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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 Host

Primary 

outcome:

Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity;Neutralizing antibody activity

Criteria


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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Collection: Clinical trial registers Database: ICTRP Topics: Vaccines Year: 2022 Document Type: Clinical Trial Register