Covid-19 Convalescent Plasma and Monoclonal Antibodies Treatment of Immunocompromised Patients

COVID-19 Convalescent Plasma Treatment Clinical Trial

— Covid-IC  

Official title:

Analysis of the Efficacy and Tolerance of Covid-19 Convalescent Plasma and Monoclonal Antibodies in the Treatment of SARS-Cov2 Infections in Immunocompromised Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05905380
• Other study ID #: 8784
• Status: Recruiting
• Start date: March 2, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: June 2023
• Source: University Hospital, Strasbourg, France
• Contact: François DANION, MD
• Phone: 33 3 69 55 15 88
• Email: Francois.danion[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Data on the use of convalescent plasma in the treatment of covid-19 are scarce: the results of randomized studies involving mainly immunocompetent patients are disappointing, while case series or retrospective data on more selected patients , in particular immunocompromised patients suggest a benefit in these patients whose clinical manifestation seems essentially related to the uncontrolled infection and not the cytokine storm.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Adult patient

• Immunocompromised patient (solid neoplasia, malignant hemopathy, solid organ transplantation, primary immune deficiency, systemic disease, chronic inflammatory disease, etc.)

• Hospitalized between 25/02/2020 and 15/01/2023 at HUS, ICANS, CH Colmar and CH Mulhouse

• Having received curative monoclonal antibody treatment or convalescent plasma treatment for SARS-Cov2 infection

• Patient who has not expressed, after being informed, his opposition to the reuse of his data for scientific research purposes.

Exclusion criteria:

• Subject who expressed their opposition to participating in the study

• Subject under guardianship, curatorship or safeguard of justice

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Convalescent Plasma Treatment

Locations

Country	Name	City	State
France	Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective analysis of the tolerance of Covid-19 convalescent plasma and monoclonal antibodies in the treatment of SARS-Cov2 infections in immunocompromised patients	This is a retrospective study on patient data from medical records from February 25, 2020 to January 15, 2023	Files analysed retrospectively from February 25, 2020 to January 15, 2023 will be examined