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Bacteriotherapy in the Treatment of COVID-19 (BACT-ovid)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368351
Recruitment Status : Active, not recruiting
First Posted : April 29, 2020
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Giancarlo Ceccarelli, University of Roma La Sapienza

Brief 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 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.


Condition or disease Intervention/treatment
COVID Pneumonia Diarrhea Dietary Supplement: SivoMixx (200 billion) Drug: Azithromycin Drug: hydroxychloroquine

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 .

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Evaluation of the Impact of Bacteriotherapy in the Treatment of COVID-19
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Group/Cohort Intervention/treatment
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.
Drug: Azithromycin
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)

Drug: hydroxychloroquine
dose: 200 mg, 1 cp x 2 / day

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.
Dietary Supplement: 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)

Drug: Azithromycin
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)

Drug: hydroxychloroquine
dose: 200 mg, 1 cp x 2 / day




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Delta in the number of patients requiring orotracheal intubation despite treatment [ Time Frame: 21 days ]
    Comparison between the two groups

  2. Delta of crude mortality [ Time Frame: 21 days ]
    Comparison between the two groups

  3. Delta of length of stay for patients in hospital [ Time Frame: 21 days ]
    Comparison between the two groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • COVID-19 diagnosis
  • symptomatic COVID-19
  • hospitalization in infectious diseases wards

Exclusion Criteria:

  • Pregnant
  • hospitalization in Intensive Care Unit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368351


Locations
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Italy
Department of Public Heath and Infectious Diseases. University of Rome "Sapienza" (Italy)
Rome, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Gabriella d'Ettorre, MD, PhD University of Rome Sapienza - Policlinico Umberto I Rome (Italy)
Publications of Results:
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Responsible Party: Giancarlo Ceccarelli, MD, PhD, MSc, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT04368351    
Other Study ID Numbers: DPHID-UniRoma05
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giancarlo Ceccarelli, University of Roma La Sapienza:
COVID-19 pneumonia
gut-lung axis
microbiome
Additional relevant MeSH terms:
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Pneumonia
Diarrhea
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms, Digestive
Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents