ABSTRACT
Background The therapeutic effectiveness of interleukin-6 (IL-6) receptor inhibitor in critically ill hospitalized patients with coronavirus disease 2019 (COVID-19) is uncertain. Methods To evaluate the efficacy and safety of the outcome as recovery or death of tocilizumab for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection, we conducted a randomized, double-blinded, placebo-controlled phase 2 trial in critically ill COVID-19 adult patients. The patients were randomly assigned in a 4:1 ratio to receive standard medical treatment plus the recommended dose of either tocilizumab or the placebo drug. Randomization was stratified. The primary outcome was the recovery or death after administration of tocilizumab or a placebo drug. The secondary outcomes were clinical recovery or worsening of the patients' symptoms and inflammatory markers and discharge from the hospital. Results Out of 190 patients included in this study, 152 received tocilizumab, and 38 received a placebo. The duration of hospital stay of the interventional group was 12.9±9.2, while the placebo group had a more extended hospital stay (15.6±8.8). The survival ratio in tocilizumab group was 0.82 (95% confidence interval [CI], 10.55 to 12.24;p=0.58 by log-rank test). The survival ratio in the placebo group was 0.23 (95% confidence interval [CI], 10.86 to 16.11;p=0.32 by log-rank test). The inflammatory markers in the tocilizumab group significantly declined by day 16 compared to the placebo group. Conclusions The use of tocilizumab was associated with decreased mortality, earlier improvement of inflammatory markers, and reduced hospital stay in patients with severe COVID-19.
ABSTRACT
BACKGROUND: Remdesivir is a monophosphoramidate prodrug of an adenosine analog, and it has a broad-spectrum antiviral activity against paramyxoviruses, flaviviruses, and coronaviruses. Remdesivir is associated with decreased hospital stay and improved outcomes in coronavirus- disease 2019 (COVID-19). METHODOLOGY: Of 846 suspected COVID-19 patients admitted to the hospital, 612 SARS-CoV-2 nasopharyngeal RT-PCR positive patients were evaluated for enrollment in this prospective cohort study. 159 RT-PCR positive patients were given remdesivir. Their clinical, biochemical parameters, hospital stay, and outcomes related to morbidity and mortality were followed. RESULTS: Out of the 159 patients, 141 recovered after remdesivir use. The Chi-square test for independence examined the relation between the day of the first dose, dose of remdesivir, and clinical outcome. The standardized case fatality ratio (CFR) in the 453 hospitalized patients who did not receive remdesivir was 32.89% (N = 149) as compared to 11.32% (N = 18) in the patients who received remdesivir. These findings are in keeping with the therapeutic value of remdesivir in symptomatic SARS-CoV-2 infection of varying severity. CONCLUSION: The use of remdesivir is associated with a decrease in the severity of the SARS-CoV-2 infection. Its use is also associated with a decreased length of hospital stay and lower mortality than the patients who did not receive remdesivir.