Microbiome Therapy in Covid-19 Primary Care Support (MiCel)

Antwerp University Hospital (UZA)

Status: Suspended

Conditions: Corona Virus Infection; SARS-CoV Infection

Treatments: Biological: Placebo spray; Biological: Microbiome spray

Study type: Interventional

Funder types: Other

Identifiers

NCT04793997

B3002021000018

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups, including a placebo group

Verum Microbiome spray group

Active Comparator group

Description:

Daily use of microbiome spray for two weeks

Treatment:

Biological: Microbiome spray

Placebo spray group

Placebo Comparator group

Description:

Daily use of placebo spray for two weeks

Treatment:

Biological: Placebo spray

Household member group

No Intervention group

Description:

No use of spray