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Novartis Conducted Clinical Trials in India for Covid Drug Ruxolitinib

Novartis Conducted Clinical Trials in India for Covid Drug Ruxolitinib

Swiss major Novartis sought regulatory approval in India to initiate Phase III clinical trials for its drug, Ruxolitinib used in the treatment of Covid 19.

These trials were part of a global study that the company started in May to evaluate the use of Ruxolitinib (sold as Jakavi) for treatment of a severe immune overreaction or cytokine storm, that can lead to life-threatening respiratory complications in patients with Covid-19.

The trials were conducted on moderately-ill Covid-19 patients who required hospitalization but not ICU admission. 5 mg of the drug was administered twice a day for 14 days. If there was no improvement, the regimen was continued for another fortnight.

The primary objective of the study was to evaluate whether treatment with Ruxolitinib could keep patients out of the ICU and reduce fatalities.

RUXCOVID is a global, randomized, double-blind, placebo-controlled, 29-day, multi-center Phase III study evaluating the efficacy and safety of ruxolitinib plus standard of care (SoC) therapy in patients aged ≥12 years with COVID-19 associated cytokine storm.
On December 14, 2020, Novartis announced:

Phase III study did not meet its primary endpoint of reducing the number of hospitalized COVID-19 patients who experienced severe complications (death, mechanical ventilation or ICU care)

“While the RUXCOVID trial did not give us the results we hoped for, we will continue working with the medical community to analyze its findings to better understand COVID-19 and the role of JAK inhibition,” said John Tsai, Head, Global Drug Development and Chief Medical Officer, Novartis.

The results of RUXCOVID do not affect any ongoing trials for ruxolitinib in non-COVID-19 diseases.

Last updated: December 26th, 2025

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