Fostamatinib of no benefit in COVID-19 patients with hypoxemia

In the treatment of hospitalized adults with COVID-19 and hypoxemia, the use of the spleen tyrosine kinase inhibitor fostamatinib does not appear to have any positive effect on the number of oxygen-free days as compared with placebo, according to the results of a phase III trial.

A total of 400 hospitalized adult patients (median age 67 years, 52.5 percent men) with acute SARS-CoV-2 infection and hypoxemia participated in the trial. These patients were randomly assigned to receive treatment with fostamatinib at 150 mg or placebo, administered orally twice daily for 14 days.

The primary outcome of oxygen-free days at day 28 was evaluated based on mortality and duration of supplemental oxygen use. All-cause mortality at 28 days was the secondary outcome. Safety outcomes included elevated transaminase values, neutropenia, and hypertension.

No significant difference in the mean number of oxygen-free days at day 28 was seen between the fostamatinib group and the placebo group (13.4 vs 14.2 days; adjusted odds ratio [aOR], 0.82, 95 percent credible interval [CrI], 0.58–1.17).

At day 28, 11.3 percent of patients in the fostamatinib group and 8.1 percent in the placebo group had died, with the aOR for mortality being 1.44 (95 percent CrI, 0.72–2.90).

As for safety, aspartate aminotransferase elevation occurred with greater frequency in the fostamatinib group than in the placebo group (11.6 percent vs 5.5 percent; aOR, 2.28, 95 percent CrI, 1.07–4.84). No other safety outcomes differed between the two groups.