Status:
COMPLETED
Efficacy of Intranasal Probiotic Treatment to Reduce Severity of Symptoms in COVID19 Infection
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
COVID-19 Infection
Eligibility:
All Genders
18-59 years
Phase:
NA
Brief Summary
Randomised, single-blinded trial. Patients with a diagnosis of COVID-19 infection within the past 96 hours and not requiring hospitalization will be recruited into a trial of BID Nasal irrigation for ...
Detailed Description
BACKGROUND/OBJECTIVE The potential role of the microbiome in COVID-19 disease remains little explored, yert may offer an unique therapeutic opportunity for its treatment. Airway inflammation and micr...
Eligibility Criteria
Inclusion
- Males and females aged 18-59 years
- Positive diagnosis of COVID-19 infection less than 96 hours
- Characteristic respiratory symptoms present but no more than mild to moderate
- No need for oxygen
- Temperature less than 38.0 ºC
- Not presently being considered for hospitalisation or ICU admission
- Able to perform nasal irrigation
- Able to provide consent
- Able to communicate with the study team by phone, text or email
Exclusion
- Patients with pre-existing conditions or demographic features placing them at increased risk of complications from COVID10 infection will not be included in this study. These will be considered exclusion factors, thus individuals will be questioned as to the presence or these factors during their telephone screening.
- Respiratory disorders:
- Asthma, Pre-existing COPD, bronchiectasis or cystic fibrosis
- Hypertension
- Cardiovascular disease:
- Rhythm disturbances, recent (less than 6 months), angina pectoris cardiac insufficiency
- Diabetes
- Immunosuppressed patients (other than COVID-19 induced)
- Primary immune deficiencies such as hypogammaglobulinemia or common variable immune deficiency (CVID)
- Chemotherapy depressing the immune system
- Immune suppressing medications such as prednisone, Imuran, or TNF inhibitors, or anti-rejection transplant drugs.
- Solid organ transplant
- Cancer under treatment or within five years (except basocellular skin cancers)
- Pregnant or breastfeeding women or women unwilling to practice contraception as outlined in the study protocol for the duration of the study period.
- Allergy to milk or its derivatives
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04458519
Start Date
July 16 2020
End Date
May 27 2021
Last Update
June 1 2021
Active Locations (1)
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1
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 1P1