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Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection | Clinical Trials | Clareo Health

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

Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection - A Multicenter Phase II Trial

NCT04408209•National and Kapodistrian University of Athens

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.

Detailed Description

Convalescent plasma will be collected by plasmapheresis from patients fully recovered from COVID-19 infection and will be administered in patients with severe COVID-19 infection. The results will be compared with an historical matched control.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age \>18 years
•2. Confirmed SARS-CoV2 infection by PCR of the nasal/pharyngeal swab, sputum, BAL
•3. Onset of the disease symptoms no more than 12 days before the inclusion of the patients in the trial
•4. Severe COVID-19 infection as determined with one of the following:
•* Respiratory rate 30/min
•* Oxygen Hemoglobin Saturation SAT 93
•* CRP \>1.5 (upper normal limit \<0.5)
•* Ferritin value \>100
•* Ratio of PaO2:FiO2 \<300mmHg
•* Pulmonary infiltrates in Chest X-Ray or Chest CT scan \>50% during 24-48 hours
+5 more criteria

Exclusion Criteria

•1. Critical illness due to progressive COVID-19 with expected survival time \<48 hours
•2. Intubated patients \>72 hours
•3. Chronic Heart failure NYHA 3 and/or preexisting left ventricular ejection fraction 30%
•4. Cardiovascular failure requiring 0.5μg/Kg/min nor-adrenaline or equivalent or more than 2 types of vasopressor medication
•5. Liver Cirrhosis Child C
•6. Liver failure with bilirubin \>5X ULN and increase of ALT/AST (at least one \>10X ULN)
•7. Previous history of allergic reaction to blood or blood products transfusion
•8. Known IgA deficiency
•9. Pregnancy
•10. Breast feeding women
+1 more criteria

Locations (6)

"Evangelismos" General Hospital

Athens, Attica, Greece

"Agios Savas" Oncology Hospital

Athens, Attica, Greece

"Alexandra" General Hospital

Athens, Attica, Greece

"Sotiria" General Hospital

Athens, Attica, Greece

Attikon" University General Hospital

Athens, Chaidari, Greece

University General Hospital of Patras

Pátrai, Rio, Greece

Key Dates

Start Date

April 23, 2020

Primary Completion Date

August 30, 2023

Completion Date

December 15, 2023

Last Updated

November 18, 2024

Enrollment

ACTUAL participants

Conditions

COVID-19 Infection

Interventions

Convalescent Plasma

PROCEDURE

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RECRUITINGPHASE2

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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