Tenon Hospital APHP dermatology and allergology department
Paris, 75020, France
NCT Number: NCT05028257
Prospective and retrospective multicenter study to estimate the proportion of patients who tolerated continuation of COVID-19 vaccination (absence of anaphylactic manifestations).
secondly, to determine the proportion of definite anaphylactic reactions in cases of suspected anaphylaxis following administration of a COVID-19 vaccine.
Comprehensive allergological investigations involving clinical, skin and biological tests will enable us to determine whether or not vaccine components, and in particular excipients (PEG2000, PS80 and tromethamine), are responsible for anaphylactic reactions to COVID-19 vaccines.
A biological collection will be set up during this clinical study to study the immunological mechanisms, effector cells and signalling pathways involved in these reactions.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Paris, 75020, France
Eligible patients will be identified via the pharmacovigilance centers and allergology hotlines set up in each center, according to the organization specific to each hospital site. .
The patient identified in this way will be contacted by the secretariat of each allergology center to schedule an allergology consultation at least 3 to 5 weeks after the reaction (the usual delay before exploring an anaphylactic reaction to avoid the risk of false negatives). Then, in the framework of a collegial meeting ,the patient's file will be reviewed in order to specify the history of the allergic disease and the modalities of subsequent COVID-19 vaccination.
A follow-up telephonique call at 6months will be made systematically for patients who have continued vaccination to ensure that there are no significant adverse events related to the COVID-19 vaccine.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
An anaphylactic reaction is defined as the occurrence of any of the following systemic manifestations within a few hours of administration of a COVID-19 vaccine:
Exclusion criteria
Pursuit of vaccination in case of anaphylactic reaction
Other names: Janssen COVID19 vaccine, Astra Zeneca COVID19 vaccine, Comirnaty Pfizer COVID19 vaccine, Moderna COVID19 vaccine
Time frame: from Week 9 to Month 9
Proportion of patient without anaphylactic reaction during second vaccination
Time frame: from Week 9 to Month 9
Proportion of patient with positive skin tests for excipients (PEG2000, PS80) or COVID-19 vaccines
Time frame: from Week 9 to Month 9
Proportion of patient with positive allergological explorations (anamnesis, skin tests or biological test for excipients or vaccines)
Assistance Publique - Hôpitaux de Paris
Other
Pursuit of Vaccination in Anaphylactic Reaction to COVID19 Vaccines
Acronym: COVALL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06065137
Allergic Reaction, Anaphylactic Reaction
Edegem, Antwerp, Belgium
View Trial DetailsNCT06205134
Anaphylactic Reaction, Anaphylaxis
Jerusalem, Israel
View Trial DetailsNCT06013150
Anaphylactic Reaction, Anaphylaxis
Adelaide, South Australia, Australia
View Trial DetailsNCT06405399
Anaphylactic Reaction, Anaphylaxis
Pamplona, Navarre, Spain
View Trial Details