The clinical study of the two anti-SARS-Co-V2 equine immunoglobulin formulations marks a historic milestone in the development of interventional clinical investigations in the CCSS, said Juan Carlos Esquivel Sánchez, director of the Center for Strategic Development and Information on Health and Social Security (CENDEISSS), managing institute of the study.
Dr. Esquivel Sánchez indicated that this type of study had not been carried out since the country did not have a law regulating this matter until the Law 9234 Regulating Biomedical Research in Costa was approved in 2014.
This is 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) “that arise from the clinical testing phase of the formulations developed at the Clodomiro Picado Institute of the University of Costa Rica with the participation of the CCSS.
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 before its presentation to this higher office. “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, according to 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 No. 9120, on August 20th.
It is a professional organization highly trained in research and good clinical practices, also, all members are registered as researchers with 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 th e CCSS has all the necessary resources to carry out this type of investigation.
The SECR-01 study is expected to be one of many more that the CCSS will sponsor and develop for the benefit of the Costa Rican public health system, 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 ethical standards that include institutional, national, and international regulations, where safety and human life prevail.