Statistical and Epidemiological Study Based on the Use of Convalescent Plasma for the Management of Patients With COVID-19 (PROMETEO)
COVID-19 Pneumonia, Convalescent Plasma
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring COVID-19, Convalescent plasma, plasmapheresis
Eligibility Criteria
Inclusion Criteria (Donors):
- Signed informed consent
- At least positive for 1 q-PCR test for SARS-CoV-2
- 14 days of COVID-19 clinical remission
- Positive serologic test for SARS-CoV-2
- Requirements to donate according to NOM-253-SSA1-2012
- To accept sample storing for future study
Inclusion Criteria (Receptors):
- Signed informed consent provided by the patient, legal guardian or the health provider if not available
- Patients hospitalized in an ICU dedicated to the treatment of COVID-19 patients
- At least positive for 1 q-PCR test for SARS-CoV-2
- Patients with COVID-19 defined as severe or critically ill:
Severe: RF > 30 bpm, oxygen saturation <94%, Pa/FiO2 <301, bilateral lung infiltrates that extends in >50% (by chest radiograph or CT scan) in 24-48 hours Critically ill: Respiratory failure (PaO2 <60 mmHg or SatO2 <90% with FiO2 >60%) and septic shock (MAP <65 mmHg with vasoactive requirement, lactate > 2 mmol/L and SOFA score >1)
Exclusion Criteria:
- Positive pregnancy test
- Patients in lactation
- Informed consent not signed
- Patients involved in other treatment protocols
- Patients on immunomodulatory drugs (DMARDs, monoclonal antibodies or smal molecule drugs)
Sites / Locations
- Hospital Universitario "Dr. Gonzalo Valdés Valdés"
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Convalescent plasma
Best available treatment
Best available treatment + convalescent plasma Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician. Plasma will be split by aliquots of 200 ml for its storage on -60 celsius degrees until it's used. After defrosting, it will be administered on 2 200 ml separated doses on a 12 hours interval.
Best available treatment + Placebo (0.9% saline solution) Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician. Placebo will consist on 2 doses of 200 ml of 0.9% saline solution separated on a 12 hour interval.