Pre-exposure Prophylaxis of SARS-CoV-2 Infection (COVID-19) by Monoclonal Antibodies With Early Access Authorization in Immunocompromised Patients. A Prospective Cohort.
ClinicalTrials.gov; 25/01/2022; TrialID: NCT05216588
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05216588
ABSTRACT
Condition
COVID-19;Immunocompromised HostPrimary outcome:
Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activityCriteria
Inclusion Criteria
- Adults (18 years-old or more)
- Patient who received the first administration of Evusheld at 300 mg for less than 4
months and should receive a second dose, according to French recommendations OR
Patient scheduled to receive or having received less than a month ago an injection of
anti-SARS-CoV-2 monoclonal antibodies, as pre-exposure prophylaxis at 600 mg,
according to the French SARS-CoV-2 RT recommendations
- qPCR negative at baseline
- SARS-CoV-2 RT-qPCR Negative at inclusion
- Patients who remain seronegative after a complete COVID-19 vaccination schedule
- Immunocompromised patients
Hemopathy chronic lymphoid leukemia, non hodgkin's lymphoma, HSCT Transplant recipient
kidney, liver, lungs Patients receiving anti CD20 or others immunosuppressor
- Life expectancy > 3 months
- Social security affiliation
- Lack of a legal protection measure
- Signed informed consent
Exclusion Criteria
- Participation to another clinical study
- State medical aid
- Ongoing or scheduled plasmapheresis or immunoadsorption
- Pregnant / lactating woman
- Patient whose isolation period is underway following contact with a confirmed case of
SARS-CoV2 infection
- Hypersensitivity to one of the active substances or to one of the excipients
Collection:
Clinical trial registers
Database:
ICTRP
Topics:
Vaccines
Year:
2022
Document Type:
Clinical Trial Register
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