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NCT Number: NCT04408209

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

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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Key information

Conditions

COVID-19 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"Agios Savas" Oncology Hospital, Athens, Attica, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 0.5μg/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

Treatment and study plan

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:

  • the titer of IgG anti-SARS-CoV-2 antibodies (Pasteur Institute)
  • the titer of neutralizing anti-SARS-CoV-2 antibodies (Pasteur Institute)

Primary outcomes

  1. 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.

  2. Survival

    Time frame: Day 35

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

  3. Survival

    Time frame: Day 60

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • Hellenic Society of Hematology

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 29, 2020
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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