NCT04648709: COVIMMUNITY

Evaluation and Longitudinal Follow-up of Biomarkers Predictive of Severe Forms of COVID-19

Terminated Last updated 20 December 2023

What this trial tests

trial testing ELISPOT in Covid19 in 73 participants. Terminated before completion.

Timeline

9 March 2021

Primary endpoint
26 September 2022

11 December 2023

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Saint Etienne
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	73
Start date	9 March 2021
Primary completion	26 September 2022
Estimated completion	11 December 2023
Sites	1 location across France

Drugs / interventions tested

• ELISPOT
• QUANTIFERON

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Current data in the literature demonstrate that the immune response to CoV-2-SARS is much more complex than initially assumed. In fact, beyond the humoral response, including the existence of neutralizing CAs, the adaptive lymphocyte T-type immune response also appears to play an important role in controlling the infection and reducing the severity of the disease. At this stage, the analysis of this T response is still rudimentary and underdeveloped, but it seems crucial to be able to analyze it effectively in COVID-19 patients, which could help predict the evolution of the infection. It is also currently difficult to know the evolution of this response over time and especially after the resolution of the infection.

To this end, we will analyze the T lymphocyte response (ELISPOT and QUANTIFERON) based on the secretion of IFN (Th1) and IL-4 (Th2) by CoV-2-SARS specific T cells from COVID-19 patients. We will compare the T response to the quality of the systemic and mucosal humoral response. Finally, we will evaluate in parallel two new biomarkers of the severity of COVID-19: plasma calprotectin and the presence of antibodies to type 1 IFN antibodies.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Association of IFNAR1 and IFNAR2 with COVID-19 severity.
   Yaugel-Novoa M, Bourlet T, Longet S, Botelho-Nevers E, et al · · 2023 · cited 14× · PMID 37028439 · DOI 10.1016/s2666-5247(23)00095-2
2. Monitoring of Both Humoral and Cellular Immunities Could Early Predict COVID-19 Vaccine Efficacy Against the Different SARS-CoV2 Variants.
   Vogrig M, Berger AE, Bourlet T, Waeckel L, et al · · 2023 · cited 9× · PMID 36006568 · DOI 10.1007/s10875-022-01354-x
3. Prior COVID-19 Immunization Does Not Cause IgA- or IgG-Dependent Enhancement of SARS-CoV-2 Infection.
   Yaugel-Novoa M, Noailly B, Jospin F, Berger AE, et al · · 2023 · cited 5× · PMID 37112685 · DOI 10.3390/vaccines11040773
4. BA.1 breakthrough infection elicits distinct antibody and memory B cell responses in vaccinated-only versus hybrid immunity individuals.
   Saade C, Bruel T, Vrignaud LL, Killian M, et al · · 2025 · cited 3× · PMID 40224022 · DOI 10.1016/j.isci.2025.111962
5. Impaired mucosal IgA response in patients with severe COVID-19.
   Yaugel-Novoa M, Noailly B, Jospin F, Pizzorno A, et al · · 2024 · cited 2× · PMID 39358866 · DOI 10.1080/22221751.2024.2401940