Laydami Cárdenas González, coordinator of the Soberana Centro Clinical Trial in Palmira, thanked the municipality for the opportunity to participate in this clinical trial, which has had the support of mass organizations, which have been inserted and “have made this trial a process of spontaneity of the population in the territory ”.
The specialist explained to Cubadebate I know during Saturday and Sunday the identification of subjects to participate in the trial started, and recruitment by doctors’ offices started. In that sense, he pointed out that four clinics belonging to Palmira Sur and Palmira Norte were selected, two in each of these health areas.
“We are seeking to recruit 292 patients in each area, to reach a total of 584 people in the municipality,” said Cárdenas González.
The informed consent of the subjects is essential for the development of the research. Photo: Karina Rodríguez / Cubadebate.
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This process was carried out by the basic health teams, made up of the family’s doctors and nurses, added the researcher, who pointed out that All the conditions have been created to be able to develop the vaccination process from Monday to Wednesday.
For this trial, he specified, the municipality of Palmira has been divided into two health areas; concentrating a vaccination in the Manuel Piti Fajardo polyclinic and enabling another in a recreational center in the territory.
The coordinator of the Soberana Centro Clinical Trial in Palmira explained that once the subject agrees to recruitment, the main aspects of the clinical trial, their doubts are clarified, and once their consent to participate is obtained, they go to a comprehensive evaluation consultation, where a comprehensive physical examination is performed. In addition, an interrogation to ensure that he meets the inclusion criteria and then it can be part of the investigation, he stressed.
The subjects included in the trial are given vital signs, an antigen test to rule out that they are positive for the SARS-CoV-2 virus and if negative they go back to a consultation where they are evaluated navaly by a medical team. Photo: Karina Rodríguez / Cubadebate.
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He explained that once the subject is included, the vaccination date is assigned, a process where it is received by our staff, vital signs are taken, an antigen test to rule out that it is positive for the SARS-CoV-2 virus and If negative, he goes back to a consultation where he is navaously evaluated by a medical team. If there is no difficulty, the blood sample is taken, then it goes on to the vaccination where the vaccine candidate is administered and later to the observation area. At 24, 48 and 72 hours after being vaccinated, he is evaluated again by a medical team.
Once the vaccine candidate has been administered, the subjects are kept under observation for one hour, where they are evaluated and monitored. Photo: Karina Rodríguez / Cubadebate.
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Anaelys Regla Maceo Sinabele, clinical research assistant at the National Coordinating Center for Clinical Trials (CENCEC), stated that the conduct of the entire trial is constantly monitored by this center, ensuring strict compliance with good clinical practices.
He added that the subjects will also be followed up to 28 days after the application of the last dose.
Collective of health professionals and medical students that is part of the Soberana Centro trial in Palmira. Photo: Karina Rodríguez / Cubadebate.
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Dr. Yaniuska González López, municipal director of Health in Cruces, pointed out that the territory has had the privilege of being included in a study that is the result of a feat of Cuban science and the Revolution. “Starting this study on July 26, a day of special significance for the history of our country, is a great joy,” he said.
He explained that in Cruces, Soberana Centro also began with the recruitment of volunteers between Saturday and Sunday, a process well accepted by the population of the territory. The aforementioned patients attended the vaccination without difficulty, where the protocol established in the different stations has been developed, such as taking vital signs, application of the antigen test, consultation for the inclusion of subjects, blood collection and application of the vaccine. Once the vaccine candidate has been administered, patients are kept under surveillance for one hour.
Until 2:00 pm they had been vaccinated about 40 people, all in perfect health and without complications or reactions to the processGonzález López said.
Two vaccinations were enabled in the municipality (Círculo Infantil Florecitas del 2000 and the Family Medical Clinic number 15), where About 600 people will be vaccinated as part of the trial.
Soberana Centro clinical trial in the Cruces municipality, Cienfuegos. Photo: Karina Rodríguez / Cubadebate.
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Soberana Centro clinical trial in the Cruces municipality, Cienfuegos. Photo: Karina Rodríguez / Cubadebate.
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Soberana Centro clinical trial in the Cruces municipality, Cienfuegos. Photo: Karina Rodríguez / Cubadebate.
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Volunteers are evaluated at inclusion visits to verify that they meet the criteria for participation in the trial. Photo: Karina Rodríguez / Cubadebate.
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