Multicentre, retrospective, observational study 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.
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. 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. The mean duration of mild/moderate symptoms of COVID-19 was 11.5±5.7 days. 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. Assuming a loss of 10% of patients, the sample size was 20 patients. 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. The calculations were performed with the help of the PASS package, version 2011. DATA PROCESSING Study data were collected in a CRD and inserted the data in a database specifically designed for the study. The database included internal consistency ranges and rules to ensure data quality control.
Study Type
OBSERVATIONAL
Enrollment
40
The ImmunoFormulation consist of: transfer factors (oligo- and polypeptides from porcine spleen, ultrafiltered at \<10 kDa - Imuno TF®) 100 mg, 800 mg anti-inflammatory natural blend (Uncaria tomentosa, Endopleura uchi and Haematoccocus pluvialis - MiodesinTM), 60 mg zinc orotate, 48 mg selenium yeast (equivalent to 96 μg of Se), 20,000 IU cholecalciferol, 300 mg ascorbic acid, 480 mg ferulic acid, 90 mg resveratrol, 800 mg spirulina, 560 mg N-acetylcysteine, 610 mg glucosamine sulphate potassium chloride, and 400 mg maltodextrin-stabilized orthosilicic acid (equivalent to 6 mg of Si - SiliciuMax®).
Clinic Bascoy
Barcelona, Spain
Clínica Arvila Magna
Barcelona, Spain
Clinical symptoms duration
To describe the course of SARS-CoV-2 disease in patients treated or not with ImmunoFormulation and who have tested positive in a diagnostic test for COVID-19 based on the duration of symptoms.
Time frame: 1 month, starting with after start of treatment.
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