Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult. (PROVENT)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04625725 |
Recruitment Status :
Active, not recruiting
First Posted : November 12, 2020
Last Update Posted : April 8, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: AZD7442 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5247 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
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. |
Actual Study Start Date : | November 21, 2020 |
Estimated Primary Completion Date : | April 21, 2021 |
Estimated Study Completion Date : | June 22, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: AZD7442
Approximately 5000 participants will be randomized in a 2:1 ratio • Arm 1 (n=approximately 3333) will receive a single dose (× 2IM injections) of 300 mg of AZD7442 |
Drug: AZD7442
Single dose (× 2IM injections) of either 300 mg of AZD7442 or saline placebo on Day 1.
Other Name: Combination of 2mAbs(AZD8895and AZD1061) |
Placebo Comparator: Placebo
Approximately 5000 participants will be randomized in a 2:1 ratio • Arm 2 (n=approximately 1667) will receive saline placebo |
Drug: Placebo
Single dose (× 2IM injections) of either 300 mg of AZD7442 or saline placebo on Day 1. |
- The incidence of the first case of SARS CoV-2 RT PCR positive symptomatic illness [ Time Frame: Day 183 ]To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19 through Day 183
- AEs, SAEs, MAAEs, and AESIs through 365 days post dose of IMP [ Time Frame: 1 year ]To assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo
- The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring after dosing with IMP through Day 366 [ Time Frame: 1 year ]To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19 through Day 366
- 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 [ Time Frame: 1 year ]To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of SARS-CoV-2 infection
- The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring after dosing with IMP [ Time Frame: 1 year ]To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of severe or critical symptomatic COVID-19
- The incidence of COVID-19-related Emergency Department visits occurring after dosing with IMP [ Time Frame: 1 year ]To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19-related Emergency Department visits
- Serum AZD7442 concentrations, PK parameters if data permit. [ Time Frame: 1 year ]To assess the pharmacokinetics of AZD7442 administered as a single dose of 300 mg IM
- Incidence of ADA to AZD7442 in serum. [ Time Frame: 1 year ]To evaluate ADA responses to AZD7442 in serum

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥ 18 years of age at the time of signing the informed consent
- Can benefit from passive immunization with antibodies
- Medically stable
- Contraceptive used by women of child bearing potential, condom used by men
Exclusion Criteria:
- 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.
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625725

Principal Investigator: | Myron Levin, MD | AstraZeneca |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT04625725 |
Other Study ID Numbers: |
D8850C00002 |
First Posted: | November 12, 2020 Key Record Dates |
Last Update Posted: | April 8, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Time Frame: | AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
Access Criteria: | When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure |
URL: | https://astrazenecagroup-dt.pharmacm.com/DT/Home |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pre-exposure Prophylaxis of COVID-19 |