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COVID-19Phase 3NCT05780437

AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

A Phase 3 study testing AZD7442 and Remdesivir in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 124 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study looks at the safety and effectiveness of AZD7442 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a AZD7442 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H4. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
AZD7442 and Remdesivir
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,455 participants
Where
124 sitesin 9 countries
Study dates
10 Feb 2021to 9 Jun 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Refer to the master protocol (NCT04501978)

Who cannot join

  • Refer to the master protocol (NCT04501978)
  • Additional Exclusion Criteria:
  • Pregnant women
  • Nursing mothers
  • Women of child-bearing potential who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through the entire 18 months of the study
  • Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through the entire 18 months of the study.
  • In addition, prior to the initial futility assessment which is performed when approximately 150 participants have been enrolled on AZD7442 and 150 on placebo, patients on high-flow oxygen or non-invasive ventilation (category 5 of the pulmonary ordinal outcome) will be excluded. These patients may be eligible for the trial if the initial futility assessment is passed by this agent.

Trial locations and contacts

124 sites in 9 countries.

124 sites in 9 countries

United States88 sites

  • Hendrick Medical Center (Site 080-014), 1900 Pine Street

    Abilene, Texas, 79601

  • University of Michigan (Site 205-001), 1500 East Medical Center Drive

    Ann Arbor, Michigan, 48109

  • Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE

    Atlanta, Georgia, 30322

  • University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue

    Aurora, Colorado, 80045

  • University of Maryland Medical Center (Site 301-019), 22 South Greene Street

    Baltimore, Maryland, 21201

  • Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104

    Bay Pines, Florida, 33744

  • Massachusetts General Hospital (Site 202-002), 55 Fruit Street

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave.

    Boston, Massachusetts, 02215

  • SUNY Downstate Medical Center (Site 033-001), 450 Clarkson Ave.

    Brooklyn, New York, 11203

  • Maimonides Medical Center (Site 033-002), 4802 10th Avenue

    Brooklyn, New York, 11219

  • Cooper University Hospital (Site 019-001), One Cooper Plaza

    Camden, New Jersey, 08103

  • Ralph H. Johnson VA Medical Center (Site 074-015), 109 Bee Street

    Charleston, South Carolina, 29401

  • MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214

    Charleston, South Carolina, 29425

  • University of Virginia Health Systems (Site 301-021), 1215 Lee Street

    Charlottesville, Virginia, 22903

  • Velocity Chula Vista (Site 080-034), 752 Medical Center Ct., Ste. 304

    Chula Vista, California, 91911

  • University of Cincinnati Medical Center (Site 207-003), 234 Goodman Ave.

    Cincinnati, Ohio, 45219

  • Baycare Health System (Site 301-025), Morton Plant Hospital, 300 Pinellas Street

    Clearwater, Florida, 33756

  • University Hospitals Cleveland Medical Center (Site 108-001), 11100 Euclid Avenue

    Cleveland, Ohio, 44106

  • Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Avenue

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Avenue

    Cleveland, Ohio, 44195

  • CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street

    Corpus Christi, Texas, 78404

  • Parkland Health and Hospital Systems (Site 084-002), 5200 Harry Hines Blvd

    Dallas, Texas, 75235

  • UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor

    Dallas, Texas, 75235

  • Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.

    Dallas, Texas, 75246

  • Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic)

    Denver, Colorado, 80204

  • National Jewish Health / St. Joseph Hospital (Site 204-003), 1400 Jackson Street

    Denver, Colorado, 80206

  • Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd.

    Detroit, Michigan, 48202

  • Duke University Hospital (Site 301-006), 2301 Erwin Road

    Durham, North Carolina, 27710

  • MUSC Health Florence Medical Center (Site 210-006), 805 Pamplico Highway

    Florence, South Carolina, 29505

  • Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard

    Fort Wayne, Indiana, 46804

  • Community Regional Medical Center (Site 203-005), 2823 Fresno Street

    Fresno, California, 93701

  • North Florida/South Georgia Veterans Health System (Site 074-011), 1601 SW. Archer Road

    Gainesville, Florida, 32608-1197

  • Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken Road

    Garfield Heights, Ohio, 44125

  • Memorial Healthcare System (Site 648-002), Memorial Regional Hospital, 3501 Johnson Street

    Hollywood, Florida, 33021

  • Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd.

    Houston, Texas, 77030

  • Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266

    Houston, Texas, 77030

  • University of Mississippi Medical Center (Site 202-005), 2500 North State Street

    Jackson, Mississippi, 39216

  • Velocity San Diego (Site 080-035), 5565 Grossmont Center Drive, Building 2, Suite 1

    La Mesa, California, 91942

  • Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive

    Lebanon, New Hampshire, 03756

  • University of Kentucky Hospital (Site 210-004), 1000 South Limestone St.

