CompletedNot Applicable

Evusheld Japan PMS_Japan Post-Marketing Surveillance (PMS)

Japan366 participantsStarted 2023-01-06

Plain-language summary

To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * For treatment of symptomatic disease caused by SARS-CoV-2 infection; Patients with risk factors for severe SARS-CoV-2 infection who do not require supplemental oxygen. * For prevention of symptomatic disease caused by SARS-CoV-2 infection; Individuals for whom SARS-CoV-2 vaccination is not recommended OR those who are considered to have an inadequate response to a COVID-19 vaccine due to immunodeficiencies AND who is not close contacts such as family members or other people living in the same dwelling as patients infected with SARS-CoV-2. Exclusion Criteria: * None

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of ADRs

Timeframe: 24weeks(6 months)

Trial details

NCT IDNCT05687877

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-01-20

View on ClinicalTrials.gov More SARS-CoV-2 Infection trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.