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

STATUS

Recruiting
participants needed

60
sponsor

National and Kapodistrian University of Athens

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Updated on 19 February 2024

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ct scan

shock

organ failure

pao2

FIO2

x-rays

oximetry

covid-19

chest x-ray

SARS

chest ct

respiratory failure

fraction of inspired oxygen (fio2)

acute respiratory syndrome (sars)

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.

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.

Details

Condition	COVID-19 Infection
Age	18years - 100years
Treatment	Convalescent plasma
Clinical Study Identifier	NCT04408209
Sponsor	National and Kapodistrian University of Athens
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age >18 years
	Confirmed SARS-CoV2 infection by PCR of the nasal/pharyngeal swab, sputum, BAL
	Onset of the disease symptoms no more than 12 days before the inclusion of the patients in the trial
	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
	Life threatening infection as determined by one of the following
	Respiratory failure
	Septic Shock
	Multiple organ failure
	Signature of informed consent by the patient or legal representative Patients fulfilling criteria 1, 2, 3, 6 and one of criteria 4 or 5 will be eligible for the study
Exclusion Criteria
	Critical illness due to progressive COVID-19 with expected survival time <48 hours
	Intubated patients >72 hours
	Chronic Heart failure NYHA 3 and/or preexisting left ventricular ejection fraction 30%
	Cardiovascular failure requiring 0.5g/Kg/min nor-adrenaline or equivalent or more than 2 types of vasopressor medication
	Liver Cirrhosis Child C
	Liver failure with bilirubin >5X ULN and increase of ALT/AST (at least one >10X ULN)
	Previous history of allergic reaction to blood or blood products transfusion
	Known IgA deficiency
	Pregnancy
	Breast feeding women
	Pulmonary edema

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