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COVID-19Phase 3PROVENTNCT04625725

Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.

A Phase 3 study testing AZD7442 in people with COVID-19, run by AstraZeneca at 89 sites in 5 countries.

Completed

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

Official record
Search all trials

Trial summary

This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
COVID-19
What is being tested?
AZD7442
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5,197 participants
Where
89 sitesin 5 countries
Study dates
21 Nov 2020to 8 Dec 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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years of age at the time of signing the informed consent
  • Can benefit from passive immunization with antibodies
  • Medically stable
  • Negative result from point of care SARS-CoV-2 serology testing at screening
  • Contraceptive used by women of child bearing potential, condom used by men
  • Able to understand and comply with study requirements/procedures based on the assessment of the investigator
Show all 12Show fewer
  • Sub-study Inclusion criteria which are additional to those in parent study are as follows:
  • The participant has been randomized, dosed, and is ongoing in the PROVENT parent study and is 12±2 months post first dose of blinded IMP.
  • If one or more of the following apply:
  • Immunocompromised and/or may be at increased risk for an inadequate immune response to a COVID-19 vaccine.
  • In the opinion of the Investigator, are at increased risk and would benefit from a repeat dose of AZD7442.
  • Documented negative SARS-CoV-2 RT-PCR test collected ≤ 3 days prior to sub-study Day 1 or a negative rapid SARS-CoV-2 antigen test at screening.

Who cannot join

  • Significant infection or other acute illness, including fever >100°F (>37.8°C) on the day prior to or day of randomization.
  • History of laboratory-confirmed SARS-CoV-2 infection or any positive SARS-CoV-2 result based on available data at screening.
  • History of infection with severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS).
  • Known history of allergy or reaction to any component of the study drug formulation.
  • Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of a mAb.
  • Any prior receipt of investigational or licensed vaccine or other mAb/biologic indicated for the prevention of SARS-CoV-2 or COVID-19 or expected receipt during the period of study follow-up.
Show all 17Show fewer
  • Bleeding disorder or prior history of significant bleeding or bruising following IM injections or venepuncture.
  • Any other significant disease, disorder, or finding. that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data.
  • Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study
  • Currently pregnant or breastfeeding.
  • Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to randomization.
  • Employees of the Sponsor involved in planning, executing, supervising, or reviewing the AZD7442 program,, clinical study site staff, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
  • In nations, states, or other jurisdictions that for legal or ethical reasons bar the enrollment of participants who lack capacity to provide their own informed consent, such subjects are excluded.
  • Sub-study Exclusion criteria are as follows:
  • Patient have received a COVID-19 vaccination ≤ 14 days before sub-study Day1 or plan to receive a COVID-19 vaccination ≤ 14 days after sub-study Day1. (Such participants can subsequently be included in the study once they have reached >14 days after their last dose of vaccine).
  • Patient have two or more untreated cardiac risk factors or suspected unstable cardiac disease.
  • Judgment by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.

Trial locations and contacts

89 sites in 5 countries.

