NCT04793997

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

February 28, 2021

Last Update Submit

May 31, 2021

Conditions

SARS-CoV InfectionCorona Virus Infection

Keywords

lactobacilliProbioticsThroat spray

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in duration of COVID-19 infection symptoms after using microbiome spray

    3 weeks

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

    3 weeks

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

    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

    3 weeks

  • +1 more secondary outcomes

Study Arms (3)

Verum Microbiome spray group

ACTIVE COMPARATOR

Daily use of microbiome spray for two weeks

Biological: Microbiome spray

Placebo spray group

PLACEBO COMPARATOR

Daily use of placebo spray for two weeks

Biological: Placebo spray

Household member group

NO INTERVENTION

No use of spray

Interventions

Microbiome sprayBIOLOGICAL

Throat spray containing 3 beneficial lactobacilli strains

Verum Microbiome spray group
Placebo sprayBIOLOGICAL

Throat spray

Placebo spray group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veronique Verhoeven

Antwerp, 2020, Belgium

Location

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCoronavirus Infections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double blind, randomized, placebo controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.ir.

Study Record Dates

First Submitted

February 28, 2021

First Posted

March 11, 2021

Study Start

February 1, 2021

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

June 3, 2021

Record last verified: 2021-05

Locations

BE(1)