NCT04458519

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

July 16, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2021

Completed
Last Updated

June 1, 2021

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

July 1, 2020

Last Update Submit

May 27, 2021

Conditions

COVID-19 Infection

Keywords

COVID-19Nasal irrigationProbioticMicrobiomeLactococcus lactis W136

Outcome Measures

Primary Outcomes (1)

  • Change in severity of COVID-19 infection

    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.

    4 weeks

Secondary Outcomes (3)

  • Number of days with any symptom of anosmia

    4 weeks

  • Maximal intensity attained in overall assessment of symptoms of COVID-19 infection as measured on Visual Analogue Scale (VAS).

    4 weeks

  • Number of days where rescue medication is required

    4 weeks

Study Arms (2)

Probiorinse

EXPERIMENTAL

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

Saline solution

ACTIVE COMPARATOR

Nasal irrigations with saline (NeilMed Sinus Rinse, (NPN: 80027142)) twice-daily for a period of fourteen days

Other: Saline solution

Interventions

ProbiorinseOTHER

Nasal irrigations with probiotic twice-daily for a period of fourteen days

Also known as: Natural health products, Probiotic
Probiorinse
Saline solutionOTHER

Nasal irrigations with saline-only twice-daily for a period of fourteen days

Also known as: Natural health product
Saline solution

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 1P1, Canada

Location

Related Publications (4)

  • Liu J, Li S, Liu J, Liang B, Wang X, Wang H, Li W, Tong Q, Yi J, Zhao L, Xiong L, Guo C, Tian J, Luo J, Yao J, Pang R, Shen H, Peng C, Liu T, Zhang Q, Wu J, Xu L, Lu S, Wang B, Weng Z, Han C, Zhu H, Zhou R, Zhou H, Chen X, Ye P, Zhu B, Wang L, Zhou W, He S, He Y, Jie S, Wei P, Zhang J, Lu Y, Wang W, Zhang L, Li L, Zhou F, Wang J, Dittmer U, Lu M, Hu Y, Yang D, Zheng X. Longitudinal characteristics of lymphocyte responses and cytokine profiles in the peripheral blood of SARS-CoV-2 infected patients. EBioMedicine. 2020 May;55:102763. doi: 10.1016/j.ebiom.2020.102763. Epub 2020 Apr 18.

    PMID: 32361250BACKGROUND

  • Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

    PMID: 32192578BACKGROUND

  • Liu Y, Yan LM, Wan L, Xiang TX, Le A, Liu JM, Peiris M, Poon LLM, Zhang W. Viral dynamics in mild and severe cases of COVID-19. Lancet Infect Dis. 2020 Jun;20(6):656-657. doi: 10.1016/S1473-3099(20)30232-2. Epub 2020 Mar 19. No abstract available.

    PMID: 32199493BACKGROUND

  • Shen Z, Xiao Y, Kang L, Ma W, Shi L, Zhang L, Zhou Z, Yang J, Zhong J, Yang D, Guo L, Zhang G, Li H, Xu Y, Chen M, Gao Z, Wang J, Ren L, Li M. Genomic Diversity of Severe Acute Respiratory Syndrome-Coronavirus 2 in Patients With Coronavirus Disease 2019. Clin Infect Dis. 2020 Jul 28;71(15):713-720. doi: 10.1093/cid/ciaa203.

    PMID: 32129843BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

ProbioticsSaline Solution

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Martin Y Desrosiers, MD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-blinded, randomized, prospective trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 7, 2020

Study Start

July 16, 2020

Primary Completion

May 27, 2021

Study Completion

May 27, 2021

Last Updated

June 1, 2021

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)