On 23 March 2020, the Romanian Ministry of Health issued Order No 487/2020 for the approval of a protocol for the treatment of the infection associated with the SARS-Cov-2 virus, also known as the coronavirus.
This Order came into force on 24 March 2020.
The Ministry of Health acknowledges that there are currently no approved medicines for treating COVID-19, the disease caused by SARS-Cov-2, and that the medicines proposed in the protocol are based on research conducted during the 2003 SARS and 2012 MERS epidemics, and on the data gathered so far on the coronavirus. (The Order cites international medical evidence, including the Wang et al., 2020 study and Gao și colab., 2020 study).
Pursuant to the protocol, treatment for COVID-19 appears to depend on the severity of the infection with no medication prescribed for asymptomatic patients, Paracetamol for mild forms of the disease and a variety of medicines, in various doses and combinations, for severe and chronic cases. The medicines used in serious cases include the experimental antiviral compound Remdesivir, the malaria medication hydroxychloroquine, the HIV drugs lopinavir and ritonavir, and the immunosuppressive drug Tocilizumab.
This protocol is part of the worldwide efforts to find a cure for COVID-19, coming in the context of the recent launch by the World Health Organisation (WHO) of the global megatrial SOLIDARITY, which is testing the four most promising coronavirus treatments. The drugs on SOLIDARITY trial include those mentioned in Order No 487/2020.
For more information on this Order and Romania’s pharmaceutical and pharma research industries, contact local CMS expert Valentina Parvu or your regular CMS advisor.