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

NCT04408209 | Completed DMC

• 1 other identifier: 245-14-4-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (3)

• Survival

  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.

  Day 21

• Survival

  The primary endpoint of this trial is the survival on day 35.

  Day 35

• Survival

  The primary endpoint of this trial is the survival on day 60.

  Day 60

Secondary Outcomes (1)

• Clinical improvement ie percentage of patients not fulfilling the criteria for severe disease

  Day 21

Study Arms (1)

Convalescent Plasma

EXPERIMENTAL

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

Procedure: Convalescent Plasma

Interventions

Convalescent Plasma 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)

Convalescent Plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Confirmed SARS-CoV2 infection by PCR of the nasal/pharyngeal swab, sputum, BAL
• 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.

You may not qualify if:

• 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 0.5μg/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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Hellenic Society of Hematology: collaborator

Study Sites (6)

"Evangelismos" General Hospital

Athens, Attica, 10676, Greece

Location

"Agios Savas" Oncology Hospital

Athens, Attica, 115 22, Greece

Location

"Alexandra" General Hospital

Athens, Attica, 115 28, Greece

Location

"Sotiria" General Hospital

Athens, Attica, 11527, Greece

Location

Attikon" University General Hospital

Athens, Chaidari, 124 62, Greece

Location

University General Hospital of Patras

Pátrai, Rio, 26504, Greece

Location

Related Publications (1)

• Pappa V, Bouchla A, Terpos E, Thomopoulos TP, Rosati M, Stellas D, Antoniadou A, Mentis A, Papageorgiou SG, Politou M, Kotanidou A, Kalomenidis I, Poulakou G, Jahaj E, Korompoki E, Grigoropoulou S, Hu X, Bear J, Karaliota S, Burns R, Pagoni M, Trontzas I, Grouzi E, Labropoulou S, Stamoulis K, Bamias A, Tsiodras S, Felber BK, Pavlakis GN, Dimopoulos MA. A Phase II Study on the Use of Convalescent Plasma for the Treatment of Severe COVID-19- A Propensity Score-Matched Control Analysis. Microorganisms. 2021 Apr 11;9(4):806. doi: 10.3390/microorganisms9040806.

  PMID: 33920489 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Meletios Athanasios Dimopoulos

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

• Evangelos Terpos, MD

  National and Kapodistrian University of Athens

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: Single arm

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: May 29, 2020
• Study Start: April 23, 2020
• Primary Completion: August 30, 2023
• Study Completion: December 15, 2023
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (6)