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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-23

Study Completion Date

2023-12-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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COVID-19 Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Convalescent Plasma

Convalescent Plasma - early treatment of patients with severe COVID-19

Group Type EXPERIMENTAL

Convalescent Plasma

Intervention Type PROCEDURE

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)

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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. Life threatening infection as determined by one of the following:

* Respiratory failure
* Septic Shock
* Multiple organ failure
6. 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

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
11. Pulmonary edema

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Professor Meletios-Athanasios Dimopoulos

Professor & Rector of the NKU Athens Plasma Cell Dyscrasias Unit Section of Hematology & Medical Oncology Department of Clinical Therapeutics School of Medicine NKU Athens Alexandra Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR