The trial was a cooperation between Pfizer and the ARO at the Hospital Israelita Albert Einstein in Sao Paulo, Brazil, which served as the trial's coordinating centre. Tofacitinib has not been approved or permitted for use in the treatment of COVID-19 by any regulatory authority globally, and it should not be administered in patients with a current severe infection.

Tofacitinib had a lower cumulative incidence of mortality or respiratory failure through day 28 (the primary outcome of the study) than placebo (29.0 percent) (risk ratio 0.63; 95 percent confidence interval [CI], 0.41 to 0.97; p=0.04) in the experiment. Through day 28, death from any cause occurred in 2.8 percent of tofacitinib participants and 5.5 percent of placebo patients (hazard ratio 0.4).

Serious adverse events occurred in 20 patients (14.1%) in the tofacitinib group and 17 (12.0%) in the placebo group. Among protocol-specified adverse events of special interest, deep vein thrombosis, acute myocardial infarction, ventricular tachycardia, and myocarditis occurred in one patient each in the tofacitinib group; hemorrhagic stroke and cardiogenic shock occurred in one patient each in the placebo group. The incidence of serious infection was 3.5% in the tofacitinib group and 4.2% in the placebo group.

“To effectively combat the COVID-19 pandemic, there remains a critical need for multiple therapeutic options to treat patients who have contracted the virus,” said Tamas Koncz, M.D., Ph.D., Chief Medical Officer, Pfizer Inflammation & Immunology. “As outlined in Pfizer’s five-point plan at the onset of the COVID-19 pandemic, we are keenly focused on working across the healthcare ecosystem with partners like Hospital Israelita Albert Einstein. We look forward to our continued collaboration as we analyze the full dataset from this study and assess next steps.”

The multi-center, randomized, double-blind, placebo-controlled trial included adult patients hospitalized with COVID-19 pneumonia receiving standard of care. Patients were randomized in a 1:1 ratio to receive either tofacitinib 10 mg twice daily plus standard of care or placebo twice daily plus standard of care for up to 14 days or until hospital discharge. Overall, 89.3% used glucocorticoids during hospitalization, predominantly dexamethasone.

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