Microbiome Therapy in Covid-19 Primary Care Support

Not Applicable

Suspended

• Conditions: SARS-CoV Infection; Corona Virus Infection
• Interventions: Biological: Microbiome spray; Biological: Placebo spray

• Registration Number: NCT04793997
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-28
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-11
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-31
• Last Update Posted: 2021-06-03
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum Microbiome spray group	Microbiome spray	Daily use of microbiome spray for two weeks
Placebo spray group	Placebo spray	Daily use of placebo spray for two weeks

Primary Outcome Measures

Name	Time	Method
Change in severity of COVID-19 infection symptoms after using microbiome spray	3 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in microbiome of nose/throat region after using microbiome spray.	3 weeks
Change in duration of COVID-19 infection symptoms after using microbiome spray	3 weeks	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.
Change in absolute numbers of SARS-CoV-2 after using microbiome spray	3 weeks	Quantification via qPCR
Change in absolute numbers of specific bacterial pathogens after using microbiome spray	3 weeks	Quantification via qPCR
Prevalence of antibodies against SARS-CoV-2 in the index patients' household members	3 weeks	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
Prevalence of COVID-19 in the index patients' household members	3 weeks	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.

Trial Locations

Locations (1)

Veronique Verhoeven; 🇧🇪 Antwerp, Belgium