Retrospective Study of ImmunoFormulation for COVID-19

NCT04666753 | Completed

• 1 other identifier: IMUNO TF STUDY
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

ImmunoFormulation cohort

Patients treated\* with IMUNO TF® with a combination of nutraceuticals. \*Without restrictions on the adjuvant treatment received.

Dietary Supplement: ImmunoFormulation

Control cohort

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

Interventions

ImmunoFormulation DIETARY_SUPPLEMENT

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®).

ImmunoFormulation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients aged 18 years or older.
• Patients who give written informed consent to participate in the study.
• 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:
• IMUNO TF® cohort: patients treated\* with IMUNO TF® with a combination of nutraceuticals
• Control cohort: patients not treated\* with IMUNO TF® with a combination of nutraceuticals \*Without restrictions on the adjuvant treatment received.
• Patients who have tested positive in a diagnostic test for SARS-CoV-2.
• Patients with onset of COVID-19 symptoms ≥ 5 days prior to diagnosis of SARS-CoV-2.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fagron Iberica S.A.U.: lead

Study Sites (2)

Clinic Bascoy

Barcelona, 08022, Spain

Location

Clínica Arvila Magna

Barcelona, 08037, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hudson Polonini, PhD

  Global Innovation Project Manager

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 14, 2020
• Study Start: July 2, 2020
• Primary Completion: September 29, 2020
• Study Completion: September 29, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

ES (2)