COVID19-Convalescent Plasma for Treating Patients With Active Symptomatic COVID 19 Infection (FALP-COVID) (FALP-COVID)
COVID-19 Infection, Cancer Patients, General Population
About this trial
This is an interventional treatment trial for COVID-19 Infection focused on measuring convalescent plasma, COVID
Eligibility Criteria
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
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
- 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
Sites / Locations
- Fundacion Arturo Lopez PerezRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Cancer patients with COVID 19 infection and severity criteria
Cancer patients with COVID 19 infection and risk factors
Non-Cancer patients COVID 19 infection and severity criteria
Non-cancer patients COVID 19 (+) and risk factors
All patients will be treated with 1 or more convalescent plasma units
All patients will be treated with 1 or more convalescent plasma units
All patients will be treated with 1 or more convalescent plasma units
All patients will be treated with 1 or more convalescent plasma units