COVIDBACT-ovidNCT04368351
Bacteriotherapy in the Treatment of COVID-19
An observational study of COVID and Pneumonia, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
In light of its high morbidity and mortality, COronaVIrus Disease 19 (COVID-19) pandemic spread is considered an unprecedented global health challenge. Given the very limited therapeutic options available against Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic at this time, the evaluation of… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- SivoMixx (200 billion), Azithromycin and hydroxychloroquine
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2020to 31 Jul 2020
- Phase
- Observational
- 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
Study population: Symptomatic patients affected by COVID-19 admitted to Policlinico Umberto I, University of Rome "Sapienza" (Italy), between March 14, 2020 and April 4, 2020.
Who may be able to join
- COVID-19 diagnosis
- symptomatic COVID-19
- hospitalization in infectious diseases wards
Who cannot join
- Pregnant
- hospitalization in Intensive Care Unit
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Public Heath and Infectious Diseases. University of Rome "Sapienza" (Italy)
Rome, 00161
About this study
Official title: Evaluation of the Impact of Bacteriotherapy in the Treatment of COVID-19
In light of its high morbidity and mortality, COronaVIrus Disease 19 (COVID-19) pandemic spread is considered an unprecedented global health challenge.
Given the very limited therapeutic options available against Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic at this time, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research.
Read more
This is an observational, retrospective, non-profit study on the adjuvant use of bacteriotherapy in the early control of disease progression in patients affected by COVID-19 and treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases.
The main purpose of the study is to evaluate the effectiveness of bacteriotherapy in reducing the clinical impact of acute diarrhea, containing the progression of COVID-19 and preventing the need for hospitalization in intensive care units.
Read the detailed description
Italy was the first European country hit by the severe outbreak of the SARS-CoV-2 epidemic emerged from China, with a high morbidity and associated mortality.
Given the limited treatment options currently available, the search for resources capable of improving disease outcomes is fundamental for the management of patients
Systemic inflammation related to COVID-19, dietary changes, and use of antibiotics are all variables that contribute to changes in the gut microbiota with significant impact on the disease outcomes. Probiotic supplementation can help to correct these issues.
Moreover some strains of lactobacilli and bifidobacteria inhibit influenza virus, rhinovirus, respiratory syncytial virus, adenovirus, and pneumovirus .
- Being tested
- SivoMixx (200 billion), Azithromycin, hydroxychloroquine
- Keywords
- COVID-19 pneumonia, gut-lung axis, microbiome
- Medical subject headings
- Pneumonia, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SivoMixx (200 billion)Dietary supplement
Composition of SivoMixx: Streptococcus thermophilus DSM322245, Bifidobacterium lactis DSM 32246, Bifidobacterium lactis DSM 32247, Lactobacillus acidophilus DSM 32241, Lactobacillus helveticus DSM 32242, Lactobacillus paracasei DSM 32243, Lactobacillus plantarum DSM 32244, Lactobacillus brevis DSM 27961 (NB: DSM n°... : bacterial strain identification code)
AzithromycinDrug
dose: 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day)
dose: 200 mg, 1 cp x 2 / day
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Azithromycin 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day), plus hydroxychloroquine cp 200 mg, 1 cp x 2 / day. Receives: Drug: Azithromycin; Drug: hydroxychloroquine | |
| bacteriotherapy | Dietary Supplement: SivoMixx (200 billion) plus Azithromycin 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day), and hydroxychloroquine cp 200 mg, 1 cp x 2 / day. Receives: Dietary Supplement: SivoMixx (200 billion); Drug: Azithromycin; Drug: hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
delta of time of disappearance of acute diarrhea
Comparison between the two groups. Acute diarrhea was defined as a stool with increased water content, volume, or frequency that lasts less than 14 days.
Measured: 21 days
Secondary outcomes (3)
Delta in the number of patients requiring orotracheal intubation despite treatment
Comparison between the two groups
Measured: 21 days
Delta of crude mortality
Comparison between the two groups
Measured: 21 days
Delta of length of stay for patients in hospital
Comparison between the two groups
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Mar 2020
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giancarlo Ceccarelli, University of Roma La Sapienza
- Investigators
- Gabriella d'Ettorre, MD, PhD, Principal investigator, University of Rome Sapienza - Policlinico Umberto I Rome (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368351
- Sponsor's protocol ID
- DPHID-UniRoma05
- Acronym
- BACT-ovid
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patel R, DuPont HL. New approaches for bacteriotherapy: prebiotics, new-generation probiotics, and synbiotics. Clin Infect Dis. 2015 May 15;60 Suppl 2(Suppl 2):S108-21. doi: 10.1093/cid/civ177.
PubMed 25922396Jiang X, Hou X, Tang L, Jiang Y, Ma G, Li Y. A phase trial of the oral Lactobacillus casei vaccine polarizes Th2 cell immunity against transmissible gastroenteritis coronavirus infection. Appl Microbiol Biotechnol. 2016 Sep;100(17):7457-69. doi: 10.1007/s00253-016-7424-9. Epub 2016 Mar 28.
