Anaphylactic ReactionPhase 3COVALLNCT05028257
Allergy and COVID-19 Vaccines
A Phase 3 study testing COVID-19 Vaccines in people with Anaphylactic Reaction and Vaccine Reaction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Prospective and retrospective multicenter study to estimate the proportion of patients who tolerated continuation of COVID-19 vaccination (absence of anaphylactic manifestations). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaphylactic Reaction, Vaccine Reaction
- What is being tested?
- COVID-19 Vaccines
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2021to 22 May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Anaphylactic reaction to a COVID-19 vaccine administered by Pfizer-BioNtech or Janssen or Vaxzevria or Moderna, at least 3 weeks old at the time of the allergology consultation.
- 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:
- skin rash with urticaria and/or angiodema,
- and/or associated with respiratory signs (dyspnea, bronchospasm, desaturation), and/or digestive disorders (intense abdominal pain, diarrhea, vomiting, nausea), and/or neurological disorders (loss of consciousness, feeling of malaise), 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Tenon Hospital APHP dermatology and allergology department
Paris, 75020
About this study
Official title: Pursuit of Vaccination in Anaphylactic Reaction to COVID19 Vaccines
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Anaphylactic Reaction, Vaccine Reaction
- Being tested
- COVID-19 Vaccines
- Keywords
- Anaphylactic reactions, COVID-19 vaccines, PEG2000, tromethamine
- Medical subject headings
- Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccinesBiological
Also called Janssen COVID19 vaccine, Astra Zeneca COVID19 vaccine, Comirnaty Pfizer COVID19 vaccine, Moderna COVID19 vaccine
Pursuit of vaccination in case of anaphylactic reaction
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Vaccinated Patients | Experimental | Not described Receives: Biological: COVID-19 Vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the continuation of vaccination and its tolerance in case of negative allergological investigation.
Proportion of patient without anaphylactic reaction during second vaccination
Measured: from Week 9 to Month 9
Secondary outcomes (2)
Determine the involvement of excipients in anaphylactic reactions
Proportion of patient with positive skin tests for excipients (PEG2000, PS80) or COVID-19 vaccines
Measured: from Week 9 to Month 9
To determine with certainty the diagnosis of anaphylaxis in the face of a suspected anaphylactic reaction during the administration of a COVID-19 vaccine.
Proportion of patient with positive allergological explorations (anamnesis, skin tests or biological test for excipients or vaccines)
Measured: from Week 9 to Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start15 Sep 2021
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anaphylactic ReactionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angèle SORIA, PUPH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028257
- Sponsor's protocol ID
- P 210641
- Other IDs
- 2021-003155-42
- Acronym
- COVALL
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nicaise-Roland P, Granger V, Soria A, Barbaud A, Pallardy M, Chollet-Martin S, de Chaisemartin L. Immediate hypersensitivity to COVID-19 vaccines: Focus on biological diagnosis. Front Allergy. 2022 Sep 30;3:1007602. doi: 10.3389/falgy.2022.1007602. eCollection 2022.
PubMed 36249342de Chaisemartin L, Diep A, Gonnin C, Soria A, Barbaud A, Nicaise-Roland P. Immune parameters during anaphylaxis to messenger RNA coronavirus disease 2019 vaccines: Not the usual suspects? Ann Allergy Asthma Immunol. 2022 Mar;128(3):338-339. doi: 10.1016/j.anai.2021.11.012. No abstract available.
PubMed 35216744Soria A, Labella M, Dona I, Nicaise-Roland P, Chollet-Martin S, Autegarden JE, Castagna J, Le Thai C, de Chaisemartin L, Torres MJ, Barbaud A. Risk stratification through extensive allergy work-up in COVID-19-mRNA vaccine allergic reactions. Allergy. 2023 Aug;78(8):2320-2323. doi: 10.1111/all.15715. Epub 2023 Mar 27. No abstract available.
