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AZD7442 for COVID-19 (PROVENT Trial)
PROVENT Trial Summary
This trial will study if a single dose of AZD7442 can prevent COVID-19, and if it is safe.
- COVID-19
- Coronavirus
PROVENT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 5197 Patients • NCT04625725PROVENT Trial Design
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Who is running the clinical trial?
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- You have had a past infection of SARS or MERS, which are severe respiratory illnesses.You have had a severe allergic or negative reaction after receiving a medication called a monoclonal antibody (mAb).You have a condition that causes excessive bleeding or bruising after getting shots or having blood drawn.You can receive treatment with antibodies to boost your immune system.Women who can have children must use birth control, and men must use condoms.If any of the following situations apply to you:You have a weakened immune system and may not respond well to the COVID-19 vaccine.
- Group 1: AZD7442
- Group 2: Sub-study AZD7442 Arm 3
- Group 3: Placebo
- Group 4: Sub-study AZD7442 Arm 1
- Group 5: Sub-study AZD7442 Arm 2
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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"
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."
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."
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."
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"
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."
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."
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."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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