SARS-CoV Infection, Corona Virus Infection
Conditions
Keywords
lactobacilli, Probiotics, Throat spray
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.
Interventions
BIOLOGICALMicrobiome spray
Throat spray containing 3 beneficial lactobacilli strains
BIOLOGICALPlacebo spray
Throat spray
Sponsors
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Double blind, randomized, placebo controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| Change in microbiome of nose/throat region after using microbiome spray. | 3 weeks | — |
Countries
Belgium
Outcome results
None listed