RecruitingPhase 3

Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study

United States, Australia, China274 participantsStarted 2019-05-23

Plain-language summary

This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia.
. Immunocompromised, as defined by one or more of the following:
. Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid dependent respiratory virus
. If female, subject must meet one of the following conditions:
. Non-vasectomized males are required to practice effective birth control methods
. Capable of understanding and complying with procedures as outlined in the protocol
. Provides signed informed consent prior to the initiation of any screening or study-specific procedures
. Be ≥18 years of age

Exclusion criteria

. Subjects may not be on hospice care or, in the opinion of the investigator, have a low chance of survival during the first 10 days of treatment
. Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2x ULN Note: Subjects with ALT/AST/ALP ≥ 3x ULN AND TB ≥2x ULN that have been chronically stable (for \>1 year on more than one assessments) due to known liver pathology including malignancy (primary or metastasis), chronic medications, transplantation, or chronic infection will not be excluded

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent of subjects who Return to Room Air (RTRA) (main study)

Timeframe: by Day 28

Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)

Timeframe: Day 14

Trial details

NCT IDNCT03808922

SponsorAnsun Biopharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-09-01

Contact for this trial

Courtney Alcaraz

619-988-2417 cburke@ansunbiopharma.com

View on ClinicalTrials.gov More Lower Respiratory Tract Infection trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia.
. Immunocompromised, as defined by one or more of the following:
. Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid dependent respiratory virus
. If female, subject must meet one of the following conditions:
. Non-vasectomized males are required to practice effective birth control methods
. Capable of understanding and complying with procedures as outlined in the protocol
. Provides signed informed consent prior to the initiation of any screening or study-specific procedures
. Be ≥18 years of age

Exclusion criteria

. Subjects may not be on hospice care or, in the opinion of the investigator, have a low chance of survival during the first 10 days of treatment
. Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2x ULN Note: Subjects with ALT/AST/ALP ≥ 3x ULN AND TB ≥2x ULN that have been chronically stable (for \>1 year on more than one assessments) due to known liver pathology including malignancy (primary or metastasis), chronic medications, transplantation, or chronic infection will not be excluded