A Pilot and Feasibility Study to Evaluate the Effectiveness of Tofacitinib Add-On Therapy to Remdesivir in Severely Ill COVID-19 Patients.

Abstract

Aim: This placebo-controlled and randomized pilot study aimed to assess the feasibility and impact of tofacitinib/remdesivir combination therapy compared to remdesivir alone on clinical and laboratory findings of severely ill COVID-19 patients for future large-scale studies.

Method: Fifty patients were included in this study. They were randomly allocated into two groups of 25 subjects each. Patients in the treatment group received a five-day course of tofacitinib (10 mg twice daily) in addition to a five-day course of remdesivir, whereas the control group received a 10-day course of remdesivir with a placebo.

Results: There was no significant difference in rates of need for intubation (oxygen saturation level), intensive care unit (ICU) admission, death and length of hospitalization between the two groups (P>0.05). Nevertheless, the PRIEST severity score was significantly reduced in the treatment group compared to the control group (P=0.03, effect size [95% CI]: -0.616 [0.0233-1.1723]). Moreover, the mean level of C-reactive protein after 10 days was significantly decreased in the treatment group but increased in the control group (P=0.006).

Conclusion: Tofacitinib adopted in this pilot study modulate the inflammation and reduce the PRIEST score in severe COVID-19 patients. So, it is feasible and could be applied in future larger-scale trials to precisely determine its effects on coronavirus infections.