PubMed 27020282Jayawardena R, Sooriyaarachchi P, Chourdakis M, Jeewandara C, Ranasinghe P. Enhancing immunity in viral infections, with special emphasis on COVID-19: A review. Diabetes Metab Syndr. 2020 Jul-Aug;14(4):367-382. doi: 10.1016/j.dsx.2020.04.015. Epub 2020 Apr 16.
PubMed 32334392
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Bacteriotherapy in the Treatment of COVID-19
- ClinicalTrials.gov ID
- NCT04368351
- Acronym / sponsor ID
- BACT-ovid / DPHID-UniRoma05
- Keywords
- COVID-19 pneumonia, gut-lung axis, microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 29 Apr 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.
In light of its high morbidity and mortality, COronaVIrus Disease 19 (COVID-19) pandemic spread is considered an unprecedented global health challenge.
Given the very limited therapeutic options available against Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic at this time, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research.
This is an observational, retrospective, non-profit study on the adjuvant use of bacteriotherapy in the early control of disease progression in patients affected by COVID-19 and treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases.
The main purpose of the study is to evaluate the effectiveness of bacteriotherapy in reducing the clinical impact of acute diarrhea, containing the progression of COVID-19 and preventing the need for hospitalization in intensive care units.
Detailed description
Italy was the first European country hit by the severe outbreak of the SARS-CoV-2 epidemic emerged from China, with a high morbidity and associated mortality.
Given the limited treatment options currently available, the search for resources capable of improving disease outcomes is fundamental for the management of patients
Systemic inflammation related to COVID-19, dietary changes, and use of antibiotics are all variables that contribute to changes in the gut microbiota with significant impact on the disease outcomes. Probiotic supplementation can help to correct these issues.
Moreover some strains of lactobacilli and bifidobacteria inhibit influenza virus, rhinovirus, respiratory syncytial virus, adenovirus, and pneumovirus .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | – | Drug: Azithromycin, Drug: hydroxychloroquineAzithromycin 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day), plus hydroxychloroquine cp 200 mg, 1 cp x 2 / day. |
| bacteriotherapy | – | Dietary Supplement: SivoMixx (200 billion), Drug: Azithromycin, Drug: hydroxychloroquineDietary Supplement: SivoMixx (200 billion) plus Azithromycin 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day), and hydroxychloroquine cp 200 mg, 1 cp x 2 / day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic patients affected by COVID-19 admitted to Policlinico Umberto I, University of Rome "Sapienza" (Italy), between March 14, 2020 and April 4, 2020.
Key inclusion criteria (3 listed)
- COVID-19 diagnosis
- symptomatic COVID-19
- hospitalization in infectious diseases wards
Key exclusion criteria (2 listed)
- Pregnant
- hospitalization in Intensive Care Unit
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 |
|---|---|---|
| SivoMixx (200 billion)Composition of SivoMixx: Streptococcus thermophilus DSM322245, Bifidobacterium lactis DSM 32246, Bifidobacterium lactis DSM 32247, Lactobacillus acidophilus DSM 32241, Lactobacillus helveticus DSM 32242, Lactobacillus paracasei DSM 32243, Lactobacillus plantarum DSM 32244, Lactobacillus brevis DSM 27961 (NB: DSM n°... : bacterial strain identification code) | Dietary supplement | bacteriotherapy |
| Azithromycindose: 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day) | Drug | Standard of care, bacteriotherapy |
| hydroxychloroquinedose: 200 mg, 1 cp x 2 / day | Drug | Standard of care, bacteriotherapy |
Primary outcome
delta of time of disappearance of acute diarrhea
Time frame: 21 days
Comparison between the two groups. Acute diarrhea was defined as a stool with increased water content, volume, or frequency that lasts less than 14 days.
3 secondary outcomes
Delta in the number of patients requiring orotracheal intubation despite treatment
Time frame: 21 days
Delta of crude mortality
Time frame: 21 days
Delta of length of stay for patients in hospital
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Results publication: PubMed 25922396Patel R, DuPont HL. New approaches for bacteriotherapy: prebiotics, new-generation probiotics, and synbiotics. Clin Infect Dis. 2015 May 15;60 Suppl 2(Suppl 2):S108-21. doi: 10.1093/cid/civ177.
- Results publication: PubMed 27020282Jiang X, Hou X, Tang L, Jiang Y, Ma G, Li Y. A phase trial of the oral Lactobacillus casei vaccine polarizes Th2 cell immunity against transmissible gastroenteritis coronavirus infection. Appl Microbiol Biotechnol. 2016 Sep;100(17):7457-69. doi: 10.1007/s00253-016-7424-9. Epub 2016 Mar 28.
- Results publication: PubMed 32334392Jayawardena R, Sooriyaarachchi P, Chourdakis M, Jeewandara C, Ranasinghe P. Enhancing immunity in viral infections, with special emphasis on COVID-19: A review. Diabetes Metab Syndr. 2020 Jul-Aug;14(4):367-382. doi: 10.1016/j.dsx.2020.04.015. Epub 2020 Apr 16.
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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.
Gabriella d'Ettorre, MD, PhD principal investigator
University of Rome Sapienza - Policlinico Umberto I Rome (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Pneumonia, run by University of Roma La Sapienza at 1 site in Italy.
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 3 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: status not confirmed, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
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?
delta of time of disappearance of acute diarrhea (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04368351, which also lists 3 linked publications.
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 4 May 2020.