Clinical trial NCT04408209: Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection
Official title: Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection - A Multicenter Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Infection
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: Hellenic Society of Hematology
First posted: 2020-05-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival
timeFrame: Day 21
measure: Survival
timeFrame: Day 35
measure: Survival
timeFrame: Day 60
Secondary outcomes:
measure: Clinical improvement ie percentage of patients not fulfilling the criteria for severe disease
timeFrame: Day 21
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "Evangelismos" General Hospital
state: Attiki
city: Athens
country: Greece
facility: "Agios Savas" Oncology Hospital
state: Attiki
city: Athens
country: Greece
facility: "Alexandra" General Hospital
state: Attiki
city: Athens
country: Greece
facility: "Sotiria" General Hospital
state: Attiki
city: Athens
country: Greece
facility: Attikon" University General Hospital
state: Chaidari
city: Patra
country: Greece
facility: University General Hospital of Patras
state: Rio
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Meletios Athanasios Dimopoulos
role: PRINCIPAL_INVESTIGATOR
affiliation: National and Kapodistrian University of Athens
name: Evangelos Terpos, MD
role: STUDY_CHAIR
References:
citation: 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.