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Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection

NCT04408209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-11-18

No results posted yet for this study

Summary

This is a multicenter, Phase 2 study, to assess the efficacy of the treatment with convalescent plasma in patients with severe COVID-19 infection.

Conditions

  • COVID-19 Infection

Interventions

PROCEDURE

Convalescent Plasma

Convalescent Plasma - early treatment of patients with severe COVID-19. Clinical and laboratory data of patients will be collected before initiation of the procedure, 30 minutes after the first dose, 30 minutes after the second dose and 30 minutes after the third plasma dose and then on days 1-7, 14, 21, 28, 35 from the start of treatment. In case of adverse reactions during transfusion such as acute shortness of breath, haemodynamic instability or high pre-existing and non-disease-related fever, the transfusion will be interrupted and detailed recording of the event as well as updating the Adverse Events Management Committee will be performed. In addition to the standard assessments, the titer of neutralizing anti-SARS-CoV-2 antibodies will be measured in a sample drawn prior to plasmapheresis. All donors will be tested for: 1. the titer of IgG anti-SARS-CoV-2 antibodies (Pasteur Institute) 2. the titer of neutralizing anti-SARS-CoV-2 antibodies (Pasteur Institute)

Sponsors & Collaborators

  • Hellenic Society of Hematology

    collaborator OTHER

  • National and Kapodistrian University of Athens

    lead OTHER

Principal Investigators

  • Meletios Athanasios Dimopoulos · National and Kapodistrian University of Athens

  • Evangelos Terpos, MD · National and Kapodistrian University of Athens

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-23
Primary Completion
2023-08-30
Completion
2023-12-15

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04408209 on ClinicalTrials.gov