Bacteriotherapy in the Treatment of COVID-19

• Conditions: Diarrhea; COVID; Pneumonia
• Interventions: Dietary Supplement: SivoMixx (200 billion); Drug: hydroxychloroquine; Drug: Azithromycin

• Registration Number: NCT04368351
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-03-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-29
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-05-04
• Primary Completion: 2020-06-30
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

• Pregnant
• hospitalization in Intensive Care Unit

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bacteriotherapy	SivoMixx (200 billion)	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.
Standard of care	hydroxychloroquine	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.
bacteriotherapy	Azithromycin	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.
Standard of care	Azithromycin	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.
bacteriotherapy	hydroxychloroquine	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.

Primary Outcome Measures

Name	Time	Method
delta of time of disappearance of acute diarrhea	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

Name	Time	Method
Delta in the number of patients requiring orotracheal intubation despite treatment	21 days	Comparison between the two groups
Delta of crude mortality	21 days	Comparison between the two groups
Delta of length of stay for patients in hospital	21 days	Comparison between the two groups

Trial Locations

Locations (1)

Department of Public Heath and Infectious Diseases. University of Rome "Sapienza" (Italy); 🇮🇹 Rome, Italy