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

Not Applicable

Completed

• Conditions: COVID-19 Infection
• Interventions: Procedure: Convalescent Plasma

• Registration Number: NCT04408209
• Lead Sponsor: National and Kapodistrian University of Athens

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.

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.

Study Timeline

• Study Start: 2020-04-23
• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-05-29
• Primary Completion: 2023-08-30
• Study Completion: 2023-12-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Convalescent Plasma	Convalescent Plasma	Convalescent Plasma - early treatment of patients with severe COVID-19

Primary Outcome Measures

Name	Time	Method
Survival	Day 60	The primary endpoint of this trial is the survival on day 60.

Secondary Outcome Measures

Name	Time	Method
Clinical improvement ie percentage of patients not fulfilling the criteria for severe disease	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.

Trial Locations

Locations (6)

"Evangelismos" General Hospital; 🇬🇷 Athens, Attiki, Greece

"Agios Savas" Oncology Hospital; 🇬🇷 Athens, Attiki, Greece

"Alexandra" General Hospital; 🇬🇷 Athens, Attiki, Greece

"Sotiria" General Hospital; 🇬🇷 Athens, Attiki, Greece

Attikon" University General Hospital; 🇬🇷 Athens, Chaidari, Greece

University General Hospital of Patras; 🇬🇷 Patra, Rio, Greece