    Lexington, Kentucky, 40536

  • VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street

    Loma Linda, California, 92357

  • VA Long Beach Healthcare System (Site 074-026), 5901 East 7th Street (09/151-M2)

    Long Beach, California, 90822

  • CHRISTUS Good Shepherd Medical Center (Site 080-031), 700 E. Marshall Ave.

    Longview, Texas, 75601

  • Keck Hospital of USC (Site 301-020), 1500 San Pablo Street

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd.

    Los Angeles, California, 90048

  • Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza

    Los Angeles, California, 90095

  • Sacramento VA Medical Center (Site 074-023), 10535 Hospital Way

    Mather, California, 95655

  • Miami VAMC (Site 074-003), 1201 NW 16 Street

    Miami, Florida, 33125

  • Minneapolis Heart Institute Foundation (Site 301-026), Abbott Northwestern Hospital, 920 E 28th St. #100

    Minneapolis, Minnesota, 55407

  • Hennepin Healthcare (Site 027-001), 701 Park Avenue

    Minneapolis, Minnesota, 55415

  • Minneapolis VA Health Care System (Site 105-001), 1 Veterans Drive, Bldg 70

    Minneapolis, Minnesota, 55417

  • M Health Fairview University of Minnesota Medical Center (Site 112-001), 500 Harvard St. SE.

    Minneapolis, Minnesota, 55455

  • West Virginia University (Site 301-023), One Medical Center Drive

    Morgantown, West Virginia, 26506

  • Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street

    Murray, Utah, 84107

  • VA TVHS Nashville Campus (Site 074-022), 1310 24th Avenue South

    Nashville, Tennessee, 37212

  • Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive

    Nashville, Tennessee, 37232

  • Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway

    New Orleans, Louisiana, 70121

  • Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive

    Newport Beach, California, 92663

  • UPMC Magee-Womens Hospital (Site 209-003), 300 Halket Street

    Pittsburgh, Pennsylvania, 15213

  • UPMC Presbyterian Hospital (Site 209-001), 200 Lothrop Street

    Pittsburgh, Pennsylvania, 15213

  • UPMC Shadyside Hospital (Site 209-005), 5230 Centre Avenue

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.

    Portland, Oregon, 97239-3098

  • Rhode Island Hospital (Site 080-036), 593 Eddy Street

    Providence, Rhode Island, 02903

  • The Miriam Hospital (Site 080-039), 164 Summit Ave.

    Providence, Rhode Island, 02906

  • VA Providence Healthcare System (Site 074-025), 830 Chalkstone Ave.

    Providence, Rhode Island, 02908

  • Carilion Roanoke Memorial Hospital (Site 080-018), 1906 Belleview Avenue

    Roanoke, Virginia, 24014

  • Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd.

    Salem, Virginia, 24153

  • University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207

    Salt Lake City, Utah, 84108

  • LDS Hospital (Site 211-004), 8th Ave. C Street

    Salt Lake City, Utah, 84143

  • VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village Drive

    San Diego, California, 92161

  • UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.

    San Francisco, California, 94115

  • San Francisco VAMC (Site 074-002), 4150 Clement St.

    San Francisco, California, 94121

  • UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave.

    San Francisco, California, 94143

  • Swedish Hospital First Hill (Site 208-005), 747 Broadway

    Seattle, Washington, 98122

  • Baystate Medical Center (Site 201-001), 759 Chestnut Street

    Springfield, Massachusetts, 01199

  • Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.

    Stanford, California, 94305

  • Hillsborough County Health Department, University of South Florida (Site 032-001)

    Tampa, Florida, 33602

  • Lincoln Medical Center (New York Health and Hospitals/Lincoln) (Site 003-016), 234 E. 149th Street

    The Bronx, New York, 10451

  • Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road

    The Bronx, New York, 10461

  • Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street

    The Bronx, New York, 10467

  • Cotton O'Neil Clinical Research Center (Site 080-030), Stormont Vail Health, 1500 SW 10th Avenue

    Topeka, Kansas, 66604

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson Street, CDCRC Building

    Torrance, California, 90502

  • Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue

    Tucson, Arizona, 85719

  • Southern Arizona VA Healthcare System (Site 074-009), 3601 S. 6th Ave.

    Tucson, Arizona, 85723

  • MedStar Health Research Institute (Site 009-021), MedStar Washington Hospital Center, 110 Irving St., NW.

