Bacteriotherapy in the Treatment of COVID-19

NCT04368351 | Unknown

• 1 other identifier: DPHID-UniRoma05
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Pneumonia; Diarrhea

Keywords

COVID-19 pneumonia; gut-lung axis; microbiome

Outcome Measures

Primary Outcomes (1)

• delta of time of disappearance of acute diarrhea

  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.

  21 days

Secondary Outcomes (3)

• Delta in the number of patients requiring orotracheal intubation despite treatment

  21 days

• Delta of crude mortality

  21 days

• Delta of length of stay for patients in hospital

  21 days

Study Arms (2)

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; 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.

Dietary Supplement: SivoMixx (200 billion); Drug: Azithromycin; Drug: hydroxychloroquine

Interventions

SivoMixx (200 billion) DIETARY_SUPPLEMENT

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

Azithromycin DRUG

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

hydroxychloroquine DRUG

dose: 200 mg, 1 cp x 2 / day

Standard of care; bacteriotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnant
• hospitalization in Intensive Care Unit

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of Public Heath and Infectious Diseases. University of Rome "Sapienza" (Italy)

Rome, 00161, Italy

Location

Related Publications (3)

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

  PMID: 25922396 RESULT

• 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.

  PMID: 27020282 RESULT

• 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 Jul-Aug;14(4):367-382. doi: 10.1016/j.dsx.2020.04.015. Epub 2020 Apr 16.

  PMID: 32334392 RESULT

MeSH Terms

Conditions

Pneumonia; Diarrhea

Interventions

Azithromycin; Hydroxychloroquine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gabriella d'Ettorre, MD, PhD

  University of Rome Sapienza - Policlinico Umberto I Rome (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, MSc

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: March 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: July 31, 2020
• Last Updated: May 4, 2020

Record last verified: 2020-04

Locations

IT (1)