PubMed 36971457
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pursuit of Vaccination in Anaphylactic Reaction to COVID19 Vaccines
- ClinicalTrials.gov ID
- NCT05028257
- Acronym / sponsor ID
- COVALL / P 210641
- Conditions
- Anaphylactic Reaction, Vaccine Reaction
- Keywords
- Anaphylactic reactions, COVID-19 vaccines, PEG2000, tromethamine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Vaccinated Patients | Experimental | Biological: COVID-19 Vaccines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Anaphylactic reaction to a COVID-19 vaccine administered by Pfizer-BioNtech or Janssen or Vaxzevria or Moderna, at least 3 weeks old at the time of the allergology consultation.
- 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:
- skin rash with urticaria and/or angiodema,
- and/or associated with respiratory signs (dyspnea, bronchospasm, desaturation), and/or digestive disorders (intense abdominal pain, diarrhea, vomiting, nausea), and/or neurological disorders (loss of consciousness, feeling of malaise), and/or hypotension, tachycardia.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 VaccinesAlso: Janssen COVID19 vaccine, Astra Zeneca COVID19 vaccine, Comirnaty Pfizer COVID19 vaccine, Moderna COVID19 vaccinePursuit of vaccination in case of anaphylactic reaction | Biological | COVID-19 Vaccinated Patients |
Primary outcome
Describe the continuation of vaccination and its tolerance in case of negative allergological investigation.
Time frame: from Week 9 to Month 9
Proportion of patient without anaphylactic reaction during second vaccination
2 secondary outcomes
Determine the involvement of excipients in anaphylactic reactions
Time frame: from Week 9 to Month 9
To determine with certainty the diagnosis of anaphylaxis in the face of a suspected anaphylactic reaction during the administration of a COVID-19 vaccine.
Time frame: from Week 9 to Month 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Results publication: PubMed 36249342Nicaise-Roland P, Granger V, Soria A, Barbaud A, Pallardy M, Chollet-Martin S, de Chaisemartin L. Immediate hypersensitivity to COVID-19 vaccines: Focus on biological diagnosis. Front Allergy. 2022 Sep 30;3:1007602. doi: 10.3389/falgy.2022.1007602. eCollection 2022.
- Results publication: PubMed 35216744de Chaisemartin L, Diep A, Gonnin C, Soria A, Barbaud A, Nicaise-Roland P. Immune parameters during anaphylaxis to messenger RNA coronavirus disease 2019 vaccines: Not the usual suspects? Ann Allergy Asthma Immunol. 2022 Mar;128(3):338-339. doi: 10.1016/j.anai.2021.11.012. No abstract available.
- Results publication: PubMed 36971457Soria A, Labella M, Dona I, Nicaise-Roland P, Chollet-Martin S, Autegarden JE, Castagna J, Le Thai C, de Chaisemartin L, Torres MJ, Barbaud A. Risk stratification through extensive allergy work-up in COVID-19-mRNA vaccine allergic reactions. Allergy. 2023 Aug;78(8):2320-2323. doi: 10.1111/all.15715. Epub 2023 Mar 27. No abstract available.
Related trials for Anaphylactic Reaction
Active, not recruitingPhase 2
A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
Peanut Allergy, Peanut Hypersensitivity
RecruitingObservational study
Maximum Lysis on Thromboelastography as a Marker of Systemic Severity in Acute Allergic Reactions
Allergy, Allergic Reactions
Not yet recruitingPhase 2
Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients
Epinephrine, Hypersensitivity, Immediate
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
RecruitingObservational study
Post-market Safety Study of LUMISIGHT
Hypersensitivity Reactions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angèle SORIA, PUPH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing COVID-19 Vaccines in people with Anaphylactic Reaction and Vaccine Reaction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the continuation of vaccination and its tolerance in case of negative allergological investigation. (time frame: from Week 9 to Month 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05028257, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.