COVID-19 Pneumonia Clinical Trial
— PROMETEOOfficial title:
Pilot Clinical, Statistical and Epidemiological Study on Efficacy and Safety of Convalescent Plasma for the Management of Patients With COVID-19
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.
Status | Not yet recruiting |
Enrollment | 15 |
Est. completion date | April 1, 2021 |
Est. primary completion date | March 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Universitario "Dr. Gonzalo Valdés Valdés" | Saltillo | Coahuila |
Lead Sponsor | Collaborator |
---|---|
Universidad Autonoma de Coahuila | National Council of Science and Technology, Mexico |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause mortality | Any cause mortality during the first 30 days of treatment | 30 days | |
Primary | Side effects | Side effects associated with the administration of convalescent plasma | 30 days | |
Secondary | Length of stay in Intensive Care Unit (ICU) | Time to discharge from the ICU | 14 days | |
Secondary | Length of stay in hospitalization | Time for discharge from hospital | 21 days | |
Secondary | Days of mechanical ventilation | Number of days with ventilatory support | 14 days | |
Secondary | Inflammatory biomarkers (d-dimer) | change in D-dimer (micrograms/L) | 21 days | |
Secondary | Inflammatory biomarkers (c-reactive protein) | change in C-reactive protein (milligrams/dL) | 21 days | |
Secondary | Inflammatory biomarkers (lactate dehydrogenase) | Change in LDH (UI/L) | 21 days | |
Secondary | Inflammatory biomarkers (ferritin) | Change in ferritin (nanograms/mL) | 21 days |
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