Clinical trial NCT04666753: Retrospective Study of ImmunoFormulation for COVID-19
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Fagron Iberica S.A.U.
Sponsor class: INDUSTRY
First posted: 2020-12-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical symptoms duration
timeFrame: 1 month, starting with after start of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Clinic Bascoy
city: Barcelona
country: Spain
facility: Clínica Arvila Magna
Study officials:
affiliation: Global Innovation Project Manager
name: Hudson Polonini, PhD
role: STUDY_DIRECTOR
References: