Microbiome Therapy in Covid-19 Primary Care Support

University Hospital, Antwerp150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

150

Conditions

SARS-CoV Infection Corona Virus Infection

Interventions

Microbiome sprayBIOLOGICAL

Throat spray containing 3 beneficial lactobacilli strains

Placebo sprayBIOLOGICAL

Throat spray

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Veronique Verhoeven

Antwerp, Belgium

Outcomes

Primary Outcomes

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.

Time frame: 3 weeks

Secondary Outcomes

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.

Time frame: 3 weeks

Change in absolute numbers of SARS-CoV-2 after using microbiome spray

Quantification via qPCR

Time frame: 3 weeks

Change in absolute numbers of specific bacterial pathogens after using microbiome spray

Quantification via qPCR

Time frame: 3 weeks

Change in microbiome of nose/throat region after using microbiome spray.

Time frame: 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

Time frame: 3 weeks

Prevalence of COVID-19 in the index patients' household members

Data from ClinicalTrials.gov

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