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

NCT03808922 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • Lower Respiratory Tract Infection
  • Parainfluenza
  • Immunocompromised
  • COVID-19

Interventions

DRUG

DAS181

DAS181 4.5mg nebulized qd x 7 OR 10 days

DRUG

Placebo

Placebo nebulized qd x 7 OR 10 days

DRUG

DAS181 COVID-19

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

DRUG

DAS181 OL

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

Sponsors & Collaborators

  • Ansun Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Ronald B Moss, MD · Ansun Biopharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-23
Primary Completion
2028-09-01
Completion
2028-09-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Denmark
  • France
  • Hong Kong
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03808922 on ClinicalTrials.gov