89 sites in 5 countries

United States60 sites

  • Research Site

    Albuquerque, New Mexico, 87109

  • Research Site

    Alexandria, Virginia, 22304

  • Research Site

    Atlanta, Georgia, 30328

  • Research Site

    Austin, Texas, 78751

  • Research Site

    Birmingham, Alabama, 35215

  • Research Site

    Cerritos, California, 90703

  • Research Site

    Chesapeake, Virginia, 23320

  • Research Site

    Chicago, Illinois, 60607

  • Research Site

    Clearwater, Florida, 33756

  • Research Site

    Columbus, Georgia, 31904

  • Research Site

    Columbus, Ohio, 43213

  • Research Site

    Conyers, Georgia, 30094

  • Research Site

    Coral Springs, Florida, 33071

  • Research Site

    El Paso, Texas, 79925

  • Research Site

    El Paso, Texas, 79935

  • Research Site

    Evansville, Indiana, 47714

  • Research Site

    Fresno, California, 93720

  • Research Site

    Garden Grove, California, 92844

  • Research Site

    Greensboro, North Carolina, 27410

  • Research Site

    Hartford, Connecticut, 06112

  • Research Site

    Hazel Crest, Illinois, 60429

  • Research Site

    Hollywood, Florida, 33024

  • Research Site

    Honolulu, Hawaii, 96859

  • Research Site

    Houston, Texas, 77054

  • Research Site

    Huntington Beach, California, 92647

  • Research Site

    Jamaica, New York, 11432

  • Research Site

    Lancaster, California, 93534

  • Research Site

    Las Vegas, Nevada, 89128

  • Research Site

    Lauderdale Lakes, Florida, 33313

  • Research Site

    Layton, Utah, 84041

  • Research Site

    Little Rock, Arkansas, 72205

  • Research Site

    Marietta, Georgia, 30060

  • Research Site

    Miami, Florida, 33125

  • Research Site

    Middlebury, Connecticut, 06762

  • Research Site

    Minneapolis, Minnesota, 55404

  • Research Site

    Minneapolis, Minnesota, 55435

  • Research Site

    Modesto, California, 95350

  • Research Site

    Noblesville, Indiana, 46060

  • Research Site

    Oklahoma City, Oklahoma, 73104

  • Research Site

    Omaha, Nebraska, 68134

  • Research Site

    Ormond Beach, Florida, 32174

  • Research Site

    Pompano Beach, Florida, 33064

  • Research Site

    Quincy, Illinois, 62301

  • Research Site

    Rapid City, South Dakota, 57701

  • Research Site

    Ridgewood, New York, 11385

  • Research Site

    San Antonio, Texas, 78215

  • Research Site

    San Antonio, Texas, 78251

  • Research Site

    Shenandoah, Texas, 77384

  • Research Site

    St Louis, Missouri, 63141

  • Research Site

    Sugar Land, Texas, 77479

  • Research Site

    Summerville, South Carolina, 29485

  • Research Site

    Tacoma, Washington, 98402

  • Research Site

    Tempe, Arizona, 85284

  • Research Site

    The Bronx, New York, 10461

  • Research Site

    Victorville, California, 92394

  • Research Site

    Wesley Chapel, Florida, 33545

  • Research Site

    West Palm Beach, Florida, 33409

  • Research Site

    Westminster, California, 92683

  • Research Site

    Wichita, Kansas, 67205

  • Research Site

    Wichita, Kansas, 67214

Other trials in United States

France10 sites

  • Research Site

    Clermont-Ferrand, 63003

  • Research Site

    Dijon, 21079

  • Research Site

    La Roche S/ Yon Cedex 9, 85925

  • Research Site

    Lille, 59037

  • Research Site

    Limoges, 87000

  • Research Site

    Nantes, 44093

  • Research Site

    Paris, 75475

  • Research Site

    Paris, 75679

  • Research Site

    Saint-Etienne, 42055

  • Research Site

    Tours, 37044

Other trials in France

United Kingdom9 sites

  • Research Site

    Bournemouth, BH7 7DW

  • Research Site

    Enfield, EN3 4GS

  • Research Site

    Hayle, TR27 5DT

  • Research Site

    London, WC1N 3BG

  • Research Site

    Preston, PR1 6YA

  • Research Site

    Rochdale, OL11 4AU

  • Research Site

    Salford, M6 8HD

  • Research Site

    Torpoint, PL11 2TB

  • Research Site

    Wakefield, WF1 5RH

Other trials in United Kingdom

Belgium5 sites

  • Research Site

    Alken, 3570

  • Research Site

    Brussels, 1000

  • Research Site

    Gozée, 6534

  • Research Site

    Namur, 5101

  • Research Site

    Wetteren, 9230

Other trials in Belgium

Spain5 sites

  • Research Site

    Barcelona, 08036

  • Research Site

    Madrid, 28034

  • Research Site

    Madrid, 28040

  • Research Site

    Marbella (Málaga), 29603

  • Research Site

    Pozuelo de Alarcón, 28223

Other trials in Spain

About this study

Official title: A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19.

This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.

Read the detailed description

SARS-CoV-2 is the causative agent of the ongoing COVID-19 pandemic that, as of 29 September 2020, has resulted in a high death toll to date. Unlike the majority of coronaviruses that cause mild disease in humans and animals, SARS-CoV-2 can replicate in the lower respiratory tract to cause acute respiratory distress syndrome and fatal pneumonia. Effective interventions to prevent or treat COVID-19 remain limited in number and clinical experience is limited. Clinical management is limited to supportive care, consequently overwhelming resources of healthcare systems around the world. As a response to the ongoing pandemic, AstraZeneca is developing mAbs to the SARS-CoV-2 S protein. The SARS-CoV-2 spike protein contains the virus's RBD, which enables the virus to bind to receptors on human cells. By targeting this region of the virus's spike protein, antibodies can block the virus's attachment to human cells, and, therefore, is expected to block infection. Amino acid substitutions have been introduced into the antibodies to both extend their half-lives, which should prolong their potential prophylactic benefit, and decrease Fc effector function in order to decrease the potential risk of antibody-dependent enhancement of disease. AZD7442, a combination of 2 of these mAbs (AZD8895 and AZD1061), is being evaluated for administration to prevent and/or treat COVID-19. There is currently one completed and 2 ongoing Phase I studies with AZD7442.

