Microbiome Therapy in Covid-19 Primary Care Support (MiCel)

Covid-19 Primary Care Support With Microbiome Therapy.

This double-blind, randomized, placebo-controlled study aims to investigate whether a throat spray containing probiotic bacteria (i.e. microbiome spray) can reduce the symptoms and complaints of the SARS-CoV-2 virus in patients with mild to moderate symptoms. In addition, the aim is to investigate whether the microbiome spray can prevent transmission of the SARS-CoV-2 virus to household members.

Study Overview

• Status: Suspended
• Conditions: Corona Virus Infection; SARS-CoV Infection
• Intervention / Treatment: Biological: Microbiome spray; Biological: Placebo spray

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2020
    • Veronique Verhoeven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients in primary care with a positive SARS-CoV-2 test based on PCR
• Instructed during screening and agreed not to use other probiotic nutritional supplements outside of the study during the study period
• Sign the consent form

Exclusion Criteria:

• Antibiotic use at baseline and during the study
• Vaccinated against SARS-CoV-2 at start of the study (both for index patients and household members that participate)
• Pregnant women
• History of use of probiotic supplements in the past two weeks
• Current diagnosis of cancer or immunosuppressive therapy within the past 6 months
• Acute and chronic infectious and inflammatory upper airway diseases (eg acute / chronic rhinosinusitis)
• Clinically significant bleeding disorder
• Any other medical condition that, in the principal investigator's opinion, warrants exclusion from the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Verum Microbiome spray group; Daily use of microbiome spray for two weeks	Biological: Microbiome spray; Throat spray containing 3 beneficial lactobacilli strains
PLACEBO_COMPARATOR: Placebo spray group; Daily use of placebo spray for two weeks	Biological: Placebo spray; Throat spray
NO_INTERVENTION: Household member group; No use of spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in severity of COVID-19 infection symptoms after using microbiome spray	Change in severity of COVID-19 infection symptoms as assessed by a symptom score (min 0 - max 65) based on the presence and absence of fever and ten COVID-19 related symptoms and, if present, the four and five severity categories, respectively.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in duration of COVID-19 infection symptoms after using microbiome spray	Change in duration of COVID-19 infection symptoms as assessed by a symptom score (min 0 - max 65) based on the presence and absence of fever and ten COVID-19 related symptoms and, if present, the four and five severity categories, respectively.	3 weeks
Change in absolute numbers of SARS-CoV-2 after using microbiome spray	Quantification via qPCR	3 weeks
Change in absolute numbers of specific bacterial pathogens after using microbiome spray	Quantification via qPCR	3 weeks
Change in microbiome of nose/throat region after using microbiome spray.		3 weeks
Prevalence of antibodies against SARS-CoV-2 in the index patients' household members	The investigators will assess the prevalence of antibodies against SARS-CoV-2 in the index patients' household members based on the analysis of a capillary (fingerprick) blood sample stored on Whatman903 protein saver card	3 weeks
Prevalence of COVID-19 in the index patients' household members	The investigators will assess the prevalence of COVID-19 in the index patients' household members based on the presence of symptoms reported in a symptom diary.	3 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ANTICIPATED): February 1, 2022
• Study Completion (ANTICIPATED): February 1, 2022

Study Registration Dates

• First Submitted: February 28, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (ACTUAL): March 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Probiotics; lactobacilli; Throat spray
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Severe Acute Respiratory Syndrome; Coronavirus Infections; Infections; Communicable Diseases
• Other Study ID Numbers: B3002021000018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No