Convalescent Plasma of Covid-19 to Treat SARS-COV-2 a Randomized Doble Blind 2 Center Trial (CPC-SARS)
SARS Pneumonia
About this trial
This is an interventional treatment trial for SARS Pneumonia focused on measuring SARS-COV-2, CONVALESCENT PLASMA
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Hospital Nava de Alta Especialidad
- Hospital General de Mexico Dr Eduardo Liceaga
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
EXP-PC-F2
EXP-NONPC-F2
EXP-PC-F3
EXP-NONPC-F3
Patients with Pneumonia due to SARS-COV-2 phase 2 with Hyperimmune Plasma from Convalescent patients and conventional Therapy (Azithromycin and Hydroxychloroquine)
20 Patients with Pneumonia due to SARS-COV-2 phase 2 with conventional Therapy (Azithromycin and Hydroxychloroquine) and 20% Albumin in Hartman Solution.
20 Patients with Pneumonia due to SARS-VOC-2 phase 3 with Hyperimmune Plasma from Convalescent patients and conventional Therapy (Azithromycin and Hydroxychloroquine)
20 Patients with Pneumonia due to SARS-VOC-2 phase 3 with conventional Therapy (Azithromycin and Hydroxychloroquine) and 20% Albumin in Hartman Solution.