CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 274 target
Drug / intervention
DAS181 +3 moredrug
Likely dose
DAS181 4.5mgfrom record
Key inclusion· 12
  • ✓Requires supplemental oxygen ≥2 LPM due to hypoxemia at randomization
  • ✓Immunocompromised status (prior HSCT, solid organ transplant, chemotherapy for malignancies, or congenital/prematurity-related immunodeficiency)
  • ✓Confirmed lower respiratory tract infection with sialic acid dependent respiratory virus within 3 days prior to randomization
  • ✓Acceptable pregnancy status or contraception for females of childbearing potential
Key exclusion· 11
  • ✕On hospice care or low chance of survival during first 10 days of treatment
  • ✕ALT, AST, or ALP ≥3x ULN and Total Bilirubin ≥2x ULN (unless chronically stable due to known liver pathology)
  • ✕Female subjects breastfeeding or planning to breastfeed through 30 days after last study drug dose
  • ✕Taking other investigational drugs for pulmonary infection treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03808922
NCT03808922Phase 3RecruitingOn Track
Long Recruiting
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A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

Ansun Biopharma, Inc.·interventional·Posted Jan 18, 2019·Updated Jun 23, 2026

In Brief

A Phase 3 clinical trial evaluating DAS181, Placebo, and 2 other interventions for Lower Respiratory Tract Infection and 3 related conditions. Currently recruiting, targeting 274 participants across 28 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLower Respiratory Tract Infection, Parainfluenza, Immunocompromised, COVID-19
CountriesAustralia, China, South Korea, Taiwan, United States
Collaborators--

Timeline

Phase 3Recruiting
2019202020212022202320242025202620272028
First PostedJan 18, 2019
Enrollment StartMay 23, 2019
Primary CompletionSep 1, 2028
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 7.5 years agoPrimary completion in 2.2 years

Arms & Interventions

Cohort 1 and Cohort 2 Treatmentexperimental

DAS181 4.5mg qd x 7 OR 10 days

Drug: DAS181
Cohort 1 and Cohort 2 Placeboplacebo_comparator

Placebo qd x 7 OR 10 days

Drug: Placebo
Cohort 3experimental

DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (\< 40kg)

Drug: DAS181 OL
Cohort 4experimental

DAS181 4.5mg qd x 7 OR 10 days

Drug: DAS181 OL
DAS181 COVID-19 Treatmentexperimental

DAS181 4.5mg q12h x 7 OR 10 days

Drug: DAS181 COVID-19
DAS181 COVID-19 Placeboplacebo_comparator

Placebo q12h x 7 OR 10 days

Drug: Placebo

Interventions

DAS181drug

DAS181 4.5mg nebulized qd x 7 OR 10 days

Placebodrug

Placebo nebulized qd x 7 OR 10 days

DAS181 COVID-19drug

DAS181 4.5mg nebulized q12h/day x 7 OR 10 days

DAS181 OLdrug

DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days \< 40kg