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Column | Value |
---|---|
Trial registration number | EUCTR2020-001678-31-FR |
Full text link
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001678-31/FR |
First author
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
|
Contact
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
moufida.dabbech@aphp.fr |
Registration date
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
2020-04-17 |
Recruitment status
Last imported at : Feb. 7, 2024, 8 p.m. Source : EU Clinical Trials Register |
Completed |
Study design
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
RCT |
Allocation
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Randomized |
Design
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Parallel |
Masking
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Blind label |
Center
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
multi-center |
Study aim
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Prevention |
Inclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
-Individual (Male and female) aged 18 or over. -Healthcare Worker (medical or non-medical) from hospitals in direct -contact with COVID-19 patients. -Participants must give their written consent before any trial procedure. -Participants covered by social security regimen (excepting AME). -Healthy according to the opinion of the investigator. 1. Homme ou femme âgé(e) de 18 ans ou plus 2. Personnel soignant (médical ou non médical) en contact direct avec les patients COVID-19 3. Ayant donné leur consentement écrit avant toute procédure d'essai. 4. Couverture par un régime de sécurité sociale ou équivalent. 5. En bonne santé selon l’opinion de l’investigateur |
Exclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
-Has any BCG vaccine contraindication, known allergy to the BCG vaccine or SAE to prior BCG vaccination. -History of tuberculosis -People with acquired or innate immunodeficiency. -People have already been infected with SARS Cov-2 (virological documentation or TDM or seropositive if serology available). -People who could not commit to follow-up for 6 months. -People not in good general condition, as assessed by the investigator. -People included in other therapeutic clinical trials assessing treatment -Pregnant or breastfeeding at enrolment visit. -BCG vaccine given within the last year. -Another live vaccine administered in the month prior to randomization. -History of anaphylaxis following vaccination. -Receiving medical treatment that affects the immune response or other immunosuppressive therapy in the last year. These therapies include systemic corticosteroids (more than or equal to 10 mg for more than or equal to 2 weeks), immunosuppressant, biological agents (such as monoclonal antibodies against tumour necrosis factor (TNF)-alpha). -Another vaccine administered in the month prior to inclusion and randomization. - Fever > 38°C within the past 24 hours - People under legal protection measure (tutorship) 1. Antécédents de contre-indication au BCG, allergie connue au BCG ou EIG à une vaccination BCG préalable. 2. ATCD de tuberculose. 3. Personnes présentant une immuno-déficience acquise ou innée 4. Personnes ayant déjà été infectées par le SARS Cov-2 (documentation virologique ou TDM ou sérologie positive quand la sérologie sera faisable) 5. Personnes qui ne pourraient pas s’engager sur le suivi de 6 mois 6. Personnes n’étant pas en bonne condition générale, jugé par l’investigateur 7. Personnes incluses dans d’autres essais cliniques évaluant des traitements 8. Grossesse, allaitement ou test de grossesse positif le jour de l'inclusion. 9. Vacciné avec le BCG dans l’année précédente 10. Vacciné avec un autre vaccin vivant dans le mois avant la randomisation 11. Antécédents d'anaphylaxie après une vaccination. 12. Ayant reçu un traitement médical qui affecte la réponse immune ou autre thérapie immunosuppressive dans l’année précédente. Ces thérapies incluent des corticostéroïdes systémiques (supérieurs ou égaux à 10 mg pendant 2 semaines ou plus), des immunosuppresseurs, des agents biologiques (tels que des anticorps monoclonaux contre le facteur de nécrose tumorale (TNF) -alpha). 13. Ayant reçu un autre vaccin dans les 4 semaines précédentes 14. Fièvre> 38 ° C au cours des dernières 24 heures. 15. Personne sous mesure de protection juridique (tutelle) |
Number of arms
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
2 |
Funding
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Assistance Publique Hopitaux de Paris |
Inclusion age min
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
18 |
Inclusion age max
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
100 |
Countries
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
France |
Type of patients
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Health workers |
Severity scale
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
N/A |
Total sample size
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
1120 |
primary outcome
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Documented COVID-19, i.e. - symptomatic COVID-19 confirmed by either positive nasopharyngeal tests for SARS CoV2 and/or by thoracic tomodensitometry compatible with the diagnosis. - and/or SARS CoV2 seroconversion during the study period of 6 months. Proportion des participants ayant un diagnostic de COVID 19 cliniquement symptomatique et confirmé par prélèvement nasopharyngé positif pour le SARS Cov-2 et/ou un prélèvement sanguin positif et /ou un TDM thorax compatible avec le diagnostic et/ou une séroconversion SARS Cov-2 durant la période de suivi de 6 mois. |
Notes
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Declared number of arm (3.0) differs from found arms (2.0) |
Phase
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Phase 3 |
Arms
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
[{"arm_notes": "1", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "1", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}] |