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Allergy and COVID-19 Vaccines (COVALL)

Primary Purpose

Anaphylactic Reaction, Vaccine Reaction

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

COVID-19 Vaccines

About this trial

This is an interventional treatment trial for Anaphylactic Reaction focused on measuring Anaphylactic reactions, COVID-19 vaccines, PEG2000, tromethamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

Tenon Hospital APHP dermatology and allergology departmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COVID-19 Vaccinated Patients

Arm Description

Outcomes

Primary Outcome Measures

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

Proportion of patient without anaphylactic reaction during second vaccination

Secondary Outcome Measures

Determine the involvement of excipients in anaphylactic reactions

Proportion of patient with positive skin tests for excipients (PEG2000, PS80) or COVID-19 vaccines

To determine with certainty the diagnosis of anaphylaxis in the face of a suspected anaphylactic reaction during the first administration of a COVID-19 vaccine.

Proportion of patient with positive allergological explorations (anamnesis, skin tests or biological test for excipients or vaccines)

Full Information

NCT ID

NCT05028257

First Posted

July 31, 2021

Last Updated

October 15, 2021

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT05028257

Brief Title

Allergy and COVID-19 Vaccines

Acronym

COVALL

Official Title

Pursuit of Vaccination in Anaphylactic Reaction to COVID19 Vaccines

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 15, 2021 (Actual)

Primary Completion Date

May 2022 (Anticipated)

Study Completion Date

May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Prospective monocentric study designed firstly to estimate the proportion of patients who tolerated the continuation of the COVID-19 2nd injection (absence of anaphylactic manifestations). secondly, to know the proportion of definite anaphylactic reactions in cases of suspected anaphylaxis after the first administration of a COVID-19 vaccine the very complete allergological explorations with both the clinical side, skin tests and biological tests will allow us to highlight the responsibility or not of the components of the vaccine,in particular of the excipients (PEG2000, PS80 and tromethamine) in anaphylactic reactions to COVID-19 vaccines A biological collection will be set up during this clinical study in order to study the immunological mechanisms; the effector cells and the signalling pathways involved in these reactions.

Detailed Description

Eligible patients who experience an anaphylactic reaction after the first COVID-19 vaccine injection as part of their routine vaccination will be identified through the hotline set up by our expert center. Three to five weeks after the anaphylactic reaction, the patients will be called for a consultation in the dermatology and allergology department of Tenon hospital for a complete allergological check-up. 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 received the 2nd dose of vaccine to ensure thatthere are no significant adverse events related to the COVID-19 vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anaphylactic Reaction, Vaccine Reaction

Keywords

Anaphylactic reactions, COVID-19 vaccines, PEG2000, tromethamine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

COVID-19 Vaccinated Patients

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

COVID-19 Vaccines

Other Intervention Name(s)

Janssen COVID19 vaccine, Astra Zeneca COVID19 vaccine, Comirnaty Pfizer COVID19 vaccine, Moderna COVID19 vaccine

Intervention Description

Pursuit of vaccination in case of anaphylactic reaction

Primary Outcome Measure Information:

Title

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

Description

Proportion of patient without anaphylactic reaction during second vaccination

Time Frame

from Week 9 to Month 9

Secondary Outcome Measure Information:

Title

Determine the involvement of excipients in anaphylactic reactions

Description

Proportion of patient with positive skin tests for excipients (PEG2000, PS80) or COVID-19 vaccines

Time Frame

from Week 9 to Month 9

Title

To determine with certainty the diagnosis of anaphylaxis in the face of a suspected anaphylactic reaction during the first administration of a COVID-19 vaccine.

Description

Proportion of patient with positive allergological explorations (anamnesis, skin tests or biological test for excipients or vaccines)

Time Frame

from Week 9 to Month 9

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Angèle SORIA, PUPH

Phone

0156017220

angele.soria@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Annick BARBAUD

Phone

0156017220

annick.barbaud@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angèle SORIA, PUPH

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tenon Hospital APHP dermatology and allergology department

City

Paris

ZIP/Postal Code

75020

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Angèle SORIA, PU-PH

Phone

0156017220

angele.soria@aphp.fr

First Name & Middle Initial & Last Name & Degree

Annick BARBAUD, PU-PH

Phone

0156017220

annick.barbaud@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

Allergy and COVID-19 Vaccines

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