Novartis (NVS) said Monday that it had reached an agreement with the U.S. Food and Drug Administration to conduct a study of the much publicized anti-malaria drug hydroxychloroquine as a treatment for the coronavirus.
The Basel drugmaker's American depositary receipts at last check were little changed at $89.23.
A Phase III clinical study will be tested against a placebo alone and in combination with the antibiotic azithromycin with about 440 patients to evaluate the use of hydroxychloroquine, Novartis said.
The company is recruiting covid-19 patients with moderate-to-severe illness for a study in which neither patients nor doctors know who’s receiving the drug.
Novartis said it hoped to have results as soon as early summer. The company said it planned to test 200-milligram doses three times a day, after a dose of 600 milligrams on the first day of treatment.
The trial will be conducted at more than a dozen sites in the U.S. Novartis said it planned to begin enrollment for this study within the next few weeks.
The clinical-trial drug supply will be provided by Sandoz, Novartis's generics and biosimilars division.
Hydroxychloroquine, which has been used to treat malaria and certain autoimmune diseases, has been touted by President Donald Trump. Doctors have warned that the drug can cause heart problems.
“We are donating hydroxychloroquine tablets for Covid-19 patients, including for use in this and other clinical trials, with the hope that researchers and healthcare workers can quickly and scientifically determine whether hydroxychloroquine can help patients around the world combat this disease,” Richard Saynor, chief executive of Sandoz, said in a statement.