Shenyang Tonglian Group is set to initiate a clinical study of Carrimycin for the treatment of severe Covid-19 in hospitalised patients after it received US Food and Drug Administration (FDA) approval.
Carrimycin is a safe and effective compound administered as a film-coated tablet.
Marketed in China, the drug has shown a positive effect on the outcome for hospitalised Covid-19 patients in the country.
Planned to begin in early January next year, the randomised, multi-centre, placebo-controlled, double-blind clinical study will evaluate the safety and efficacy of Carrimycin for treating severe Covid-19.
It will be conducted in the US, Mexico, Brazil, Philippines, Ukraine, Argentina, Peru, Colombia and India.
The study’s primary endpoints will be efficacy and safety, being the recovery rate defined as the number of participants alive without needing supplementary oxygen and ongoing medical care at day 28.
In addition, various other secondary efficacy and safety endpoints will be analysed.
The global trial will enrol 300 hospitalised adult patients who will be equally divided into experimental group and control group.
Participants will receive Carrimycin as two 200mg film-coated tablets once daily for 14 days.
Estimated to last for about six months, an interim analysis is anticipated to be conducted when half of the patients complete the assessment period for 28 days.
Shenyang Tonglian Group CEO Jiang Enhong said: “Our company is proud to have been actively supporting the anti-SARS-CoV-2 pre-clinical and clinical emergency initiatives in China.
“In view of the seriousness of the pandemic, Tonglian Group is keen to explore the potential of Carrimycin on the international stage to contribute to the global fight against Covid-19.”
The company noted that during the SARS-CoV-2 outbreak in China, Carrimycin effectively eliminated the virus quickly, significantly bettering clinical symptoms and pulmonary inflammation.
The drug could also reduce hospitalisation time and improve patient prognosis in three clinical trials.