-The Provent repeat dose open-label sub-study is initiated to assess the safety, PK and immunogenicity of repeat doses of AZD7442 in participants currently enrolled in the Provent study who may benefit from repeat dose of AZD7442.

Conditions
COVID-19
Being tested
AZD7442, Placebo
Keywords
Pre-exposure Prophylaxis of COVID-19
Medical subject headings
COVID-19

What participants receive

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

  • AZD7442Drug

    Also called Combination of 2mAbs(AZD8895 and AZD1061)

    • Single dose (× 2IM injections) of 300 mg of AZD7442 on parent study Day 1.
    • Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 1.
    • Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 183.
    • Single dose (x 2IM injections) of 600mg of AZD7442 on sub-study Day 183 and Day 366

  • PlaceboDrug

    Single dose (× 2IM injections) of saline placebo on parent study Day 1.

Study groups in NCT04625725
Study groupRoleWhat they receive
AZD7442ExperimentalApproximately 5150 participants will be randomized in a 2:1 ratio • Arm 1 (n=approximately 3433) will receive a single dose (× 2IM injections) of 300 mg of AZD7442
Receives: Drug: AZD7442
PlaceboPlacebo comparatorApproximately 5150 participants will be randomized in a 2:1 ratio • Arm 2 (n=approximately 1717) will receive saline placebo
Receives: Drug: Placebo
Sub-study AZD7442 Arm 1ExperimentalApproximately 500 participants will receive AZD7442 in the repeat dose sub-study. -Sub-study Arm 1 (~ 12 month repeat dose interval): Participants who received AZD7442 300 mg IM on Day 1 of the parent study will receive a second dose of AZD7442 300mg IM on sub-study Day 1.
Receives: Drug: AZD7442
Sub-study AZD7442 Arm 2ExperimentalApproximately 500 participants will receive AZD7442 in the repeat dose sub-study. -Sub-study Arm 2(~ 6 month repeat dose interval): Participants who received placebo on Day 1 of the parent study will receive their first dose of AZD7442 300mg IM on sub-study Day1 followed by a second dose on sub-study Day 183.
Receives: Drug: AZD7442
Sub-study AZD7442 Arm 3ExperimentalA subset of Arm 1 and Arm 2 participants who will receive additional doses of AZD7442, 600mg, at Day 183 and Day 366 of the sub-study.
Receives: Drug: AZD7442

What is being measured

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

  1. Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness

    To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19 prior to Day 183. Planned to be evaluated through Day 183, however, the number of events required for the primary endpoint was achieved 165 days after the study start date which is displayed in the primary efficacy row below. Final analysis is final data from the study based on the pre-planned 183 days of follow up for this endpoint.

    Measured: 165 Days for primary analysis, 183 days for final analysis

  2. AEs, SAEs, MAAEs, and AESIs Post Dose of IMP

    To assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo

    Measured: 457 Days, Final analysis

Secondary outcomes (5)

  1. The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARS-CoV-2 Nucleocapsid Antibodies.

    To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of SARS-CoV-2 infection

    Measured: 366 days

  2. The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP

    To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of severe or critical symptomatic COVID-19

    Measured: 366 Days

  3. The Incidence of COVID-19-related Emergency Department Visits Occurring After Dosing With IMP

    To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19-related Emergency Department visits

    Measured: 366 days

  4. Serum AZD7442 Concentrations, PK Parameters if Data Permit.

    To assess the pharmacokinetics of AZD7442 administered as a single dose of 300 mg IM

    Measured: 457 days

  5. Incidence of ADA to AZD7442 in Serum

    To evaluate ADA responses to AZD7442 in serum

    Measured: 457 days

Timeline

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

  1. First posted12 Nov 2020
  2. Study start21 Nov 2020
  3. Primary completion16 Aug 2022
  4. Study completion8 Dec 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
5,197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04625725
Sponsor's protocol ID
D8850C00002
Other IDs
2020-004356-16
Acronym
PROVENT
Status last verified
Dec 2024
First submitted
10 Nov 2020
Last updated
31 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Publications

  • Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.

