Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2020-07-02
2020-09-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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ImmunoFormulation cohort
Patients treated\* with IMUNO TF® with a combination of nutraceuticals.
\*Without restrictions on the adjuvant treatment received.
ImmunoFormulation
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®).
Control cohort
Control cohort: patients not treated\* with IMUNO TF® with a combination of nutraceuticals.
\*Without restrictions on the adjuvant treatment received.
No interventions assigned to this group
Interventions
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ImmunoFormulation
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®).
Eligibility Criteria
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Inclusion Criteria
2. Patients who give written informed consent to participate in the study.
3. Patients who have consulted their physician for symptoms associated with SARS-CoV-2 infection between March 2020 and May 2020. Patients were included in one cohort or the other based on the treatment received for improvement of COVID-19 symptoms:
1. IMUNO TF® cohort: patients treated\* with IMUNO TF® with a combination of nutraceuticals
2. Control cohort: patients not treated\* with IMUNO TF® with a combination of nutraceuticals \*Without restrictions on the adjuvant treatment received.
4. Patients who have tested positive in a diagnostic test for SARS-CoV-2.
5. Patients with onset of COVID-19 symptoms ≥ 5 days prior to diagnosis of SARS-CoV-2.
6. Patients with data in the medical record from the first visit due to disease symptoms until recovery, or at least 1 month of follow-up of symptoms, whichever occurs first.
Exclusion Criteria
2. Patients requiring hospital admission due to the disease.
18 Years
ALL
No
Sponsors
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Fagron Iberica S.A.U.
INDUSTRY
Responsible Party
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Principal Investigators
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Hudson Polonini, PhD
Role: STUDY_DIRECTOR
Global Innovation Project Manager
Locations
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Clinic Bascoy
Barcelona, , Spain
Clínica Arvila Magna
Barcelona, , Spain
Countries
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Other Identifiers
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IMUNO TF STUDY
Identifier Type: -
Identifier Source: org_study_id