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 .

Active, not recruiting
COVID
Pneumonia
Diarrhea

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)
bacteriotherapy

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)
Standard of care
bacteriotherapy

Drug: hydroxychloroquine
dose: 200 mg, 1 cp x 2 / day
Standard of care
bacteriotherapy

Eligibility Criteria

Inclusion Criteria:

- COVID-19 diagnosis

- symptomatic COVID-19

- hospitalization in infectious diseases wards

Exclusion Criteria:

- Pregnant

- hospitalization in Intensive Care Unit

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
Italy

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

University of Roma La Sapienza
NCT Number
Keywords
COVID‐19 pneumonia
gut-lung axis
Microbiome
MeSH Terms
Pneumonia
Diarrhea
Azithromycin
Hydroxychloroquine