COVID-19 Clinical Trial
— PNASOfficial title:
Study of the Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies
Natural infection, vaccines and treatments (like monoclonal antibodies) lead to the appearance of a neutralizing power in the serum (due to induced or injected antibodies). This neutralizing power is recognized as a correlate of protection against a (new) infection. This study aims to measure the neutralizing power of the serum of patients (whether or not they have been infected with SARS-CoV-2) according to the treatments and/or vaccines received and to assess the durability of this power in the time.
| Status | Recruiting |
| Enrollment | 400 |
| Est. completion date | December 1, 2026 |
| Est. primary completion date | December 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Adult volunteers for the study, having received or about to receive any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies (vaccines - whatever the mode of action -, monoclonal antibodies). - Having given their consent to participate in the study Exclusion Criteria: - Minors - Pregnant women - Persons under tutorship or curatorship - Protected adults - Person under legal protection - Person not affiliated to a social security scheme - Persons unable to express their consent |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Régional d'Orléans, France | Orléans |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Régional d'Orléans |
France,
Grzelak L, Temmam S, Planchais C, Demeret C, Tondeur L, Huon C, Guivel-Benhassine F, Staropoli I, Chazal M, Dufloo J, Planas D, Buchrieser J, Rajah MM, Robinot R, Porrot F, Albert M, Chen KY, Crescenzo-Chaigne B, Donati F, Anna F, Souque P, Gransagne M, Bellalou J, Nowakowski M, Backovic M, Bouadma L, Le Fevre L, Le Hingrat Q, Descamps D, Pourbaix A, Laouenan C, Ghosn J, Yazdanpanah Y, Besombes C, Jolly N, Pellerin-Fernandes S, Cheny O, Ungeheuer MN, Mellon G, Morel P, Rolland S, Rey FA, Behillil S, Enouf V, Lemaitre A, Creach MA, Petres S, Escriou N, Charneau P, Fontanet A, Hoen B, Bruel T, Eloit M, Mouquet H, Schwartz O, van der Werf S. A comparison of four serological assays for detecting anti-SARS-CoV-2 antibodies in human serum samples from different populations. Sci Transl Med. 2020 Sep 2;12(559):eabc3103. doi: 10.1126/scitranslmed.abc3103. Epub 2020 Aug 17. — View Citation
Planas D, Bruel T, Grzelak L, Guivel-Benhassine F, Staropoli I, Porrot F, Planchais C, Buchrieser J, Rajah MM, Bishop E, Albert M, Donati F, Prot M, Behillil S, Enouf V, Maquart M, Smati-Lafarge M, Varon E, Schortgen F, Yahyaoui L, Gonzalez M, De Seze J, Pere H, Veyer D, Seve A, Simon-Loriere E, Fafi-Kremer S, Stefic K, Mouquet H, Hocqueloux L, van der Werf S, Prazuck T, Schwartz O. Sensitivity of infectious SARS-CoV-2 B.1.1.7 and B.1.351 variants to neutralizing antibodies. Nat Med. 2021 May;27(5):917-924. doi: 10.1038/s41591-021-01318-5. Epub 2021 Mar 26. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Day 0 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Day 0 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Day 3 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Day 3 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Day 15 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Day 15 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 1 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 1 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 2 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 2 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 3 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 3 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 4 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 4 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 5 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 5 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 6 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 6 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 9 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 9 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 12 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 12 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 18 | |
| Primary | Evolution of the serum humoral response | Evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 18 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Day 0 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Day 0 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Day 3 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Day 3 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Day 15 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Day 15 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 1 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 1 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 2 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 2 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 3 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 3 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 4 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 4 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 5 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 5 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 6 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 6 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 9 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 9 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 12 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 12 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Flow in BAU/ml (Binding Antibody Unit/milliliter) |
Month 18 | |
| Secondary | Evolution of the mucosal humoral response | Evolution of the mucosal humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies.
S-Fuse in ED50 (Effective Dilution 50% titers) |
Month 18 | |
| Secondary | Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Day 0 | |
| Secondary | Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Day 3 | |
| Secondary | Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Day 15 | |
| Secondary | Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 1 | |
| Secondary | Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 2 | |
| Secondary | Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 3 | |
| Secondary | Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 4 | |
| Secondary | Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 5 | |
| Secondary | Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 6 | |
| Secondary | Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 9 | |
| Secondary | Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 12 | |
| Secondary | Proportion of participants developing COVID-19 infection after these treatments | Proportion of participants developing COVID-19 infection after these treatments documented (by specific PCR) SARS-CoV-2 infection. | Month 18 |
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