Safety, Anti-inflammatory and antiviral effect of anti- Sars-CoV-2 Gamma globulin in severe COVID-19 patients
Keywords:
Clinical trial, pandemic, SARS-CoV-2 diagnosis, gamma globulin, anti-SARS-CoV-2, antiviral therapyAbstract
Introduction: Antiviral therapy is a treatment for COVID-19. During the pandemic, hyperimmune immunoglobulin was produced as a treatment for infected patients.
Objective: To evaluate the safety and explore the anti-inflammatory and antiviral effect of anti-Sars-CoV-2 gamma globulin in severely ill patients with COVID-19.
Materials and Methods: Exploratory, open-label, monocenter, controlled clinical trial. 2 groups of patients were randomized, with diagnosis confirmed by real-time polymerase chain reaction. A control group of 10 patients and a group of 11 patients who were administered hyperimmune immunoglobulin in a single dose (150 mg/kg). Both groups received treatment according to the national protocol for COVID-19 patients and were evaluated for 7 days.
Results: No causally related serious adverse events were reported; the probability of an attributable serious adverse event was 8%. In the intervention group, both mean neutrophil/lymphocyte ratio and C-reactive protein values decreased. The real-time polymerase chain reaction amplification cycle increased slightly, and D-dimer levels remained unchanged. Favorable outcomes were seen on X-ray in 10/11 patients, 95% CI (58.7; 98.7), and on CT in 5/11, 95% CI (16.7; 76.6). In the treated group, 72.7% of patients improved in severity parameters and 2/11 worsened, 95% CI (2.3; 51.8); none required mechanical ventilation. The median time in the Intensive Care Unit was 7.5 days, and the median hospitalization was 11 days.
Conclusions: Anti-SARS-CoV-2 gamma globulin showed evidence of safety and favorable outcome on day 7.
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