Retrospective Study of ImmunoFormulation for COVID-19

• Sponsor: Fagron Iberica S.A.U. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04666753
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Actual Duration (Months): 2.9
• Patients Per Site: 20
• Patients Per Site Per Month: 6.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	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 Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: 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
• Actual Study Start Date: Jul 2, 2020
• Actual Primary Completion Date: Sep 29, 2020
• Actual Study Completion Date: Sep 29, 2020

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Clinical symptoms duration [1 month, starting with after start of treatment.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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:

4. IMUNO TF® cohort: patients treated* with IMUNO TF® with a combination of nutraceuticals

5. Control cohort: patients not treated* with IMUNO TF® with a combination of nutraceuticals *Without restrictions on the adjuvant treatment received.

6. Patients who have tested positive in a diagnostic test for SARS-CoV-2.

7. Patients with onset of COVID-19 symptoms ≥ 5 days prior to diagnosis of SARS-CoV-2.

8. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinic Bascoy	Barcelona		Spain	08022
2	Clínica Arvila Magna	Barcelona		Spain	08037

Sponsors and Collaborators

• Fagron Iberica S.A.U.

Investigators

• Study Director: Hudson Polonini, PhD, Global Innovation Project Manager

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fagron Iberica S.A.U.
• ClinicalTrials.gov Identifier: NCT04666753
• Other Study ID Numbers: IMUNO TF STUDY
• First Posted: Dec 14, 2020
• Last Update Posted: Dec 14, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Dec 14, 2020