The health contingency established against the Severe Acute Respiratory Syndrome associated type 2 Coronavirus (SARS-CoV-2) has promoted a race against the clock for the search on treatment against the disease related with coronavirus (COVID-19). There are no current approved therapeutic options against the virus, although there is a rush for the development of drugs, vaccines and even the passive immunization through plasma from convalescent patients. This passive immunization is made with the administration of antibodies from patients that went through the infectious state of the disease and progress to clinical remission. SARS-CoV-2, and its predecessor SARS-CoV-1, have great similarities between their genes and proteins; tis allow to hypothesize that the antibodies developed against SARS-CoV1 can recognize the antigens of SARS-CoV-2. In this manner, the transfusion of convalescent plasma to patients with the infection brings the probability on eliminating the infection, in this case SARS-CoV-2. There are evidence of this phenomenon observed in previous pandemics caused by SARS-CoV-1, Influenza AH1N1 and Ebola virus. The objective of the study is to develop a therapeutic strategy based on the administration of plasma from patients with COVID-19 with clinical remission to patients that are coursing with the infection. The expected results hopes to establish an effective treatment and satisfactory recovery of patients with COVID-19. Also, we expect to describe the respective antibodies related against the SARS-CoV-2 infection.
The health contingency established against the Severe Acute Respiratory Syndrome associated
type 2 Coronavirus (SARS-CoV-2) has promoted a race against the clock for the search on
treatment against the disease related with coronavirus (COVID-19). There are no current
approved therapeutic options against the virus, although there is a rush for the development
of drugs, vaccines and even the passive immunization through plasma from convalescent
patients. This passive immunization is made with the administration of antibodies from
patients that went through the infectious state of the disease and progress to clinical
remission.
SARS-CoV-2, and its predecessor SARS-CoV-1, have great similarities between their genes and
proteins; tis allow to hypothesize that the antibodies developed against SARS-CoV1 can
recognize the antigens of SARS-CoV-2. In this manner, the transfusion of convalescent plasma
to patients with the infection brings the probability on eliminating the infection, in this
case SARS-CoV-2. There are evidence of this phenomenon observed in previous pandemics caused
by SARS-CoV-1, Influenza AH1N1 and Ebola virus.
The objective of the study is to develop a therapeutic strategy based on the administration
of plasma from patients with COVID-19 with clinical remission to patients that are coursing
with the infection. The expected results hopes to establish an effective treatment and
satisfactory recovery of patients with COVID-19. Also, we expect to describe the respective
antibodies related against the SARS-CoV-2 infection.
Biological: Convalescent plasma
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.
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)
Hospital Universitario "Dr. Gonzalo Valdés Valdés"
Saltillo, Coahuila, Mexico
Investigator: Julio César Martínez Gallegos, MD, MSc
Contact: 8113852249
juliomartinez.18@hotmail.com
Julio César Martínez Gallegos, MD, MMSc
8113852249
juliomartinez.18@hotmail.com