A Phase I/II clinical trial for safety and efficacy evaluation of treatment with anti-SARS-CoV-2 equine immunoglobulin (F(ab')2) in hospitalized patients with COVID-19 not requiring of invasive ventilation support.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Treatment with Anti-SARS-CoV-2 immunoglobulin
Rate of adverse events related to the infusion of anti-SARS-CoV-2 immunoglobulin through CTCAE v4.0.
Time frame: 28 days
Clearence of viral RNA evaluated by RT-PCR
Time frame: 72 h
Reduction of viral load evaluated by area under the curve of RT-PCR values
Viral load reduction evaluated by area under the curve of RT-PCR values
Time frame: Day 0, Day 3, Day 7 and Day 14
Length of hospital stay
number of days between admission and discharge
Time frame: For as long as the duration of the hospital stay
Orotracheal Intubation Rate
Number of patients who progressed to the use of invasive mechanical ventilation and require orotracheal intubation throughout hospitalization
Time frame: 28 days
Infusional reaction rate
number of patients who experienced adverse events after the immunoglobulin infusion
Time frame: 28 days
Mortality rate
number of deceased patients
Time frame: 28 days
Assessment of adverse events
Frequency of adverse events classified following CTCAE
Time frame: 28 days
Evaluation of clinical status
Results of a 7-point ordinal severity scale
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Time frame: Day 0, Day 14, Day 21 and Day 28
Modulation of serum and cellular inflammatory marker
Exploratory analysis of the variation of inflammatory markers by ELISA/Luminex and flow cytometry, compared to baseline levels
Time frame: Day 0, Day 3 and Day 7.