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

• ClinicalTrials.gov Identifier: NCT04368351
• Recruitment Status: Active, not recruiting
• First Posted: April 29, 2020
• Last Update Posted: May 4, 2020
• Sponsor: University of Roma La Sapienza
• Information provided by (Responsible Party): Giancarlo Ceccarelli, University of Roma La Sapienza

Study Description

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 .

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Gabriella d'Ettorre, MD, PhD; University of Rome Sapienza - Policlinico Umberto I Rome (Italy)

More Information

Publications of Results:

Xu K, Cai H, Shen Y, Ni Q, Chen Y, Hu S, Li J, Wang H, Yu L, Huang H, Qiu Y, Wei G, Fang Q, Zhou J, Sheng J, Liang T, Li L. [Management of corona virus disease-19 (COVID-19): the Zhejiang experience]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020 Feb 21;49(1):0. Chinese.

Patel R, DuPont HL. New approaches for bacteriotherapy: prebiotics, new-generation probiotics, and synbiotics. Clin Infect Dis. 2015 May 15;60 Suppl 2:S108-21. doi: 10.1093/cid/civ177. Review.

Jiang 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.

Jayawardena 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 Apr 16;14(4):367-382. doi: 10.1016/j.dsx.2020.04.015. [Epub ahead of print]

• 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
• Last Update Posted: May 4, 2020
• Last Verified: April 2020

• 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:

Pneumonia; Diarrhea; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Azithromycin; Hydroxychloroquine; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents