Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

Part of paid clinical trials in Mobile, Alabama.

Sponsor
AstraZeneca
Study ID
NCT05624450
Phase
PHASE3
Status
Recruiting
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Conditions

  • Viral Lung Infection and Acute Respiratory Failure

Eligibility Criteria

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

Interventions

  • Tozorakimab — DRUG
    Single IV dose of tozorakimab on Day 1.
  • Placebo — DRUG
    Single IV dose of matching placebo on Day 1.

Study Details

The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.

Key Dates

Start date
Dec 13, 2022
Status verified
Nov 2025
Primary completion
Jun 19, 2026
Completion
Jun 19, 2026

Study Design

Enrollment
2,870 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tozorakimab
    Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1435) will receive a single dose of tozorakimab.
  • Placebo Comparator: Placebo
    Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1435) will receive matching placebo.

Primary Outcome Measure

Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO) [ Time Frame: by Day 28 ]

Central Contacts

Locations (68)

FacilityCityStateZIPSite coordinators
Research SiteMobileAlabama36608-
Research SitePhoenixArizona85008-
Research SitePhoenixArizona85013-
Research SiteTucsonArizona85719-
Research SiteChula VistaCalifornia91911-
Research SiteFresnoCalifornia93701-
Research SiteLa MesaCalifornia91942-
Research SiteLos AngelesCalifornia90027-
Research SiteNewport BeachCalifornia92663-
Research SiteTorranceCalifornia90505-
Research SiteColorado SpringsColorado80909-
Research SiteDenverColorado80206-
Research SiteWashington D.C.District of Columbia20037-
Research SiteBradentonFlorida34209-
Research SiteBradentonFlorida34209-
Research SiteGainesvilleFlorida32611-
Research SiteJacksonvilleFlorida32224-
Research SiteLakelandFlorida33805-
Research SiteMiamiFlorida33144-
Research SiteSouth PasadenaFlorida33707-
Research SiteSt. PetersburgFlorida33709-
Research SiteTampaFlorida33617-
Research SiteAtlantaGeorgia30322-
Research SiteBoiseIdaho83702-
Research SiteChicagoIllinois60612-
Research SiteElmhurstIllinois60126-
Research SiteEvanstonIllinois60201-
Research SiteFort WayneIndiana46804-
Research SiteIowa CityIowa52242-
Research SiteKansas CityKansas66160-
Research SiteLouisvilleKentucky40202-
Research SiteBaton RougeLouisiana70808-
Research SiteNew OrleansLouisiana70121-
Research SiteShreveportLouisiana71103-
Research SiteAnnapolisMaryland21401-
Research SiteSilver SpringMaryland20910-
Research SiteSpringfieldMassachusetts01199-
Research SiteWorcesterMassachusetts01655-
Research SiteDetroitMichigan48202-
Research SiteRoyal OakMichigan48073-
Research SiteSaint PaulMinnesota55101-
Research SiteColumbiaMissouri65212-
Research SiteKansas CityMissouri64108-
Research SiteSt LouisMissouri63110-
Research SiteBrooklynNew York11203-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10039-
Research SitePotsdamNew York13676-
Research SiteChapel HillNorth Carolina27514-
Research SiteGreenvilleNorth Carolina27834-
Research SiteWinston-SalemNorth Carolina27157-
Research SiteColumbusOhio43210-
Research SiteOklahoma CityOklahoma73104-
Research SiteCorvallisOregon97330-
Research SitePortlandOregon97239-
Research SitePhiladelphiaPennsylvania19107-
Research SiteProvidenceRhode Island02903-
Research SiteGreenvilleSouth Carolina29605-
Research SiteSioux FallsSouth Dakota57105-
Research SiteDallasTexas75203-
Research SiteDallasTexas75204-
Research SiteEl PasoTexas79905-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77090-
Research SiteSalt Lake CityUtah84107-
Research SiteCharlottesvilleVirginia22908-
Research SiteGreen BayWisconsin54311-
Research SiteMilwaukeeWisconsin53295-

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