COVID-19 infection has spread worldwide causing several deaths in few months Convalescent Plasma from COVID 19 donors has shown huge activity in small series from Chinese patients and currently many centers from USA and the European Union are assessing its use looking to avoid mortality and prolonged hospitalizations COVID-19-related
This is a collaborative, 4 arms , non randomized clinical trial assessing the use of
Convalescent Plasma from COVID-19 recovered donors to be used in oncological and
non-oncological patients with current severe COVID-19 infection or in patients with risk
factors of major complications secondary to COVID-19 infection
Biological: Convalescent Plasma from COVID-19 donors
Patients that will participate in this clinical trial will be treated with Convalescent Plasma from COVID-19 donors regardless of the arm where they will be included
Inclusion Criteria:
For all patients:
A. Patient must sign an informed consent to participate in this trial
B. Signed consent to participate in this trial must be given not after 14 days from the
first day of symptoms COVID-19 related
1. Patients with severity criteria must have any of the following: dyspnea and or
respiratory rate >=30 per min and or saturation <= 93% with fraction of inspired
oxygen 21% and or ratio of partial pressure arterial oxygen and fraction of inspired
oxygen (PaFi )<300 and or lung images showing worsening in 24-48 hours
or
2. Patients without severity criteria but with 2 or more factor risks:
A. 50 years or older
B. any of the following comorbidities: Diabetes Mellitus, Hypertension, Chronic Obstructive
Pulmonary Disease, Chronic Kidney Failure, non-oncological related chronic
immunosuppression
C. Total bilirubin>1,2 mg/dl or Blood Urea Nitrogen> 20 mg/dl or Lactate Dehydrogenase>245
U/L
D. D-dimer > 1mg/L
E. Neutrophils 7.3 x 10³ or greater and or Lymphocytes lesser than 0,8 x 10³ µl
F. C reactive protein >9,5 mg/dl and ferritin > 300 ug/ml
G. Interleukin-6 >7 pg/mL
H. antineoplastic treatment such as radiotherapy- cytotoxic chemotherapy- immunotherapy-
molecular therapy- oncological surgery during the last 8 weeks
Exclusion Criteria:
- known allergy to plasma
- Severe multiple organic failure
- Active intra brain hemorrhage
- Disseminated intravascular coagulation with blood products requirements
- Patient with an adult respiratory distress longer than 10 days
- patients with active cancer and life expectancy shorter than 12 months according with
medical criteria
Fundacion Arturo Lopez Perez
Providencia, Santiago, Chile
Investigator: Christian Caglevic, md
christian.caglevic@falp.org
Christian Caglevic, MD
56981369487
christian.caglevic@falp.org
Raimundo Gazitua, MD, Principal Investigator
Fundacion Arturo Lopez Perez