Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04666116 |
| Other study ID # |
HdeSagunto |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2020 |
| Est. completion date |
February 2021 |
Study information
| Verified date |
December 2020 |
| Source |
Hospital de Sagunto |
| Contact |
xavier cortés |
| Phone |
0034962339300 |
| Email |
xacori[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The main objective of the study is to evaluate the capacity of a novel nutritional supplement
intervention including strains from the species Bifidobacterium longum, Bifidobacterium
animalis subsp. Lactis and Lactobacillus rhamnosus, plus vitamin D, zinc and seleniumt)
(immune system enhancer, antioxidant and anti-inflammatory capacity) to decrease the viral
load by nasopharyngeal smear in patients admitted for COVID-19 coronavirus disease.
Description:
1. Study hypothesis: Through the administration of specific probiotics, the immune response
against the coronavirus COVID-19 could be stimulated, being able to decrease its viral
load and secondary symptomatology.
There is a different way to attack a harmful microorganism. It is based on the existence
in its habitat of a whole complex network of other microorganisms, our microbiota, which
prevents the development, growth and feeding of that microorganism, either by
competition of space, food, or immune effects. In COVID-19 patients, intestinal
dysbiosis has been described, specifically observing the decrease of species considered
as probiotics of the genera Lactobacillus and Bifidobacterium. The current study
proposes the testing of the novel nutritional supplement to potential the patient's
immune system and balances the damaged microbiota. This product contains species from
the genera described as affected in the COVID-19 infection. Moreover, the strains
selected showed an anti-inflammatory and antioxidant effect, and capacity for
stimulation of the immune system in previous assays. All three strains have the GRAS
status recognized by the FDA and are on the EFSA QPS list. The product also contains
vitamin D, zinc and selenium, three powerful inducers of the immune response. It is a
safe product according to WHO criteria. In addition, it can be effective despite the
administration of antibiotics, due to postbiotic activity, reducing the risk of sepsis
described in this type of patient. In order to monitor the effects of treatment with the
functional product, a follow-up will be made by means of consultation regarding the
evolution of the patient's condition. On the other hand, we will try to correlate this
state with the viral load present in serum and pharyngeal-nasal scraping.
2. PRIMARY AND SECONDARY OBJECTIVES
Main objective: The main objective of the study is to evaluate the capacity of the novel
nutritional supplement (immune system enhancer, antioxidant and anti-inflammatory capacity)
to decrease the viral load by nasopharyngeal smear in patients admitted for COVID-19
coronavirus disease. The Patient will follow the medication agreed by the Hospital committee
during all the process.
Secondary objectives: Monitoring of changes, in patients admitted by COVID-19+, of the
following parameters at admission and prior to discharge:
- Hospital stay (days). Stay in Intensive Care Unit (days)
- Clinical indicators: Respiratory rate, body temperature, number of bowel movements and
consistency. Abdominal pain. Nausea and vomiting. Sat02.
- Type of respiratory support on day 5 of admission: ambient air (none), nasal mask,
ventimask, reservoir, non-invasive mechanical ventilation (NIV), orotracheal intubation.
- Analytical parameters at admission and discharge: Total lymphocytes, Hemoglobin,
Ferritin, Neutrophils, Urea/Creatinine, C-reactive protein, LDH, D-dimer, AST/ALT,
Platelets.
- Determination of the incidence of mortality in the patient cohort and comparison with
that described in the literature.
3. PRIMARY AND SECONDARY STUDY VARIABLES
3. 1. Primary study variable
- Viral load during the period of admission to the nasopharyngeal smear.
3. 2. Secondary study variables
- Hospital stay (days). Stay in Intensive Care Unit (days).
- Clinical indicators on admission and every 48 hours thereafter: Respiratory rate, oxygen
saturation, body temperature, number of bowel movements and consistency. Abdominal pain.
Nausea and vomiting.
- Type of respiratory support on the 5th day of admission: ambient air (none), nasal
glasses, ventimask, reservoir, non-invasive mechanical ventilation (NIV), orotracheal
intubation.
- Mortality.
- Analytical parameters at day 0 and at hospital discharge: Total lymphocytes, ferritin,
hemoglobin, neutrophils, urea/creatinine, C-reactive protein, IL-6, LDH, D-dimer,
AST/ALT, platelets
- Appearance of side effects.
4. MATERIAL AND METHODS
4.1. Study design Randomized clinical trial with a clinical intervention of prescription of
functional novel nutritional supplement. The expected duration is 3 months in all patients
presenting symptoms of infection by COVID-19 or COVID+.
Serum viral load will be analyzed by rt-qPCR (reverse transcriptase quantitative Polymerase
Chain Reaction) at the beginning of the patient's admission and every 48 hours until
remission of the infection and pharyngeal-nasal exudate.
The patient medicated according to hospital protocol will also be given a daily dose (one
sachet) until remission of the illness or for one month.
4.2. Sample size of the study According to GRANMO Sample Size Calculator (Version 7.12 April
2012) Accepting an alpha risk of 0.15 and a beta risk of 0.3 in a bilateral contrast, 48
subjects in the first group and 48 in the second are required to detect the difference
between two proportions as statistically significant, than for group 1 (intervention group)
it is expected to be 0.5 and group 2 0.7. A follow-up loss rate of 5% has been estimated. The
ARCOSENE approach has been used.
4.3. Statistical plan Quantitative variables will be expressed as mean and standard deviation
assuming normal distribution based on the central limit theorem.
Qualitative variables will be expressed as frequencies with their 95% confidence intervals.
Qualitative variables will be compared using the Chi-square test.
Quantitative variables will be compared using the Student T test. In order to evaluate the
impact of the intervention on the evolution of the disease by COVID-19, on average stay,
clinical variables and qualitative and quantitative analyses, a multivariate analysis will be
carried out, in which it will be controlled by different variables that could act as factors
of confusion (age, sex, type of disease, severity of the disease on admission, other diseases
that could affect the evolution, medical treatment, previous surgeries, etc.)
4.4. Planning the physical-sample drawing Main evaluation criteria: These patients will have
their surgery performed pharyngeal-nasal smear on day 0 and day 5 of hospital admission.
Viral load testing and cytokines: In the samples, the viral load will be determined by
rt-qPCR, in hospital services. Cytokines shall be measured at the indication of the physician
when deemed appropriate.
5. ETHICAL ASPECTS TAKEN INTO ACCOUNT IN THE STUDY PROTOCOL
5.1 Ethical conduct of the study
The study will be carried out in accordance with the following guidelines:
- Local ethical standards.
- European directives on the protection of human subjects in research.
- Declaration of Helsinki.
- The study will be conducted in strict accordance with the international ethical
recommendations for human research and clinical trials set out in the Declaration of
Helsinki, and in accordance with the recommendations of the Ministry of Health on
clinical trials.
- Recommendations of the European Network of Pharmacoepidemiology and Pharmacovigilance
Centres
- GMP recommendations.
- Other relevant guidelines, laws or regulations applicable in each country and in the
Valencian Community As it is a research project with a nutritional supplement, it is not
considered a medicine or a health product, and therefore the Biomedical Research Law
applies to it and not the EECC RD 1090/2015. Therefore, there is no need for
authorization by the AEMPS (State Agency for Medicines) or by the Conselleria de
Sanitat.
The study protocol will be submitted for prior approval to the Hospital de Sagunto IRB.
