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
May 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 (49)

FacilityCityStateZIPSite coordinators
City of Hope cancer CenterDuarteCalifornia91010-
UCLALos AngelesCalifornia90024-
University of California Davis Health SystemSacramentoCalifornia95817
Stuart Cohen, MD
Stuart Cohen, MD (PRINCIPAL_INVESTIGATOR)
University of California San Diego Medical CenterSan DiegoCalifornia92093-
Children's Hospital ColoradoAuroraColorado80045-
Sylvester Comprehensive Cancer Center, University of Miami Health SystemMiamiFlorida33136-
Houston Methodist HospitalTampaFlorida33612-
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611-
University of ChicagoChicagoIllinois60637-
Loyola University Medical CenterMaywoodIllinois60153-
University of Iowa Health CareIowa CityIowa52242-
University of Kansas Medical CenterFairwayKansas66205-
Louisiana State UniversityShreveportLouisiana71103-
The Johns Hopkins HospitalBaltimoreMaryland21205-
University of MarylandBaltimoreMaryland21201-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02115-
Universtiy of MichiganAnn ArborMichigan48109-
Mayo Clinic RochesterRochesterMinnesota55905
Paschalis Vergidis, MD (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63112-
University of Nebraska Medical CenterOmahaNebraska68198-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
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)
Novant HealthWinston-SalemNorth Carolina27103-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45267-
The Lindner Center- The Christ HospitalCincinnatiOhio45219-
University of CincinnatiCincinnatiOhio45267-
The Cleveland Clinic FoundationClevelandOhio44106-
St. Elizabeth Youngstown HospitalYoungstownOhio44501-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Oregon Health & Science UniversityPortlandOregon97239-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical Center Health SystemPittsburghPennsylvania15213-
Kent HospitalWarwickRhode Island02886-
Vanderbilt University Medical CenterNashvilleTennessee37232-
UT Southwestern Medical CenterDallasTexas75390-
Cook Children'sForth WorthTexas76104-
Texas HealthForth WorthTexas76104-
Baylor College of MedicineHoustonTexas77030
Puneet Garcha (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030-
MD AndersonHoustonTexas77030-
Therapeutic ConceptsHoustonTexas77004-
VCU Health SystemRichmondVirginia23298
Kristin Miller, MD
Kristin Miller, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer CenterSeattleWashington98109-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-
Seattle Children's HospitalSeattleWashington98105-
Froedtert Medical College Pulmonary ClinicMilwaukeeWisconsin53266
Jonathon Truwit, MD
Jonathon Truwit, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226-

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, CAUCLA· Los Angeles, CAUniversity of California Davis Health System· Sacramento, CAUniversity of California San Diego Medical Center· San Diego, CAChildren's Hospital Colorado· Aurora, COSylvester Comprehensive Cancer Center, University of Miami Health System· Miami, FL

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