In early December 2019, cases of pneumonia of unknown origin were identified in Wuhan, China. The causative virus was called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) has recently declared coronavirus disease 2019 (COVID-19) a public health emergency of international concern. According to the World Health Organization (WHO), the management of COVID-19 has focused primarily on infection prevention, detection and patient monitoring. However, there is no vaccine or specific treatment for SARS-CoV-2 due to the lack of evidence. Treatment options currently include broad-spectrum antiviral drugs but the efficacy and safety of these drugs is still unknown. Convalescent plasma has previously been used to treat various outbreaks of other respiratory infections; however, it has not been shown to be effective in all the diseases studied. Therefore, clinical trials are required to demonstrate its safety and efficacy in patients with VIDOC-19. The present work seeks to determine the mortality from any cause up to 14 days after plasma randomization of patients cured of COVID-19 compared to the Best Available Therapy in subjects with SARS-CoV-2 pneumonia. This is a 2:1 randomized, double-blind, single-center, phase 2, controlled clinical trial (plasma: best available therapy) for the treatment of SARS-CoV-2 pneumonia.
Randomized clinical trial comparing convalescent plasma to best available therapy (BAT) for
the treatment of severely ill and critically ill patient with COVID-19: Patients will be
electronically randomized 2:1 (plasma vs BAT) in a double blind fashion. Patients with
SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened
and invited to participate. Primary outcomes will be early all-cause mortality, and secondary
outcomes will include all cause in hospital mortality, length of mechanical ventilation and
hospital stay, time to PAO2 >200, progression of pulmonary infiltrates, antibody titers and
time to negative PCR detection
Biological: Plasma
The plasma unit will be fractionated in 200 mL aliquots for storage at -80°C until use. After thawing, it shall be administered in a single 200 mL dose to subjects who are randomized to that arm.
Other: Best Available Therapy
It shall include, but not be limited to, oxygen therapy by means of a nasal cannula; high-flow nasal cannula; invasive or non-invasive mechanical ventilation; intravenous hydration; antibiotic therapy; thrombus prophylaxis; pain and fever management.
Inclusion Criteria:
1. Men or women ≥18 years. If you are a woman of childbearing age, you must agree to
practice abstinence or to use an effective method of contraception during the study
period.
2. Vascular access suitable for administration of hemocomponents.
3. SARS-CoV-2 positive RT-PCR.
4. Negative pregnancy test in case of a woman of reproductive age
5. Signing of evidentiary document of informed consent.
6. Hospital admission for SARS-CoV-2 pneumonia with supplemental oxygen requirements.
7. Subjects who access the storage of biological samples for future examination.
Exclusion Criteria:
1. Respiratory rate >30 RPM, SO2 <93%, PaO2/FiO2 <200 despite intervention with oxygen
therapy after 60 minutes of hospitalization.
2. New alteration of the state of alert that does not revert after interventions 60
minutes after admission to hospital.
3. PAM ≤ 65mmHg despite initial resuscitation on arrival at the centre.
4. Pregnant or breastfeeding patients.
5. Patients that the investigators consider inappropriate to participate in the clinical
trial
6. Contraindication to transfusion or history of previous severe reaction to blood
products.
7. Have received any blood products in the last 120 days.
Hospital Universitario José E. Gonzalez
Monterrey, Nuevo Leon, Mexico
Adrian Camacho-Ortiz, MD, Principal Investigator
Hospital Universitario "Dr. Jose Eleuterio Gonzalez, UANL