CoV2 Positive Caregivers Clinical Trial
— COVID-SEROfficial title:
Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER
| Verified date | May 2024 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests
| Status | Active, not recruiting |
| Enrollment | 550 |
| Est. completion date | October 10, 2026 |
| Est. primary completion date | April 10, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Seropositive caregivers screened for anti-SARS CoV2 antibodies during their consultation at the occupational medicine of HCL. - Age: = 18 years old - Persons having given their written consent and accepting a follow-up every 6 months for 24 months, followed by a final visit at 36 months. - Persons affiliated to a social security scheme or beneficiary of such a scheme. Exclusion Criteria: - Pregnant or lactating woman |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Lyon Sud,Sainte Eugénie bat 4M,5, Chemin du Grand Revoyet | Pierre-Bénite cedex |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
Bal A, Brengel-Pesce K, Gaymard A, Queromes G, Guibert N, Frobert E, Bouscambert M, Trabaud MA, Allantaz-Frager F, Oriol G, Cheynet V, d'Aubarede C, Massardier-Pilonchery A, Buisson M, Lupo J, Pozzetto B, Poignard P, Lina B, Fassier JB, Morfin F, Trouille — View Citation
Bal A, Pozzetto B, Trabaud MA, Escuret V, Rabilloud M, Langlois-Jacques C, Paul A, Guibert N, D'Aubarede-Frieh C, Massardier-Pilonchery A, Fabien N, Goncalves D, Boibieux A, Morfin-Sherpa F, Pitiot V, Gueyffier F, Lina B, Fassier JB, Trouillet-Assant S; C — View Citation
Bal A, Trabaud MA, Fassier JB, Rabilloud M, Saker K, Langlois-Jacques C, Guibert N, Paul A, Alfaiate D, Massardier-Pilonchery A, Pitiot V, Morfin-Sherpa F, Lina B, Pozzetto B, Trouillet-Assant S; COVID SER Study Group. Six-month antibody response to SARS- — View Citation
de Boer J, Saade U, Granjon E, Trouillet-Assant S, Saade C, Pottel H, Zrein M; Covid ser study group. A novel assessment method for COVID-19 humoral immunity duration using serial measurements in naturally infected and vaccinated subjects. PLoS One. 2022 — View Citation
Pozzetto B, Legros V, Djebali S, Barateau V, Guibert N, Villard M, Peyrot L, Allatif O, Fassier JB, Massardier-Pilonchery A, Brengel-Pesce K, Yaugel-Novoa M, Denolly S, Boson B, Bourlet T, Bal A, Valette M, Andrieu T, Lina B; Covid-Ser study group; Cosset — View Citation
Trouillet-Assant S, Albert Vega C, Bal A, Nazare JA, Fascia P, Paul A, Massardier-Pilonchery A, D Aubarede C, Guibert N, Pitiot V, Lahousse M, Boibieux A, Makhloufi D, Simon C, Rabilloud M, Trabaud MA, Gueyffier F, Fassier JB; COVID-SER study group. Asses — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 0 | |
| Primary | The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 3 | |
| Primary | The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 7 | |
| Primary | The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 14 | |
| Primary | The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 21 | |
| Primary | The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 28 | |
| Primary | The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 35 | |
| Primary | The positivity (Yes/No) of the serological test. | The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR | Day 42 |