The first patients were dosed this week in a clinical trial testing the arthritis drug Kevzara. The companies hope to enroll 400 COVID-19 patients.
- Drugmakers are testing a drug that's currently used to treat arthritis against the novel coronavirus.
- Pharma companies Sanofi and Regeneron said Monday that they started a trial, and are looking to enroll 400 patients in New York. They eventually plan to test the drug, called Kevzara, across the globe.
- The US study is already underway, recruiting patients at two prominent healthcare providers in New York: Northwell Health and the Mount Sinai Health System. Northwell dosed the first two patients on March 17.
- "In my over 20 years of being a part of clinical research, we have never been able to move that quickly before," said Christina Brennan, vice president of clinical research at Northwell Health's Feinstein Institutes for Medical Research at a Friday press conference.
- There are no approved treatments or vaccines for the coronavirus. Many pharma and biotech companies have started research programs in the last few weeks as the outbreak has worsened into an official pandemic.
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A new coronavirus clinical trial has started to test COVID-19 patients in the US, starting in New York.
The French pharma giant Sanofi and New York biotech company Regeneron said Monday they have kicked off a global testing program for Kevzara as a treatment for severe cases of COVID-19, the disease caused by the coronavirus pandemic.
Currently, there are no approved treatments or vaccines for the coronavirus. Kevzara was approved in the US in 2017 to treat rheumatoid arthritis. The drug works by inhibiting a biological mechanism that may drive the overactive inflammatory response to COVID-19 patients' lungs, the companies said.
Regeneron will lead trials in the US, while Sanofi will lead plans for studies in other countries. They are testing Kevzara only in COVID-19 patients who are hospitalized and have serious complications from the infection.
The study is underway, with the first patients being dosed on March 17. Two prominent healthcare providers in New York in Northwell Health and the Mount Sinai Health System are now recruiting patients. It took four days to get the trial running, hospital and company officials said at a March 20 press conference.
"In my over 20 years of being a part of clinical research, we have never been able to move that quickly before," said Christina Brennan, vice president of clinical research at Northwell Health's Feinstein Institutes for Medical Research.
Patients will need to have a COVID-19 case classified as severe or critical, or be suffering from multi-organ dysfunction. All patients must have pneumonia and fever in order to enroll.
This first US study will start at New York medical centers. It will test a combination of Kevzara and usual supportive care against a placebo-controlled arm. Study participants will be randomly assigned to one of three options: a low dose of Kevzara, a high dose of Kevzara, or the placebo.
The trial will be split into two parts. The first portion will evaluate Kevzara's impact on fever and patients' need for supplement oxygen, according to the companies.
The second part will test longer-term outcomes, such as preventing death and reducing the need for mechanical ventilation. After the first portion is finished, the companies can tinker with some of the study specifics based on the early findings, such as changing an endpoint or the dosing strength.
Both drugmakers have other ongoing COVID-19 research projects. Sanofi is expecting to start a clinical trial in early 2020 for a vaccine it is developing, while Regeneron is aiming to start testing an experimental antibody treatment later this summer.