    Washington D.C., District of Columbia, 20010

  • Washington DC VA Medical Center (Site 009-004), 50 Irving Street NW

    Washington D.C., District of Columbia, 20422

  • West Haven VA Medical Center (Site 025-007), 950 Campbell Avenue

    West Haven, Connecticut, 06516

  • Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd

    Winston-Salem, North Carolina, 27157

Other trials in United States

Denmark10 sites

  • Aalborg Hospital (Site 625-005), Hobrovej 18

    Aalborg, 9000

  • Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99

    Aarhus N, 8200

  • Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23

    Copenhagen, 2400

  • Righospitalet (Site 625-006), Blegdamsvej 9,

    Copenhagen Ø, 2100

  • Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75

    Herlev, 2730

  • Nordsjællands Hospital (Site 625-009), Dyrehavevej 29

    Hillerød, 3400

  • Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30

    Hvidovre, 2650

  • Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24

    Kolding, 6000

  • Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4

    Odense, 5000

  • Zealand University Hospital, Roskilde (Site 625-010), Sygehusvej 10

    Roskilde, 4000

Other trials in Denmark

Spain9 sites

  • Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n

    Badalona, Barcelona, 08916

  • Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebron (Site 626-033), Passeig de la Vall d'Hebron 119-129

    Barcelona, 08035

  • Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170

    Barcelona, 08036

  • Hospital Universitario de Bellvitge (Site 626-034), Carrer de la Feixa Llarga, s/n

    Barcelona, 08907

  • Hospital Universitari Arnau de Vilanova (Site 626-035), Av. Alcalde Rovira Roure 80

    Lleida, Leida, 25198

  • Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46

    Madrid, 28017

  • Hospital Clínico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CN

    Madrid, 28040

  • UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital Maternal

    Madrid, 28046

Other trials in Spain

Uganda6 sites

  • MRC/UVRI and LSHTM Uganda Research Unit (Site 634-601), Entebbe Regional Referral Hospital

    Entebbe

  • Gulu Regional Referral Hospital (Site 634-603), Laroo Division, PO Box 160

    Gulu

  • Makerere University Lung Institute (Site 634-604), New Mulago Hospital Complex, Mulago Hill

    Kampala

  • St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146

    Kampala

  • Lira Regional Referral Hospital (Site 634-605)

    Lira

  • Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556

    Masaka

Other trials in Uganda

Greece5 sites

  • Democritus University of Thrace (Site 635-021), University General Hospital of Alexandroupolis, Dragana

    Alexandroupoli, Evros, 68131

  • Evangelismos COVID-19 Unit, (Site 635-020), 1st Dept. of Pulmonary and Critical Care Medicine, Evangelismos General Hospital, Dept., Ipsilantou 45-47

    Athens, 106 76

  • 1st Respiratory Medicine Dept., Athens University Medical School (Site 635-015), Athens Hospital for Diseases of the Chest "Sotiria Hospital", 152 Mesogeion Ave.

    Athens, 115 27

  • 3rd Dept. of Medicine, Medical School, NKUA (Site 635-022), Sotiria General Hospital, 152 Mesogeion Ave.

    Athens, 115 27

  • Attikon University General Hospital (Site 635-009), 4th Dept. of Internal Medicine, Medical School, National and Kapodistrian University of Athens, 1 Rimini St., Haidari

    Athens, 124 62

Other trials in Greece

United Kingdom3 sites

  • Royal Free Hospital (Site 634-006), Pond Street, Hampstead

    London, NW3 2QG

  • Guy's and St. Thomas' NHS Foundation Trust (Site 634-011)

    London, SE1 7EH

  • Royal Victoria Infirmary (Site 634-007), Queen Victoria Road

    Newcastle upon Tyne, Northumbria, NE1 4LP

Other trials in United Kingdom

Poland1 site

  • Wojewódzki Szpital Zakazny (Site 625-302), Wolska 37

    Warsaw, 01-201

Other trials in Poland

Singapore1 site

  • Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng

    Singapore, 308433

Other trials in Singapore

Switzerland1 site

  • University Hospital Zurich (Site 621-201), Department of Infectious Diseases and Hospital Epidemiology, Raemistrasse 100

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 (Trial H4: AZD7442)

This study looks at the safety and effectiveness of AZD7442 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a AZD7442 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H4.

Read the detailed description

This is a treatment trial of the ACTIV-3/TICO master protocol (NCT04501978) to evaluate the safety and efficacy of AZD7442 in hospitalized patients infected with COVID-19.

This is a randomized, blinded, controlled sub-study of AZD7442 plus current SOC against placebo plus current SOC. The placebo arm may be shared across other sub-studies of the ACTIV-3/TICO master protocol. When more than one drug is being tested at the same time, participants will be randomly allocated to treatments or placebo.

