The first of three consignments of casirivimab-imdevimab, also known as REGN-CoV2 (manufactured by Regeneron / Roche), was received this morning by 2 units at the University Hospital in Motol. Together with the Brno University Hospital, it also coordinates the distribution of the drug to other hospitals. A total of 000 doses of this product should arrive in the Czech Republic through three deliveries (March, April, May).
The product is not registered anywhere in the world yet. In the United States, it obtained the so-called EUA (Emergency Use Authorization), in the Czech Republic it is temporarily approved for use by the Ministry of Health of the Czech Republic by a similar mechanism under the Pharmaceuticals Act. "The main purpose is to protect the most at-risk patients from the severe course of covid-19 and thus alleviate the current enormous pressure on congested hospitals." emphasizes JUDr. Ing. Miloslav Ludvík, MBA, director of the University Hospital in Motol.
Both hospitals will be the main coordinators for the whole Czech Republic. The individual hospitals will order the medicine from them. FN Motol will provide REGN-CoV2 to hospitals in Prague, as well as in the Central Bohemian, South Bohemian, Plzeň, Karlovy Vary, Liberec and Ústí regions. The others will be supplied from the Brno University Hospital. They should send their order to the coordinating hospitals no later than about a week before the announced delivery (for current orders see pdf TZ - REGN-COV2 - Appendix No. 1). Roche will then take them to hospitals according to the schedule.
The product is intended primarily for outpatients at risk of severe covid-19, or for patients hospitalized for a cause other than covid-19. However, it is not intended for patients who are hospitalized due to the severe course of covid-19.
Patients for whom this type of treatment will be suitable must meet the given indication criteria given by the Decision of the Ministry of Health of the Czech Republic. These include, for example, transplant patients, oncology and haematooncology patients with ongoing treatment, patients with autoimmune diseases, severe lung diseases, patients with type I diabetes mellitus (diabetes) and other selected groups of patients at risk (see pdf TZ - REGN-COV2 - Annex No.2).
"Due to the indication criteria and the relatively short time window during which it is to be administered, the product is primarily intended for pre-hospital care of high-risk patients. It should effectively prevent the deterioration of their clinical condition with the need for hospitalization, " presents doc. MUDr. Tomáš Vymazal, PhD, MHA, Head of KARIM 2nd Faculty of Medicine, Charles University and University Hospital Motol.
Patients can be indicated for the administration of the product by both general practitioners and outpatient specialists, as well as hospital physicians. "In order to ensure that REGN-CoV2 is available as quickly as possible to needy patients within the regions, we contacted not only the governors, but also the individual hospitals and their hospital pharmacies. We discussed all the necessary information together and agreed on professional and logistical details, " says PharmDr. Petr Horák, chief pharmacist at the Motol University Hospital. FN Motol also asked the Association of General Practitioners and individual professional societies for cooperation. "Given the relatively short time window at the onset of the disease when the product needs to be administered, good information and rapid response are essential." supplied by PharmDr. Burner.
Due to the fact that the drug is administered intravenously (so-called infusion), the patient will have to come to one of the hospitals, which will be designated for its administration by the Ministry of Health. Each of the hospitals authorized in this way will create a so-called "infusion point" in its premises, where the drug will be administered. The application itself is not complicated at all. This is a single infusion lasting about 1 hour. The patient must then remain at the infusion site for another hour for observation. Administration of REGN-CoV2 must be accompanied by conclusive monitoring of clinical data in each patient to evaluate efficacy and safety. At the Motol University Hospital, this infusion site will be set up on the premises of the Pneumology Clinic.
Casirivimab-imdevimab, also known as REGN-CoV2 (manufactured by Regeneron / Roche), contains two monoclonal antibodies against the so-called S-protein (spike protein) of the new coronavirus SARS-CoV2. S-protein is a viral protein that allows the virus to bind to the target site of host cells (in our case in humans) and thus infect and further multiply. It is the same protein that our body actually "produces" after the administration of mRNA vaccines, which triggers the vaccinated person's own immune response with the production of antibodies.
However, unlike vaccines, casirivimab-imdevimab works immediately by binding to virus targets. This is because each of the antibodies binds to a different site on the S-protein. This prevents it from infecting the cells and multiplying further. Therefore, its administration is very suitable in patients at high risk of severe covid-19 disease, right at the beginning of the disease, which was confirmed by a positive PCR test and in the presence of mild symptoms that do not last longer than 7 days.
Press Release:
TZ - REGN-COV2 (336,65 KB)
