Patients who have consulted their physician for symptoms associated with SARS-CoV-2 infection between March 2020 and May 2020. Patients who give written informed consent to participate in the study.The database included internal consistency ranges and rules to ensure data quality control. The calculations were performed with the help of the PASS package, version 2011.ĭATA PROCESSING Study data were collected in a CRD and inserted the data in a database specifically designed for the study. Considering the two groups of patients (treated with IMUNO TF® / not treated with IMUNO TF®), the sample size was 40 patients, 20 patients per group. Assuming a loss of 10% of patients, the sample size was 20 patients. A sample of 18 patients would be sufficient to estimate, with a 95% confidence and a precision of +/- 2.8 days, a mean duration of symptoms with a standard deviation of 5.7 days. The mean duration of mild/moderate symptoms of COVID-19 was 11.5±5.7 days. Sample size calculation was established according to the ICH guidelines, where it was specified that the number of patients should be sufficient to provide a safe response about the issues raised. SAMPLE SIZE JUSTIFICATION The primary objective of the study was to describe the course of SARS-CoV-2 disease in patients treated or not with IMUNO TF® and a combination of nutraceuticals and who have tested positive in a COVID-19 diagnostic test based on the duration of symptoms. Why Should I Register and Submit Results?.
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