Introduction: Patients diagnosed with end-stage chronic kidney disease on a hemodialysis program (HDP) represent a risk group for COVID-19. Scientific societies have developed guidelines for the prevention of contagion, but there is no prophylactic medicine in them. Objectives: To describe the safety and efficacy of recombinant intranasal human Interferon alfa 2b as prophylaxis for COVID-19 in patients in an HDP. Patients and Methods: Intervention description through the monitoring of 15 patients in outpatient HDP. Prior to the administration of the drug, clinical, radiological evaluation and hematology and blood chemistry studies were performed. Daily contact was made with each study patient in person or by telephone, asking about the occurrence of adverse events or symptoms of disease. Results: In 47% of the patients, there was leukopenia, lymphopenia in 67% and anemia and thrombocytopenia in 33% respectively, prior to the use of the drug. There was no clinical suspicion of COVID-19 in any of them. Adverse events occurred in 3 patients (20%), all were mild and non-severe. All patients were negative for SARS-CoV-2 real-time polymerase chain reaction (rtPCR) and antibody studies 45 days after the study started. Conclusion: the use of intranasal recombinant human interferon alfa 2b as prophylaxis of COVID-19 in patients in a HDP at a dose of 1 MIU daily for ten days, as part of a prevention protocol, has an adequate safety profile. None of the patients in the series was infected with SARS-CoV-2 during the surveillance period.
An interventional, phase 4, single group assignment, without masking (open label), preventive clinical trial was carried out in health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B. Methods: 67 health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B, were enrolled in the Clinical Trial. All participants were from 18 years up to 64 years old. Inclusion Criteria: NHS workers -including university students doing their internships in health centres dependent on the National Health System (inclusion of students is regulated and limited by specific instructions on labour prevention in each autonomous community)-classified as non-responders. The criteria defining them as non-responders to the conventional hepatitis B vaccine is anti HBsAb titers < 10 mUI/ml following the application of six doses of conventional vaccine at 20 lg doses (two complete guidelines). The objective of this study was to provide Health workersstaff with an additional protection tool against hepatitis B infection, and to evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine. The primary outcome was the measurement of antibody antiHBs before the first Fendrix Ò dose and a month after the administration of each dose. Other outcome was collection of adverse effects during administration and all those that could be related to the vaccine and that occur within 30 days after each dose. In this study, only one group was assigned. There was no randomization or masking. Results: The participants were recruited between April 13, 2018 and October 31, 2019. 67 participants were enrolled in the Clinical Trial and included the analyses. The primary immunisation consists of 4 separate 0.5 ml doses of Fendrix Ò , administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once the positivity was reached in any of the doses, the participant finished the study and was not given the following doses. 68.66% (46 out 67) had a positive response to first
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