Microbiome Therapy in Covid-19 Primary Care Support

Study Overview
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Brief Summary
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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.

Official Title
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Covid-19 Primary Care Support With Microbiome Therapy.

Conditions
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SARS-CoV Infection, Corona Virus Infection

Intervention / Treatment
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* Biological: Microbiome spray
* Biological: Placebo spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind, randomized, placebo controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Verum Microbiome spray group<br>Daily use of microbiome spray for two weeks | Biological: Microbiome spray<br>* Throat spray containing 3 beneficial lactobacilli strains<br>|
| Placebo Comparator: Placebo spray group<br>Daily use of placebo spray for two weeks | Biological: Placebo spray<br>* Throat spray<br>|
| No Intervention: Household member group<br>No use of spray | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lactobacilli, Probiotics, Throat spray