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Based on feedback from our study participants on the taste, spray optimization is necessary
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum Microbiome spray group | Active Comparator | Daily use of microbiome spray for two weeks |
|
| Placebo spray group | Placebo Comparator | Daily use of placebo spray for two weeks |
|
| Household member group | No Intervention | No use of spray |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microbiome spray | Biological | Throat spray containing 3 beneficial lactobacilli strains |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veronique Verhoeven | Antwerp | 2020 | Belgium |
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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
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Double blind, randomized, placebo controlled
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| Placebo spray | Biological | Throat spray |
|
| 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 |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |