COVID-19NCT04390477
Study to Evaluate the Effect of a Probiotic in COVID-19
A study testing Probiotic in people with COVID-19 and Coronavirus Infection, run by Bioithas SL at 2 sites in Spain.
Trial summary
A prospective case-control pilot study to evaluate the possible effect of a probiotic mixture in the improvement of symptoms, the reduction in the number of days of hospitalization and the increase in the percentage of patients with negative PCR after infection with the coronavirus SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Coronavirus Infection
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesSpain
- Study dates
- 4 May 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a confirmed diagnosis of SARS-Cov.2 infection using the PCR and that require admission to the hospitalization area.
Who cannot join
- Inability or refusal to sign informed consent.
- Allergy or intolerance to the intervention product or its components.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario del Vinalopó
Elche, Alicante, 03293
Hospital Universitario de Torrevieja
Torrevieja, Alicante, 03198
About this study
Official title: The Intestinal Microbiota as a Therapeutic Target in Hospitalized Patients With COVID-19 Infection
A prospective case-control pilot study to evaluate the possible effect of a probiotic mixture in the improvement of symptoms, the reduction in the number of days of hospitalization and the increase in the percentage of patients with negative PCR after infection with the coronavirus SARS-CoV-2.
Read the detailed description
In this study, the investigators hypothesize a positive effect of probiotic on the gut microbiome that could led to produce a less severe clinical evolution of the disease.
- Conditions
- COVID-19, Coronavirus Infection
- Being tested
- Probiotic
- Keywords
- Probiotic
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Oral daily capsule containing probiotic strains with maltodextrin as excipient, administrated for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | 1 pill od containing 1x10E9 cfu of the probiotic Receives: Dietary Supplement: Probiotic |
| Control | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cases with discharge to ICU.
Percentage of patients with discharge to ICU.
Measured: 30-days
Patients with resolution of digestive symptoms
Percentage of patients with improvement between the initial and final visits
Measured: 30 days
Secondary outcomes (6)
Patients with home discharge.
Percentage of patients with home discharge.
Measured: 30-days
Mortality.
Percentage of deaths.
Measured: 30-days
Treatment safety assessed by number of adverse events.
Number of adverse events that occur during the treatment period, attributable or not to the intervention product.
Measured: 30-days
New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients.
Number of new cases of positive SARS-Cov-2 infection by PCR analysis.
Measured: 30-days
Patients with negative PCR and/or Antigen test result for SARS-CoV-2 infection.
Percentage of patients with negative test for SARS-CoV-2.
Measured: 10-15 days
Patients with resolution of non-digestive symptoms
Percentage of patients with improvement between the initial and final visits
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start4 May 2020
- Primary completion21 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioithas SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vicente Navarro, Principal investigator, Hospital universitario del Vinalopo, Elche, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390477
- Sponsor's protocol ID
- COVID.PROB
- Status last verified
- Jul 2021
- First submitted
- 7 May 2020
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intestinal Microbiota as a Therapeutic Target in Hospitalized Patients With COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04390477
- Acronym / sponsor ID
- COVID.PROB
- Conditions
- COVID-19, Coronavirus Infection
- Keywords
- Probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Bioithas SLIndustry (pharma, biotech, devices)
- Study start
- 4 May 2020 (actual)
- Primary completion
- 21 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective case-control pilot study to evaluate the possible effect of a probiotic mixture in the improvement of symptoms, the reduction in the number of days of hospitalization and the increase in the percentage of patients with negative PCR after infection with the coronavirus SARS-CoV-2.
Detailed description
In this study, the investigators hypothesize a positive effect of probiotic on the gut microbiome that could led to produce a less severe clinical evolution of the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic1 pill od containing 1x10E9 cfu of the probiotic |
| Control | No intervention | –No treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a confirmed diagnosis of SARS-Cov.2 infection using the PCR and that require admission to the hospitalization area.
Key exclusion criteria (2 listed)
- Inability or refusal to sign informed consent.
- Allergy or intolerance to the intervention product or its components.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticOral daily capsule containing probiotic strains with maltodextrin as excipient, administrated for 30 days. | Dietary supplement | Probiotic |
Primary outcome
Cases with discharge to ICU.
Time frame: 30-days
Percentage of patients with discharge to ICU.
Patients with resolution of digestive symptoms
Time frame: 30 days
Percentage of patients with improvement between the initial and final visits
6 secondary outcomes
Patients with home discharge.
Time frame: 30-days
Mortality.
Time frame: 30-days
Treatment safety assessed by number of adverse events.
Time frame: 30-days
New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients.
Time frame: 30-days
Patients with negative PCR and/or Antigen test result for SARS-CoV-2 infection.
Time frame: 10-15 days
Patients with resolution of non-digestive symptoms
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicente Navarro principal investigator
Hospital universitario del Vinalopo, Elche, Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with COVID-19 and Coronavirus Infection, run by Bioithas SL at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cases with discharge to ICU. (time frame: 30-days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.