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| Column | Value |
|---|---|
| Trial registration number | NCT05655351 |
|
Full text link
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
pierre.corbeau@chu-nimes.fr |
|
Registration date
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
2022-12-19 |
|
Recruitment status
Last imported at : Feb. 13, 2023, 8:44 a.m. Source : ClinicalTrials.gov |
Recruiting |
|
Study design
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
Non-randomized |
|
Design
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
Single group assignment |
|
Masking
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
inclusion criteria: candidate for sars-cov-2 vaccination with an mrna vaccine (pfizer, moderna). subject has given free and informed consent. subject who has signed the consent form. person affiliated to or beneficiary of a health insurance plan. |
|
Exclusion criteria
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
patients under treatment with n-acetylcysteine or sartan. patients with a dysimmune pathology or immunosuppressive treatment. person infected with sars-cov-2 within 3 months prior to inclusion. person participating in a category 1 defined riph. subject in an exclusion period as determined by another study. person under court protection, guardianship or trusteeship. subject who is unable to give consent. subject for whom it is impossible to give clear information. pregnant or breastfeeding woman. |
|
Number of arms
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
1 |
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Funding
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
Centre Hospitalier Universitaire de Nīmes |
|
Inclusion age min
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Feb. 13, 2023, 8:44 a.m. Source : ClinicalTrials.gov |
France |
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Type of patients
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
30 |
|
primary outcome
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged 30 - 60 after anti-SARS-CoV-2 vaccination with an mRNA vaccine.;Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged 30 - 60 after anti-SARS-CoV-2 vaccination with an mRNA vaccine.;Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged 30 - 60 after anti-SARS-CoV-2 vaccination with an mRNA vaccine.;Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged 30 - 60 before anti-SARS-CoV-2 vaccination with an mRNA vaccine.;Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged over 60 after anti-SARS-CoV-2 vaccination with an mRNA vaccine.;Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged over 60 after anti-SARS-CoV-2 vaccination with an mRNA vaccine.;Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged over 60 after anti-SARS-CoV-2 vaccination with an mRNA vaccine.;Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients aged over 60 before anti-SARS-CoV-2 vaccination with an mRNA vaccine.;Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients under 30 years old after anti-SARS-CoV-2 vaccination with an mRNA vaccine.;Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients under 30 years old after anti-SARS-CoV-2 vaccination with an mRNA vaccine.;Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients under 30 years old after anti-SARS-CoV-2 vaccination with an mRNA vaccine.;Monocyte production of oxygenated derivatives (Reactive oxygen species) in patients under 30 years old before anti-SARS-CoV-2 vaccination with an mRNA vaccine. |
|
Notes
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
Phase 1 |
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Arms
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "mRNA vaccine (Pfizer, Moderna)", "treatment_id": 831, "treatment_name": "Mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |