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Trial - NCT05028257


Column Value
Trial registration number NCT05028257
Full text link
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05028257

First author
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Angèle SORIA, PUPH

Contact
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

angele.soria@aphp.fr

Registration date
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

2021-08-31

Recruitment status
Last imported at : Oct. 22, 2021, 10 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

nonRCT

Allocation
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Non-randomized

Design
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Single group assignment

Masking
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - age ≥ 18 years - anaphylactic reaction at least 3 weeks old prior to allergology consultation, when administered a covid-19 vaccine. anaphylactic reaction is defined as the occurrence within hours of administration of a covid-19 vaccine of any of the following systemic manifestations; skin rash such as urticaria and/or angiodema, associated with respiratory signs (dyspnea, bronchospasm, desaturation), and/or digestive disorders (severe abdominal pain, diarrhea, vomiting, nausea), and/or neurological disorders (loss of consciousness, feeling of faintness), and/or hypotension, tachycardia. - affiliation to a social security system - signature of the informed consent - stop taking antihistamines at least 3 days before skin allergy tests are performed

Exclusion criteria
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

- other non-anaphylactic systemic reactions after administration of covid-19 mrna vaccine (serum sickness, vasculitis, guillain-barré syndrome) - pregnancy and lactation - disorders of hemostasis or severe bleeding considered a contraindication to intramuscular injection

Number of arms
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Assistance Publique - Hôpitaux de Paris

Inclusion age min
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

France

Type of patients
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

120

primary outcome
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Describe the continuation of vaccination and its tolerance in case of negative allergological investigation.

Notes
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Sept. 1, 2021, 8:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "1;Anaphylactic reaction at least 3 weeks old prior to allergology consultation, when administered a COVID-19 vaccine.", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Anaphylactic reaction at least 3 weeks old prior to allergology consultation, when administered a COVID-19 vaccine.", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Anaphylactic reaction at least 3 weeks old prior to allergology consultation, when administered a COVID-19 vaccine.", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Anaphylactic reaction at least 3 weeks old prior to allergology consultation, when administered a COVID-19 vaccine.", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]