This is a randomized, placebo-controlled, double-blind phase I clinical study of anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS) to evaluate the safety and antiviral efficacy for the treatment of adult patients with mild COVID-19 and low risk of disease progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Placebo of saline solution of equal volume and infusion. Content of the infusion bag and tubing will be concealed with opaque covering.
INOSARS is a polyvalent passive immunization based on anti-SARS-CoV-2 immunoglobulin F(ab')2 fragments from hyperimmune equine serum. Inactive ingredients: water for injection, sodium chloride and less than 10% of total protein content.
Hospital San José, Tec de Monterrey
Monterrey, Nuevo León, Mexico
Average change from baseline in viral load as quantified by RT-qPCR from nasopharyngeal swab samples
Time frame: Baseline to days 2, 4, 7, 14 and 28
Proportion of patients with undetectable viral load as quantified by RT-qPCR from nasopharyngeal swab samples
Time frame: At days 2, 4, 7, 14 and 28
Time of viral activity
Number of days in which viral load remains detectable as quantified by RT-qPCR from nasopharyngeal swab samples
Time frame: Baseline to 28 days
Adverse events presented early after infusion
Number of adverse events per group presented in the first 24 hours
Time frame: Baseline to 24 hrs
Adverse events presented later after infusion
Number of adverse events per group presented 24 hours past infusion
Time frame: Day 2 until day 28
Incidence of anti-INOSARS antibodies
Time frame: Baseline and day 28
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