Retrospective Study of ImmunoFormulation for COVID-19

Retrospective Observational Study to Describe the Evolution of SARS-CoV-2 Disease and the Profile of Patients Treated or Not With Imuno TF® and a Combination of Nutraceuticals and Who Have Tested Positive for COVID-19

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Dietary supplement: ImmunoFormulation

Detailed Description

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 (Actual): 40

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08022
    • Clinic Bascoy
  • Barcelona, Spain, 08037
    • Clínica Arvila Magna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

It was planned to collect data from approximately 40 patients who had tested positive in a diagnostic test for SARS-CoV-2: 20 patients who have been treated with IMUNO TF® with a combination of nutraceuticals and 20 patients who have not been treated with the investigational product.

All patients who met the screening criteria and gave their informed consent to participate were included consecutively.

Description

Inclusion Criteria:

1. Patients aged 18 years or older.
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:

1. Any medical or psychological condition that, in the physician's opinion, could compromise the patient's ability to give informed consent.
2. Patients requiring hospital admission due to the disease.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ImmunoFormulation cohort; Patients treated* with IMUNO TF® with a combination of nutraceuticals. *Without restrictions on the adjuvant treatment received.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month, starting with after start of treatment.

Collaborators and Investigators

• Sponsor: Fagron Iberica S.A.U.
• Investigators: Study Director: Hudson Polonini, PhD, Global Innovation Project Manager

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Actual): September 29, 2020
• Study Completion (Actual): September 29, 2020

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IMUNO TF STUDY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No