MONTREAL, Canada - A major clinical trial shows that an inflammatory drug called colchicine is effective in treating COVID-19 and reduces the risk of complications from the disease, doctors in Canada said.
The results of the study are a "major scientific discovery" and make colchicine — a medicine used to treat gout — "the world's first oral drug that could be used to treat non-hospitalized patients with COVID-19," the Montreal Heart Institute said in a statement late Friday.
The study results show that colchicine reduced by 21 percent the risk of death or hospitalizations in patients with COVID-19 compared to placebo, the institute said.
The study was carried out in Canada, the US, Europe, and South America among a population of 4,488 patients.
In 4,159 of these patients, in whom the diagnosis of COVID-19 was proven by a naso-pharyngeal PCR test, use of colchicine reduced hospitalizations by 25 percent, the need for mechanical ventilation by 50 percent, and deaths by 44 percent, the study concluded.
Colchicine is effective in preventing dangerous inflammatory syndromes called "cytokine storms" and reducing complications associated with COVID-19, said Dr. Jean-Claude Tardif, director of the MHI Research Center and principal investigator in this study.
"We are pleased to offer the first oral medication in the world whose use could have a significant impact on public health and potentially prevent COVID-19 complications for millions of patients," Tardif said.
The study was conducted among COVID-19 patients not hospitalized at the time of enrollment in the trial, and with at least one risk factor for COVID-19 complications.
"This is the world's largest study testing an orally administered drug in non-hospitalized patients with COVID-19," the heart institute said.
Severe reaction to Moderna vaccine 'rare'
Severe allergic reaction to Moderna's COVID-19 vaccine is "rare," US health authorities said Friday, with only 10 cases arising from more than four million first doses.
The Centers for Disease Control and Prevention also emphasized that widespread vaccination was critical to fighting the coronavirus pandemic.
"Based on this early monitoring, anaphylaxis after receipt of Moderna COVID-19 vaccine appears to be a rare event," the CDC said in a report, indicating that none of the reactions resulted in death.
The CDC data documented the 10 cases of anaphylactic shock among a reported 4,041,396 first doses administered between December 21 and January 10.
They were recorded among 108 possible allergic reactions, the CDC said, with six of the cases requiring hospitalization, while the other four were treated in an emergency department setting.
The numbers represent 2.5 cases of anaphylactic shock per one million Moderna injections, compared with 11.1 cases per one million Pfizer injections, according to the CDC study.
"The clinical and epidemiologic characteristics of anaphylaxis case reports after receipt of Moderna COVID-19 vaccine are similar to those reported after receipt of the Pfizer-BioNTech COVID-19 vaccine," the CDC said.