Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection
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|ClinicalTrials.gov Identifier: NCT04408209|
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Infection||Procedure: Convalescent Plasma||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm|
|Masking:||None (Open Label)|
|Official Title:||Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection - A Multicenter Phase II Trial|
|Actual Study Start Date :||April 23, 2020|
|Estimated Primary Completion Date :||August 30, 2021|
|Estimated Study Completion Date :||September 15, 2021|
Experimental: Convalescent Plasma
Convalescent Plasma - early treatment of patients with severe COVID-19
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:
- Survival [ Time Frame: Day 21 ]The primary endpoint of this trial is the survival on day 21. The primary endpoint, as a dichotomous composite of survival (yes/no) and no longer fulfilling criteria of severe COVID-19, will be analyzed according their classification. Specifically, categorical variables will be analyzed by means of absolute and relative frequencies, and all continuous variables will be described using arithmetic mean, standard deviation, median, quartiles. Also, geometric means, variance and 95% confidence intervals (CI), will be calculated for all pharmacokinetics parameters.
- Survival [ Time Frame: Day 35 ]The primary endpoint of this trial is the survival on day 35.
- Survival [ Time Frame: Day 60 ]The primary endpoint of this trial is the survival on day 60.
- Clinical improvement ie percentage of patients not fulfilling the criteria for severe disease [ Time Frame: Day 21 ]The secondary endpoint of this trial is that no longer fulfilling criteria of severe COVID-19 within 21 days after inclusion. This will be assessed on the basis of respiratory rate and ventilation support.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408209
|Contact: Aikaterini Niarchou||+30 firstname.lastname@example.org|
|Contact: Ioanna Charitaki||+30 email@example.com|
|"Evangelismos" General Hospital||Recruiting|
|Athens, Attiki, Greece, 10676|
|"Agios Savas" Oncology Hospital||Recruiting|
|Athens, Attiki, Greece, 115 22|
|"Alexandra" General Hospital||Recruiting|
|Athens, Attiki, Greece, 115 28|
|"Sotiria" General Hospital||Recruiting|
|Athens, Attiki, Greece, 11527|
|Attikon" University General Hospital||Recruiting|
|Athens, Chaidari, Greece, 124 62|
|University General Hospital of Patras||Recruiting|
|Patra, Rio, Greece, 26504|
|Principal Investigator:||Meletios Athanasios Dimopoulos||National and Kapodistrian University of Athens|
|Study Chair:||Evangelos Terpos, MD||National and Kapodistrian University of Athens|