator | Drug: PlaceboPlacebo 0mg/day for 7 or 10 days |
| DAS181 group, Cohort 1, Stage 2 | Experimental | Drug: DAS181DAS181 4.5mg/day or 9mg/day. Dosage will be determined after completion of stage 1. |
| Placebo, Cohort 1, Stage 2 | Placebo comparator | Drug: PlaceboPlacebo 0mg/day for 7 or 10 days |
| DAS181 group, Cohort 2, Stage1 and 2 | Experimental | Drug: DAS181DAS181 4.5mg/day or 9mg/day for 7 or 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
- Subjects requiring mechanical, Bi-PAP or CPAP ventilation at randomization.
- Life expectancy less than 30 days.
- Subjects with conscious disturbance (slow response, drowsy, restlessness, anxiety, confusion, twitching or convulsion)
- Subjects with unstable hemodynamics such as systolic blood pressure < 90 mmHg or septic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAS181SD (4.5mg/day), HD (9mg/day) | Drug | DAS181 HD group Cohort 1, Stage 1, DAS181 SD group Cohort 1, Stage 1, DAS181 group, Cohort 1, Stage 2, DAS181 group, Cohort 2, Stage1 and 2 |
| PlaceboPlacebo 0mg/day | Drug | Placebo, Cohort 1, Stage 1, Placebo, Cohort 1, Stage 2 |
Primary outcome
Percent of subjects who have returned to room air
Time frame: 7 days
Percent of subjects who have returned to room air
Percent change of subjects return to baseline oxygen requirement
Time frame: 7 days
Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Ho, MD, PhD study director
Ansun Biopharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DAS181 in people with Influenza Infection and SAD-RV Infection and COVID-19, run by Ansun Biopharma, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivy Fan (+86 186 2190 9313, ifan@ansunbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of subjects who have returned to room air (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.