Randomization will be stratified by study site pharmacy and disease severity. There are 2 disease severity strata: participants without organ failure (severity stratum 1) and participants with organ failure (severity stratum 2).

An independent Data and Safety Monitoring Board (DSMB) will regularly review interim analyses and summarize safety and efficacy outcomes. The pace of enrollment with be initially restricted, and there will be an early review of safety data by the DSMB. At the outset of the trial, only participants in disease severity stratum 1 will be enrolled. This will continue until approximately 300 participants are enrolled and followed for 5 days. The exact number will vary according to the speed of enrollment and the timing of DSMB meetings. Prior to expanding enrollment to also include patients in disease severity stratum 2, safety will be evaluated and a pre-specified futility assessment by the DSMB will be carried out using 2 ordinal outcomes assessed at Day 5.

If AZD7442 passes the futility assessment, enrollment of participants will be expanded, seamlessly and without any data unblinding, to include participants in disease severity stratum 2 as well as those in disease severity stratum 1. Future interim analyses will be based on the primary endpoint of sustained recovery and will use pre-specified guidelines to determine early evidence of benefit, harm, or futility for the investigational agent. Participants will be followed for 18 months following randomization.

This trial will be conducted in several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.

Conditions
COVID-19
Being tested
AZD7442, Placebo, Remdesivir
Keywords
COVID-19, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-3, ACTIV3, TICO
Medical subject headings
COVID-19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD7442Biological

    Also called AZD8895 + AZD1061

    AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2.

  • PlaceboBiological

    Commercially available 0.9% sodium chloride solution

  • RemdesivirBiological

    Also called Veklury

    Antiviral agent

Study groups in NCT05780437
Study groupRoleWhat they receive
AZD7442 plus SOCExperimental* AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Receives: Biological: AZD7442; Biological: Remdesivir
Placebo plus SOCPlacebo comparator* Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Receives: Biological: Placebo; Biological: Remdesivir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Sustained Recovery

    The primary endpoint is the proportion of subjects with sustained recovery, which is defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90. Home is defined as the level of residence or facility where the participant was residing prior to hospital admission leading to enrollment in this protocol. Readmission from "home" may occur, and if this occurs within 14 days of the first discharge to "home," then the primary endpoint will not be reached until such time as the participant has been at home for 14 consecutive days.

    Measured: Through Day 90

  2. Number of Participants With an Ordinal Outcome on Day 5

    Ordinal outcome with 7 mutually exclusive categories

    Measured: Status on Day 5

Secondary outcomes (4)

  1. Number of Participants With a Safety Outcome Through Day 5

    Safety outcomes are defined as Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 5. Seriousness was based on the definition of the term at 21CFR312.32

    AEs were graded for severity by the treating investigator, according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (also known at the DAIDS AE Grading Table), U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. [July 2017]. Available from: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf). The following generic grading descriptions from the DAIDS AE Grading Table are provided for context: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening

    Measured: Through Day 5

  2. Number of Participants With a Safety Outcome Through Day 28

    Safety outcomes are defined as Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 28. Seriousness was based on the definition of the term at 21CFR312.32

    AEs were graded for severity by the treating investigator, according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (also known at the DAIDS AE Grading Table), U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. [July 2017]. Available from: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf). The following generic grading descriptions from the DAIDS AE Grading Table are provided for context: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening

    Measured: Through Day 28

  3. Number of Participants With a Safety Outcome Through Day 90

    Safety outcomes are defined as Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 90. Seriousness was based on the definition of the term at 21CFR312.32

    AEs were graded for severity according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (also known at the DAIDS AE Grading Table).

    Measured: Through Day 90

  4. Number of Participants Who Died From All Causes

    All-cause Mortality

    Measured: Through Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2023
  2. Study start10 Feb 2021
  3. Primary completion28 Jan 2022
  4. Study completion9 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,455 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05780437
Sponsor's protocol ID
014/ACTIV-3/H4
Status last verified
Jan 2025
First submitted
20 Mar 2023
Last updated
4 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • ACTIV-3-Therapeutics for Inpatients with COVID-19 (TICO) Study Group. Tixagevimab-cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial. Lancet Respir Med. 2022 Oct;10(10):972-984. doi: 10.1016/S2213-2600(22)00215-6. Epub 2022 Jul 8.

    PubMed 35817072

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AZD7442 and Remdesivir in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 124 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in United States, Denmark, Spain, Uganda, Greece and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Sustained Recovery (time frame: Through Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05780437, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.

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