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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

Tracking Information
First Submitted Date April 27, 2020
First Posted Date April 29, 2020
Last Update Posted Date May 4, 2020
Actual Study Start Date March 1, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 27, 2020)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 27, 2020)
  • Delta in the number of patients requiring orotracheal intubation despite treatment [ Time Frame: 21 days ]
    Comparison between the two groups
  • Delta of crude mortality [ Time Frame: 21 days ]
    Comparison between the two groups
  • Delta of length of stay for patients in hospital [ Time Frame: 21 days ]
    Comparison between the two groups
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bacteriotherapy in the Treatment of COVID-19
Official Title Evaluation of the Impact of Bacteriotherapy in the Treatment of COVID-19
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.

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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • COVID
  • Pneumonia
  • Diarrhea
Intervention
  • 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
Study Groups/Cohorts
  • 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.
    Interventions:
    • 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.
    Interventions:
    • Dietary Supplement: SivoMixx (200 billion)
    • Drug: Azithromycin
    • Drug: hydroxychloroquine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 27, 2020)
70
Original Actual Enrollment Same as current
Estimated Study Completion Date July 31, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant
  • hospitalization in Intensive Care Unit
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04368351
Other Study ID Numbers DPHID-UniRoma05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Giancarlo Ceccarelli, University of Roma La Sapienza
Study Sponsor University of Roma La Sapienza
Collaborators Not Provided
Investigators
Principal Investigator: Gabriella d'Ettorre, MD, PhD University of Rome Sapienza - Policlinico Umberto I Rome (Italy)
PRS Account University of Roma La Sapienza
Verification Date April 2020