The COVID-19 pandemic has been spreading continuously, and in Brazil, until August 18, 2020, there have been more than 3,359,000 cases with more than 108,536 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of using convalescent plasma for treating patients with COVID-19 pneumonia without indication of ventilatory support.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The intervention group will receive 400 mL of convalescent plasma with a SARS-CoV-2 antispike antibody titer with a dilution ≥ 1: 320.
D'Or Institute for Research and Education
Rio de Janeiro, Brazil
RECRUITINGArea under the curve of SARS-COV-2 viral load obtained from nasopharyngeal and /or oropharyngeal swabs.
To evaluate the area under the curve of SARSCoV-2 viral load in nasopharyngeal and or oropharyngeal samples on days 0, 3, 6, 9, 12, 15, 18 and 15 after randomization.
Time frame: 0, 3, 6, 9, 12, 15, 18 and 21 days
Assessment of clinical improvement using an Ordinal Severity Scale
The seven-point scale is as follows: * Death 7 points; * Hospital admission for mechanical ventilation plus additional organ support (eg, pressors, RRT, ECMO) = 6 points; * Hospital admission for mechanical ventilation = 5 points; * Hospital admission for non-invasive ventilation or high-flow oxygen therapy = 4 points; * Hospital admission for oxygen therapy (but not requiring high-flow or non-invasive ventilation) = 3 points; * Hospital admission but not requiring oxygen therapy = 2 points; * Discharged with limitations of activities = 1 point; * Discharged with no limitations of activities = 0 point;
Time frame: 0, 7, 10, 14, 21 and 28 days
Evaluate oxygen saturation
Time frame: 0, 3, 6, 9, 12, 15, 18 and 21 days
Evaluate oxygen supplementation
Time frame: 0, 3, 6, 9, 12, 15, 18 and 21 days
Assess respiratory rate
Time frame: 0, 3, 6, 9, 12, 15, 18 and 21 days
Evaluate the PaO2 / FiO2 ratio (for patients on mechanical mechanisms)
Time frame: 0, 3, 6, 9, 12, 15, 18 and 21 days
Length of hospital stay
Time frame: 21 days
Length of stay in intensive care
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 21 days
Assess the rate of orotracheal intubation
Time frame: 21 days
Change in the profile of cytokines/chemokines in both groups
Quantification by ELISA the levels of 36 molecules determined simultaneously using the Human Cytokine Array Kit da R\&D Systems (C5a, IL-4, IL-32 alpha, CD40 ligand, IL-5, CXCL10 / IP-10, G-CSF, IL-6, CXCL11 / I-TAC, GM-CSF, IL-8, CCL2 / MCP-1, CXCL1 / GRO alpha, IL-10, MIF, CCL1 / I-309, IL-12 p70, CCL3 / MIP-1 alpha, ICAM-1, IL-13, CCL4 / MIP-1 beta, IFN -gamma, IL-16, CCL5 / RANTES, IL-1 alpha, IL-17, CXCL12 / SDF-1, IL-1 beta, IL-17E, Serpin E1 / PAI-1, IL-1ra, IL-23, TNF-alpha, IL-2, IL-27 and TREM-1)
Time frame: 0, 3, 6, 9, 12, 15, 18 and 21 days
Presence of antibodies against SARS-CoV-2 in serum after convalescent plasma administration
Time frame: 0, 3, 6, 9, 12, 15, 18 and 21 days
Death rate
Time frame: 7, 10, 14, 21 and 28 days
Rate of transfusion reactions to convalescent plasma infusion
Time frame: 21 days