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Efficacy of Intranasal Probiotic Treatment to Reduce Severity of Symptoms in COVID19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04458519
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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 14 days, followed by a 14 day observation period. Irrigation will be performed with either Probiorinse probiotic nasal irrigation solution or NeilMed Sinus rinse. Patients will be able to identify their treatments, but study staff will be blinded as to assignment.

Condition or disease Intervention/treatment Phase
COVID-19 Infection Other: Probiorinse Other: Saline solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-blinded, randomized, prospective trial
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description:

Investigator responsible for product allocation and blinding is not in contact with study participant and will only be made aware of the process of their evolution in case of emergency.

Study personel in daily contact with the patient are unaware of the patient treatment assignement and are thus blinded.

Primary Purpose: Treatment
Official Title: Randomised Single Blinded Clinical Study of Efficacy of Intranasal Probiotic Treatment to Reduce Severity of Symptoms in COVID19 Infection
Actual Study Start Date : July 16, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Probiorinse
Nasal irrigations with Probiorinse (2.4 Billion CFU (Colony-Forming Units) of Lactococcus Lactis W136, (NPN: 80085895)) twice-daily for a period of fourteen days
Other: Probiorinse
Nasal irrigations with probiotic twice-daily for a period of fourteen days
Other Names:
  • Natural health products
  • Probiotic

Active Comparator: Saline solution
Nasal irrigations with saline (NeilMed Sinus Rinse, (NPN: 80027142)) twice-daily for a period of fourteen days
Other: Saline solution
Nasal irrigations with saline-only twice-daily for a period of fourteen days
Other Name: Natural health product




Primary Outcome Measures :
  1. Change in severity of COVID-19 infection [ Time Frame: 4 weeks ]
    Change in severity of COVID-19 infection as assessed by number of days with any symptoms of COVID-19 infection greater than or equal to 35 as measured on VAS scale as assessed at the 28 day endpoint.


Secondary Outcome Measures :
  1. Number of days with any symptom of anosmia [ Time Frame: 4 weeks ]
    Number of days with any symptom of anosmia

  2. Maximal intensity attained in overall assessment of symptoms of COVID-19 infection as measured on Visual Analogue Scale (VAS). [ Time Frame: 4 weeks ]
    Maximal intensity attained in overall assessment of symptoms of COVID-19 infection as measured on Visual Analogue Scale (VAS). VAS scale from 0 to 100, with a higher score indicating a worse outcome.

  3. Number of days where rescue medication is required [ Time Frame: 4 weeks ]
    Number of days where rescue medication is required



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458519


Contacts
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Contact: Martin Y Desrosiers, MD 514-890-8000 ext 14170 desrosiers_martin@hotmail.com
Contact: Leandra Mfuna Endam, MSc 438-378-3343 leandra.mfuna-endam.chum@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM) Recruiting
Montreal, Quebec, Canada, H2X 1P1
Contact: Leandra Mfuna Endam, MSc    514-890-8000 ext 13278    leandra.mfuna-endam.chum@ssss.gouv.qc.ca   
Contact: Martin Y Desrosiers, MD    514-890-8000 ext 14170    desrosiers_martin@hotmail.com   
Principal Investigator: Martin Y Desrosiers, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Martin Y Desrosiers, MD Centre hospitalier de l'Université de Montréal (CHUM)
Publications:
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04458519    
Other Study ID Numbers: PROBCO
249512 ( Other Identifier: Health Canada )
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
COVID-19
Nasal irrigation
Probiotic
Microbiome
Lactococcus lactis W136
Additional relevant MeSH terms:
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Infection
Communicable Diseases