Status:
COMPLETED
Convalescent Plasma of Covid-19 to Treat SARS-COV-2 a Randomized Doble Blind 2 Center Trial
Lead Sponsor:
Grupo Mexicano para el Estudio de la Medicina Intensiva
Collaborating Sponsors:
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
National Institute of Pediatrics, Mexico
Conditions:
SARS Pneumonia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The new SARS-CoV-2 coronavirus is an emerging virus originating in Wuhan, China that has spread rapidly throughout the world. As of March 24, 2020, China had reported 81,767 cases with 3,281 deaths, a...
Detailed Description
Currently, SARS-CoV-2 disease represents a Public Health emergency of international concern. The new coronavirus COVID-19 is estimated to have infected more than 1.8 million people worldwide. The WHO ...
Eligibility Criteria
Inclusion
- Adults 18 to 70 years of age.
- Serious or critically ill patients confirmed for SARS-CoV-2 disease (RT-PCR).
- Meet the criteria for Disease with SARS-CoV-2 disease, phase II (Moderate) and phase III (severe) .
- Suspected Cytokine Release Syndrome with Hscore 169 points.
- Presence of severe acute hypoxemia with SpO2 \<90% in ambient air and / or PaO2 / FiO2 \<300 mmHg.
- Meet criteria (plain chest tomography or plain chest radiograph) for SARS-CoV-2 disease.
- Supplemental oxygen requirement either through the facial store plus reservoir bag, high-flow nasal tips or advanced airway management and invasive mechanical ventilation support.
Exclusion
- patient has no interest in participating in the trial.
- Bilateral pulmonary infiltrate related to heart failure or other cause of water overload.
- Virus positive respiratory viral panel other than COVID-19
- History of allergy to plasma, sodium citrate, or methylene blue.
- Patients with a history of autoimmune diseases or selective IgA insufficiency.
- Those patients who are participating in other protocols.
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04405310
Start Date
May 20 2020
End Date
December 10 2020
Last Update
December 21 2020
Active Locations (2)
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1
Hospital Nava de Alta Especialidad
Mexico City, Mexico, 04470
2
Hospital General de Mexico Dr Eduardo Liceaga
Mexico City, Mexico, 06720