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Temporal kinetics of antibody and cellular response markers and relative impact of revaccination in patients recovered from COVID-19 after treatment with monoclonal antibodies

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514071-17-00
Acronym
Renoir
Enrollment
150
Registered
2024-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19 infection

Brief summary

Evaluation of the effectiveness of revaccination at 4 versus 12 months on the temporal kinetics of humoral and cellular response markers.

Detailed description

1) Evaluate the anti-N IgG antibody titer at 0, 1, 4, 6, 9, 12 months after the MAbs infusion 2) Evaluate the anti-S IgG antibody titer at 0, 1, 4, 6, 9, 12 months after the MAbs infusion 3) Evaluate the titer of neutralizing antibodies at 0, 1, 4, 6, 9, 12 months after the MAbs infusion 4) Evaluate cellular immunity to S and N with IGRA test at 0, 4, 12 months after MAbs infusion

Interventions

DRUGComirnaty 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
DRUGSpikevax 0.2 mg/mL dispersion for injection COVID-19 mRNA Vaccine
DRUGEVUSHELD 150 mg + 150 mg solution for injection
DRUGXevudy 500 mg concentrate for solution for infusion
DRUGNuvaxovid dispersion for injection COVID-19 Vaccine (recombinant
DRUGadjuvanted)

Sponsors

National Institute For Infectious Diseases Lazzaro Spallanzani
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Evaluation of the effectiveness of revaccination at 4 versus 12 months on the temporal kinetics of humoral and cellular response markers.—

Secondary

MeasureTime frame
1) Evaluate the anti-N IgG antibody titer at 0, 1, 4, 6, 9, 12 months after the MAbs infusion 2) Evaluate the anti-S IgG antibody titer at 0, 1, 4, 6, 9, 12 months after the MAbs infusion 3) Evaluate the titer of neutralizing antibodies at 0, 1, 4, 6, 9, 12 months after the MAbs infusion 4) Evaluate cellular immunity to S and N with IGRA test at 0, 4, 12 months after MAbs infusion—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026