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Virus Therapy

DAS181 for Respiratory Infections

Phase 3
Recruiting
Research Sponsored by Ansun Biopharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Immunocompromised, as defined by specific criteria including history of stem cell or solid organ transplant, current or past chemotherapy, congenital immunodeficiency, or recent lower respiratory tract infection with a sialic acid dependent respiratory virus
For COVID-19 sub study: Be ≥18 years of age, provide adequate medical history, have the ability to carry out self-care activities of daily living, have confirmed lower respiratory tract infection involving at least 2 lobes of the lung, and satisfy specific inclusion criteria of the main study
Must not have
Subjects taking any other investigational drug used to treat pulmonary infection
Subjects with severe sepsis due to their baseline SAD-RV infection or a concurrent viral, bacterial, or fungal infection and meeting specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up by day 28
Awards & highlights
Pivotal Trial

Summary

This trial will enroll immunocompromised patients with Lower Tract parainfluenza infection to study the safety and efficacy of an investigational vaccine. A sub-study will also enroll patients with severe COVID-19.

Who is the study for?
This trial is for immunocompromised patients, including those who've had stem cell transplants or chemotherapy. It's open to adults and children with certain immune deficiencies and severe COVID-19 needing oxygen but not intensive ventilation. Participants must agree to contraception if applicable.
What is being tested?
The study tests DAS181, a drug for lower respiratory infections in the immunocompromised, against a placebo. A sub-study focuses on severe COVID-19 cases. The goal is to see if DAS181 can help these patients by comparing outcomes between the drug and placebo groups.
What are the potential side effects?
Potential side effects of DAS181 may include reactions at the infusion site, possible allergic responses, changes in liver function tests, and other non-specified drug-related effects as it targets respiratory infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a weakened immune system due to a transplant, chemotherapy, a genetic condition, or a recent serious lung infection.
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I am over 18, can care for myself, and have a severe lung infection from COVID-19.
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I need extra oxygen of 2 liters per minute or more.
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I have had a stem cell transplant in the past.
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I have received chemotherapy for cancer in the past.
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I have had a stem cell transplant in the past.
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I need extra oxygen of 2 liters per minute or more.
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I have received chemotherapy for cancer in the past.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking a trial drug for lung infection.
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I have severe sepsis from a SAD-RV infection or another infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~by day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and by day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of subjects who Return to Room Air (RTRA) (main study)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: DAS181 COVID-19 TreatmentExperimental Treatment1 Intervention
DAS181 4.5mg q12h x 7 OR 10 days
Group II: Cohort 4Experimental Treatment1 Intervention
DAS181 4.5mg qd x 7 OR 10 days
Group III: Cohort 3Experimental Treatment1 Intervention
DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (\< 40kg)
Group IV: Cohort 1 and Cohort 2 TreatmentExperimental Treatment1 Intervention
DAS181 4.5mg qd x 7 OR 10 days
Group V: Cohort 1 and Cohort 2 PlaceboPlacebo Group1 Intervention
Placebo qd x 7 OR 10 days
Group VI: DAS181 COVID-19 PlaceboPlacebo Group1 Intervention
Placebo q12h x 7 OR 10 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DAS181
2011
Completed Phase 1
~120

Find a Location

Who is running the clinical trial?

Ansun Biopharma, Inc.Lead Sponsor
10 Previous Clinical Trials
1,197 Total Patients Enrolled
Jennifer Ho, MDStudy DirectorAnsun Biopharma, Inc.
George WangStudy DirectorAnsun Biopharma, Inc.

Media Library

DAS181 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03808922 — Phase 3
Bronchitis Research Study Groups: Cohort 1 and Cohort 2 Placebo, Cohort 3, DAS181 COVID-19 Treatment, Cohort 1 and Cohort 2 Treatment, Cohort 4, DAS181 COVID-19 Placebo
Bronchitis Clinical Trial 2023: DAS181 Highlights & Side Effects. Trial Name: NCT03808922 — Phase 3
DAS181 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03808922 — Phase 3
Bronchitis Patient Testimony for trial: Trial Name: NCT03808922 — Phase 3
~4 spots leftby Dec 2024
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