Retrospective Study of ImmunoFormulation for COVID-19

Completed

• Conditions: Covid19
• Interventions: Dietary Supplement: ImmunoFormulation

• Registration Number: NCT04666753
• Lead Sponsor: Fagron Iberica S.A.U.

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.

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 Timeline

• Study Start: 2020-07-02
• Primary Completion: 2020-09-29
• Study Completion: 2020-09-29
• Status Verified: 2020-12
• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-11
• Last Update Submitted: 2020-12-11
• Study First Posted: 2020-12-14
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Clinic Bascoy; 🇪🇸 Barcelona, Spain

Clínica Arvila Magna; 🇪🇸 Barcelona, Spain