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Trial record 3 of 5 for:    COVID-19 | DAS181

DAS181 for Patients With Severe Hospitalized Flu and SAD-RVs (COVID-19) (STOP-Flu)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04298060
Recruitment Status : Not yet recruiting
First Posted : March 6, 2020
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Ansun Biopharma, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Influenza Infection SAD-RV Infection and COVID-19 Drug: DAS181 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Stage 2, Ansun will know the dosage.
Primary Purpose: Treatment
Official Title: A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu

Arm Intervention/treatment
Experimental: DAS181 SD group Cohort 1, Stage 1
DAS181 SD group 4.5mg/day for 7 or 10 days
Drug: DAS181
SD (4.5mg/day), HD (9mg/day)

Experimental: DAS181 HD group Cohort 1, Stage 1
DAS181 HD group 9mg/day for 7 or 10 days.
Drug: DAS181
SD (4.5mg/day), HD (9mg/day)

Placebo Comparator: Placebo, Cohort 1, Stage 1
Placebo 0mg/day for 7 or 10 days
Drug: Placebo
Placebo 0mg/day

Experimental: DAS181 group, Cohort 1, Stage 2
DAS181 4.5mg/day or 9mg/day. Dosage will be determined after completion of stage 1.
Drug: DAS181
SD (4.5mg/day), HD (9mg/day)

Placebo Comparator: Placebo, Cohort 1, Stage 2
Placebo 0mg/day for 7 or 10 days
Drug: Placebo
Placebo 0mg/day

Experimental: DAS181 group, Cohort 2, Stage1 and 2
DAS181 4.5mg/day or 9mg/day for 7 or 10 days
Drug: DAS181
SD (4.5mg/day), HD (9mg/day)




Primary Outcome Measures :
  1. Percent of subjects who have returned to room air [ Time Frame: 7 days ]
    Percent of subjects who have returned to room air

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria of Cohort 1 #4 is adapted from the Flu guideline in China (2018) and community acquired pneumonia (CAP) guideline in China (2016)

Cohort 1:

Subjects must meet all of the following inclusion criteria at the time of randomization to be eligible for participation in this study:

  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:

Subjects must meet all of the following inclusion criteria at the time of randomization to be eligible for participation in this study:

  1. Males and Females ≥18 years old
  2. Hypoxemia
  3. Subjects fulfill one of the following conditions:

    1. IFV subjects who are eligible for all inclusion criteria of Cohort 1 except for acute hypoxemia at enrollment.
    2. Subjects confirmed with non-IFV SAD viral infection.
  4. Same in inclusion criteria #5 to #8 in Cohort 1.

Exclusion Criteria

Cohort 1 and 2:

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04298060


Contacts
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Contact: Ivy Fan +86 186 2190 9313 ifan@ansunbiopharma.com
Contact: Sylvie Lu-Hinh 858-452-2631 ext 199 slu-hinh@ansunbiopharma.com

Locations
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China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Sponsors and Collaborators
Ansun Biopharma, Inc.
Investigators
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Study Director: Jennifer Ho, MD, PhD Ansun Biopharma, Inc.
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Responsible Party: Ansun Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT04298060    
Other Study ID Numbers: DAS181-2-07
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ansun Biopharma, Inc.:
Severe hospitalized influenza
Lower Respiratory Tract Disease
Acute Hypoxemia
DAS181
Ansun
infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases