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Monoclonal Antibodies

AZD7442 for COVID-19 (PROVENT Trial)

Phase 3
Waitlist Available
Led By Myron Levin, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Can benefit from passive immunization with antibodies
Contraceptive used by women of child bearing potential, condom used by men
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

PROVENT Trial Summary

This trial will study if a single dose of AZD7442 can prevent COVID-19, and if it is safe.

Eligible Conditions
  • COVID-19
  • Coronavirus

PROVENT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are able to receive treatment with antibodies to help your immune system fight an infection or disease.
Select...
Women who are able to get pregnant must use birth control and men must use condoms.
Select...
Your immune system is weakened, or you might not respond well to a COVID-19 vaccine.
Select...
You can receive treatment with antibodies to boost your immune system.
Select...
Women who can have children must use birth control, and men must use condoms.
Select...
If any of the following situations apply to you:
Select...
You have a weakened immune system and may not respond well to the COVID-19 vaccine.

PROVENT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness
Secondary outcome measures
Incidence of ADA to AZD7442 in serum.
Serum AZD7442 concentrations, PK parameters if data permit.
The incidence of COVID-19-related Emergency Department visits occurring after dosing with IMP
+2 more
Other outcome measures
Sub-study Primary Endpoint: AEs, SAEs, MAAEs and AESIs post repeat dose of IMP.
Sub-study Secondary Endpoint: Incidence of ADA to repeat doses of AZD7442 in serum
Sub-study Secondary Endpoint: Post dose GMTs and GMFRs from baseline values after a repeat IM dose in SARS-CoV-2 nAbs (wild-type assay or pseudo-neutralization assay)
+1 more

Side effects data

From 2022 Phase 3 trial • 1131 Patients • NCT04625972
16%
Covid-19
11%
Cough
11%
Headache
8%
Oropharyngeal pain
8%
Rhinorrhoea
8%
Fatigue
7%
Nasal congestion
6%
Pyrexia
5%
Pain
4%
Chills
4%
Dyspnoea
3%
Urinary tract infection
3%
Myalgia
3%
Diarrhoea
3%
Nausea
2%
Nasopharyngitis
2%
Arthralgia
2%
Anosmia
2%
Upper respiratory tract infection
2%
Blood creatine phosphokinase increased
2%
Ageusia
2%
Sinus congestion
1%
Dehydration
1%
Anxiety
1%
Sinusitis
1%
Otitis media
1%
Influenza like illness
1%
Bronchitis
1%
Vaccination complication
1%
Asymptomatic covid-19
1%
Fall
1%
Aspartate aminotransferase increased
1%
Blood glucose increased
1%
Gamma-glutamyltransferase increased
1%
White blood cells urine positive
1%
Decreased appetite
1%
Type 2 diabetes mellitus
1%
Epistaxis
1%
Anaemia
1%
Back pain
1%
Muscle spasms
1%
Proteinuria
1%
Pain in extremity
1%
Dizziness
1%
Hypertension
1%
Malaise
1%
C-reactive protein increased
1%
Dyspepsia
1%
Toothache
1%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AZD7442

PROVENT Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Sub-study AZD7442 Arm 3Experimental Treatment1 Intervention
A 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.
Group II: Sub-study AZD7442 Arm 2Experimental Treatment1 Intervention
Approximately 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.
Group III: Sub-study AZD7442 Arm 1Experimental Treatment1 Intervention
Approximately 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.
Group IV: AZD7442Experimental Treatment1 Intervention
Approximately 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
Group V: PlaceboPlacebo Group1 Intervention
Approximately 5150 participants will be randomized in a 2:1 ratio • Arm 2 (n=approximately 1717) will receive saline placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD7442
2020
Completed Phase 3
~6640

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,466,167 Total Patients Enrolled
52 Trials studying COVID-19
256,192,237 Patients Enrolled for COVID-19
Iqvia Pty LtdIndustry Sponsor
106 Previous Clinical Trials
164,754 Total Patients Enrolled
7 Trials studying COVID-19
95,015 Patients Enrolled for COVID-19
Myron Levin, MDPrincipal InvestigatorAstraZeneca
4 Previous Clinical Trials
1,293 Total Patients Enrolled
1 Trials studying COVID-19
1,131 Patients Enrolled for COVID-19

Media Library

AZD7442 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04625725 — Phase 3
COVID-19 Research Study Groups: Sub-study AZD7442 Arm 3, Placebo, AZD7442, Sub-study AZD7442 Arm 1, Sub-study AZD7442 Arm 2
COVID-19 Clinical Trial 2023: AZD7442 Highlights & Side Effects. Trial Name: NCT04625725 — Phase 3
AZD7442 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04625725 — Phase 3
COVID-19 Patient Testimony for trial: Trial Name: NCT04625725 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary goal of this research?

"The primary objective of this study, which will be measured over a 457 day period, is to assess the incidence of the first case of SARS CoV-2 RT PCR positive symptomatic illness. Additionally, this trial will also collect data on secondary outcomes including 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, The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring after dosing with IMP, and Serum AZD7442 concentrations"

Answered by AI

Are enrolment numbers still open for this research project?

"According to the latest information found on clinicaltrials.gov, this study is not currently recruiting patients for participation. The trial was first posted on November 21st, 2020 and was last updated on January 20th, 2022. Although this specific trial isn't searching for candidates, there are 1,131 other studies that are actively recruiting right now."

Answered by AI

In how many different hospitals is this trial taking place?

"Currently, this clinical trial is being conducted at 52 sites. A few locations include Noblesville, Evansville and Lauderdale Lakes but there are many more. Minimizing travel burden is an important factor to consider when selecting a location, so please choose the site closest to you."

Answered by AI

How big is the sample size for this clinical trial?

"Unfortunately, this particular clinical trial is no longer actively recruiting patients. The listing was created on November 21st 2020 and last updated January 20th 2022. If you are still interested in participating in studies related to covid-19, there are 1126 active listings enrolling participants and 5 trials for AZD7442 that have open recruitment."

Answered by AI

Who qualifies to participate in this research?

"This ongoing clinical trial is looking for 5197 patients who currently have covid-19 and are between the ages of 18 and 120. In order to be eligible, patients must also meet the following criteria: they can benefit from passive immunization with antibodies, they are medically stable, they have a 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 The participant has been randomized, dosed, and is ongoing in the PROV"

Answered by AI

What is the FDA's stance on AZD7442?

"There is both preclinical and clinical data supporting the safety of AZD7442, so it received a score of 3."

Answered by AI

Does this research program have an age limit for participants?

"The age limit for participants in this study is 120 years old, with a minimum age of 18."

Answered by AI

What does the research say about AZD7442 so far?

"There are five clinical studies currently underway for AZD7442, four of which have reached Phase 3. Trials for this medication are being conducted at 598 different facilities, with a notable concentration in Anniston, Alabama."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Alabama
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
2
0

What questions have other patients asked about this trial?

How long does screening visits take and location near me? How long is the screening process. And is this a paid trial?
PatientReceived 2+ prior treatments
Do test subjects need to have an active covid-19 illness? Is the goal of this study to test efficacy/safety for active illness or simply physiological responses to the medication?
PatientReceived no prior treatments

Why did patients apply to this trial?

I need a booster. Looking to do the study. Want to help in the fight against Covid-19.
PatientReceived no prior treatments
I have All the vaccinations and booster ones. I want to be helpful, and enjoy helping make the world a better place.
PatientReceived no prior treatments
Recent research and studies
~1212 spots leftby Mar 2025