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

Part of paid clinical trials in Duarte, California.

Sponsor
Ansun Biopharma, Inc.
Study ID
NCT03808922
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • DAS181 — DRUG
    DAS181 4.5mg nebulized qd x 7 OR 10 days
  • Placebo — DRUG
    Placebo nebulized qd x 7 OR 10 days
  • DAS181 COVID-19 — DRUG
    DAS181 4.5mg nebulized q12h/day x 7 OR 10 days
  • DAS181 OL — DRUG
    DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days \< 40kg

Study Details

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.

Key Dates

Start date
May 23, 2019
Status verified
Jun 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
274 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 and Cohort 2 Treatment
    DAS181 4.5mg qd x 7 OR 10 days
  • Placebo Comparator: Cohort 1 and Cohort 2 Placebo
    Placebo qd x 7 OR 10 days
  • Experimental: Cohort 3
    DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (\< 40kg)
  • Experimental: Cohort 4
    DAS181 4.5mg qd x 7 OR 10 days
  • Experimental: DAS181 COVID-19 Treatment
    DAS181 4.5mg q12h x 7 OR 10 days
  • Placebo Comparator: DAS181 COVID-19 Placebo
    Placebo q12h x 7 OR 10 days

Primary Outcome Measure

Percent of subjects who Return to Room Air (RTRA) (main study) [ Time Frame: by Day 28 ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
City of Hope cancer CenterDuarteCalifornia91010-
University of California Davis Health SystemSacramentoCalifornia95817
Stuart Cohen, MD
Stuart Cohen, MD (PRINCIPAL_INVESTIGATOR)
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611-
University of Iowa Health CareIowa CityIowa52242-
University of Kansas Medical CenterFairwayKansas66205-
The Johns Hopkins HospitalBaltimoreMaryland21205-
Brigham and Women's HospitalBostonMassachusetts02115-
Mayo Clinic RochesterRochesterMinnesota55905
Paschalis Vergidis, MD (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63112-
Weill Cornell Medical CollegeNew YorkNew York10065
Rosypriya Kodiyanplakkal, MD
Rosypriya Kodiyanplakkal, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27710
Cameron Wolfe, MD
Cameron Wolfe, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45267-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Oregon Health & Science UniversityPortlandOregon97239-
University of Pittsburgh Medical Center Health SystemPittsburghPennsylvania15213-
UT Southwestern Medical CenterDallasTexas75390-
Baylor College of MedicineHoustonTexas77030
Puneet Garcha (PRINCIPAL_INVESTIGATOR)
MD AndersonHoustonTexas77030-
VCU Health SystemRichmondVirginia23298
Kristin Miller, MD
[email protected]
804-828-9041
Kristin Miller, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer CenterSeattleWashington98109-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-
Seattle Children's HospitalSeattleWashington98105-
Froedtert Medical College Pulmonary ClinicMilwaukeeWisconsin53266-

Find similar trials in Duarte, CA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
City of Hope cancer Center· Duarte, CAUniversity of California Davis Health System· Sacramento, CAAnn & Robert H. Lurie Children's Hospital of Chicago· Chicago, ILUniversity of Iowa Health Care· Iowa City, IAUniversity of Kansas Medical Center· Fairway, KSThe Johns Hopkins Hospital· Baltimore, MD

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