Microbiome Therapy in Covid-19 Primary Care Support

Corona Virus Infection Clinical Trial

— MiCel  

Official title:

Covid-19 Primary Care Support With Microbiome Therapy.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04793997
• Other study ID #: B3002021000018
• Status: Suspended
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: May 2021
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 150
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• Infection
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Biological:
• Microbiome spray
Throat spray containing 3 beneficial lactobacilli strains
• Placebo spray
Throat spray

Locations

Country	Name	City	State
Belgium	Veronique Verhoeven	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in absolute numbers of SARS-CoV-2 after using microbiome spray	Quantification via qPCR	3 weeks
Secondary	Change in absolute numbers of specific bacterial pathogens after using microbiome spray	Quantification via qPCR	3 weeks
Secondary	Change in microbiome of nose/throat region after using microbiome spray.		3 weeks
Secondary	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
Secondary	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