Convalescent Plasma, COVID-19 Pneumonia
Conditions
Keywords
COVID-19, Convalescent plasma, plasmapheresis
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALConvalescent 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.
Sponsors
National Council of Science and Technology, Mexico
Universidad Autonoma de Coahuila
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Pilot, experimental, randomized, prospective, longitudinal, clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 30 days | Any cause mortality during the first 30 days of treatment |
| Side effects | 30 days | Side effects associated with the administration of convalescent plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory biomarkers (c-reactive protein) | 21 days | change in C-reactive protein (milligrams/dL) |
| Inflammatory biomarkers (lactate dehydrogenase) | 21 days | Change in LDH (UI/L) |
| Days of mechanical ventilation | 14 days | Number of days with ventilatory support |
| Length of stay in Intensive Care Unit (ICU) | 14 days | Time to discharge from the ICU |
| Length of stay in hospitalization | 21 days | Time for discharge from hospital |
| Inflammatory biomarkers (ferritin) | 21 days | Change in ferritin (nanograms/mL) |
| Inflammatory biomarkers (d-dimer) | 21 days | change in D-dimer (micrograms/L) |
Countries
Mexico
Contacts
Primary ContactJulio César Martínez Gallegos, MD, MMSc
Outcome results
None listed