With the «Randomized, controlled, double-blind, multicenter clinical study to compare the efficacy and safety of the administration of two formulations of equine anti-SARS-CoV-2 immunoglobulins (“ S ”and“ M ”) in hospitalized patients with COVID-19 (SECR-01) », the Costa Rican Social Security Fund (CCSS) marks a milestone in the development of interventional clinical research, informed Dr. Juan Carlos Esquivel Sánchez, director of the Center for Strategic Development and Information on Health and Social Security (CENDEISSS) .
Dr. Esquivel Sánchez indicated that since the 1990s this type of study had not been developed since, for a period of time, the country did not have a law regulating this matter. In 2014, Law 9234 Regulating Biomedical Research was approved in Costa Rica.
Cendeisss, as part of the strengthening of this activity in the CCSS, prepared with the Health Commission of the Board of Directors a proposal for a biomedical research regulation that is under legal analysis prior to its presentation to this higher body. “We hope to present it to the authorities in the coming weeks,” said the director.
This SECR-01 study represents an important step in the development of institutional research given that there is an installed capacity of human, administrative, logistical and technological resources, as detailed by Dr. Esquivel Sánchez.
There will be a principal investigator, an official from the San Juan de Dios hospital, Dr. Alfredo Sanabria Castro, as well as a group of secondary investigators: for the CEACO, Dr. Alonso Acuña Feoli; for San Juan de Dios, Dr. Mario Sibaja Campos, Dr. Juan Ignacio Silesky, and Dr. Ann Echeverri Mccadless; for Mexico, Dr. Henry Chihong Chang Cheng, and for Calderón Guardia, Dr. José Pablo Madrigal Rojas.
This group of professionals will be accompanied by ten general practitioners who are the clinical coordinators distributed in each medical center, under the administrative and logistical coordination of Cendeisss, according to the agreement of the Board of Directors, in session N ° 9120, last August 20 .
It is a professional body highly trained in research and good clinical practices, in addition, all members are registered as researchers before the National Council for Health Research (CONIS).
For the start-up, it was necessary to put into practice medical-administrative, logistical and technological development strategies, as explained by the director of Cendeisss. “This shows that the CCSS has all the necessary resources to carry out this type of investigation. This SECR-01 study is expected to be one of many more that the CCSS will sponsor and develop in favor of Costa Rican public health, which will also contribute to international scientific knowledge ”.
The SECR-01 and any other study that is developed in the CCSS, will be attached to all the ethical standards that include institutional, national and international regulations, where safety and human life prevail.