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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 5, day 10, day 14, day 21, day 28
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I have received chemotherapy for cancer in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 5, day 10, day 14, day 21, day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 5, day 10, day 14, day 21, day 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)
Secondary outcome measures
All-cause mortality rate (main study)
Baseline SAD-RV infection-related mortality rate (main study)
Change in pulmonary function (FEV1% predicted) (main study)
+13 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man who has not had a vasectomy and will use birth control.I have a weakened immune system due to a transplant, chemotherapy, a genetic condition, or a recent serious lung infection.I understand and can follow the study's procedures.I am currently taking a trial drug for lung infection.You have certain abnormal liver function test results.I need a ventilator due to COVID-19, am not HIV-positive, and don't take immunomodulating biologics.I am over 18, can care for myself, and have a severe lung infection from COVID-19.You have a mental illness, use recreational drugs or alcohol, or are allergic to DAS181 or any of its parts.You have a weakened immune system, as determined by certain conditions or treatments.I need extra oxygen of 2 liters per minute or more.I have severe sepsis from a SAD-RV infection or another infection.I am aware of and comply with the pregnancy prevention measures required for the trial.I am under 18 with an immune system issue from birth or was born prematurely and am 2 or younger.I have had a stem cell transplant in the past.I have received chemotherapy for cancer in the past.I have had a stem cell transplant in the past.A woman who is not of childbearing potential or is of childbearing potential and has a negative urine/serum pregnancy test agrees to practice an acceptable method of contraception.I need extra oxygen of 2 liters per minute or more.I have received chemotherapy for cancer in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3
- Group 2: Cohort 1 and Cohort 2 Placebo
- Group 3: DAS181 COVID-19 Treatment
- Group 4: Cohort 1 and Cohort 2 Treatment
- Group 5: Cohort 4
- Group 6: DAS181 COVID-19 Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Bronchitis Patient Testimony for trial: Trial Name: NCT03808922 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Across how many hospitals is this research being conducted?
"There are a total of 25 clinical trial sites currently operational. Some notable locations include University of California Davis Health System in Sacramento, Beth Israel Deaconess Medical Center in Boston, and Froedtert Medical College Pulmonary Clinic in Milwaukee."
Answered by AI
What prior research has there been on DAS181 for coronavirus?
"DAS181 COVID-19 was first studied in the year 2019 at The Wesley Hospital. Since then there have been 18295 completed trials. There is presently 1 live trial, with a large number of these studies being performed out of Sacramento, California."
Answered by AI
Has the food and drug administration given DAS181 the okay to be used as a treatment against COVID-19?
"Given that this is a Phase 3 trial with evidence of efficacy and multiple rounds of data supporting safety, the Power team rates DAS181 COVID-19 as having a high level of safety at 3."
Answered by AI
Do we have any previous cases to compare this trial to?
"DAS181 COVID-19 has been researched since 2019, with the earliest clinical trials sponsored by Ansun Biopharma, Inc. In 2019, one such study involving 274 people was completed and led to DAS181 COVID-19's approval in Phase 3 drug development. As of now, there is one active study being conducted on the medication, again sponsored by Ansun Biopharma, Inc."
Answered by AI
Are there still opportunities for people to enroll in this research project?
"From the information available on clinicaltrials.gov, it appears that this trial is still recruiting patients. The listing was originally posted on May 23rd, 2019 and was last edited June 3rd, 2020."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
California
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
2
What site did they apply to?
City of Hope cancer Center
Cook Children's
Why did patients apply to this trial?
I have an autoimmune condition, Hashimoto disease. Dou to my having a splenectomy and had chemotherapy for the cancer I had wanted to make sure that my immunity system is up to par.
PatientReceived 2+ prior treatments
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