    PubMed 30280658

  • CDC. (Centers for Disease Control and Prevention). Coronavirus Disease 2019 (COVID-19), Symptoms of Coronavrus. https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html. Published 2020. Accessed 01 July 2020.

  • Domachowske JB, Khan AA, Esser MT, Jensen K, Takas T, Villafana T, Dubovsky F, Griffin MP. Safety, Tolerability and Pharmacokinetics of MEDI8897, an Extended Half-life Single-dose Respiratory Syncytial Virus Prefusion F-targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants. Pediatr Infect Dis J. 2018 Sep;37(9):886-892. doi: 10.1097/INF.0000000000001916.

    PubMed 29373476

  • Furer V, Rondaan C, Heijstek MW, Agmon-Levin N, van Assen S, Bijl M, Breedveld FC, D'Amelio R, Dougados M, Kapetanovic MC, van Laar JM, de Thurah A, Landewe RB, Molto A, Muller-Ladner U, Schreiber K, Smolar L, Walker J, Warnatz K, Wulffraat NM, Elkayam O. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2020 Jan;79(1):39-52. doi: 10.1136/annrheumdis-2019-215882. Epub 2019 Aug 14.

    PubMed 31413005

  • Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.

    PubMed 32123347

  • Griffin MP, Khan AA, Esser MT, Jensen K, Takas T, Kankam MK, Villafana T, Dubovsky F. Safety, Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, in Healthy Adults. Antimicrob Agents Chemother. 2017 Feb 23;61(3):e01714-16. doi: 10.1128/AAC.01714-16. Print 2017 Mar.

    PubMed 27956428

  • Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, Simoes EAF, Esser MT, Khan AA, Dubovsky F, Villafana T, DeVincenzo JP; Nirsevimab Study Group. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. N Engl J Med. 2020 Jul 30;383(5):415-425. doi: 10.1056/NEJMoa1913556.

    PubMed 32726528

  • Lamb EJ, Levey AS, Stevens PE. The Kidney Disease Improving Global Outcomes (KDIGO) guideline update for chronic kidney disease: evolution not revolution. Clin Chem. 2013 Mar;59(3):462-5. doi: 10.1373/clinchem.2012.184259. No abstract available.

    PubMed 23449698

  • Li F. Structure, Function, and Evolution of Coronavirus Spike Proteins. Annu Rev Virol. 2016 Sep 29;3(1):237-261. doi: 10.1146/annurev-virology-110615-042301. Epub 2016 Aug 25.

    PubMed 27578435

  • Morand EF, Furie RA. Anifrolumab in Systemic Lupus Erythematosus. Reply. N Engl J Med. 2020 Apr 23;382(17):1666. doi: 10.1056/NEJMc2002191. No abstract available.

    PubMed 32320577

  • Poland GA, Ovsyannikova IG, Kennedy RB. Personalized vaccinology: A review. Vaccine. 2018 Aug 28;36(36):5350-5357. doi: 10.1016/j.vaccine.2017.07.062. Epub 2017 Jul 31.

    PubMed 28774561

  • Robbie GJ, Criste R, Dall'acqua WF, Jensen K, Patel NK, Losonsky GA, Griffin MP. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013 Dec;57(12):6147-53. doi: 10.1128/AAC.01285-13. Epub 2013 Sep 30.

    PubMed 24080653

  • Wagner A, Weinberger B. Vaccines to Prevent Infectious Diseases in the Older Population: Immunological Challenges and Future Perspectives. Front Immunol. 2020 Apr 23;11:717. doi: 10.3389/fimmu.2020.00717. eCollection 2020.

    PubMed 32391017

  • WHO. WHO Coronavirus Disease (COVID-19) Dashboard. 2020a.

  • WHO. WHO R&D Blueprint COVID-19 Therapeutic Trial Synopsis Draft 18 February 2020. https://www.who.int/blueprint/priority-diseases/key-action/COVID19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf. Published 2020b. Accessed 25 September 2020.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AZD7442 in people with COVID-19, run by AstraZeneca at 89 sites in 5 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 12 inclusion and 17 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 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, France, United Kingdom, Belgium, Spain. 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 20 Dec 2022). 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 First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness (time frame: 165 Days for primary analysis, 183 days for final analysis). 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 NCT04625725, which also lists 23 linked publications.

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 31 Dec 2024.

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