RecruitingPhase 3

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

United States274 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

SexALL

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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
✕. Female subjects 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 pulmonary 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
✕. Subjects with known hypersensitivity to DAS181 and/or any of its components
✕. Subjects with severe sepsis due to either their baseline SAD-RV infection or a concurrent viral, bacterial, or fungal infection and meet at least one of the following criteria:
✕. Subjects requiring invasive mechanical, Bi-PAP or CPAP ventilation at randomization.

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 completion2025-08-31

Contact for this trial

Lisa Li

858-353-4948 lli@ansunbiopharma.com

View on ClinicalTrials.gov More Lower Respiratory Tract Infection trials