NCT05043376

Brief Summary

This is a randomised, open-label and controlled clinical trial aimed to investigate the adjuvant treatment benefits of probiotic Streptococcus salivarius K12 in hospitalised mild-to-moderate patients with COVID-19 disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable covid19

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

Study Start

First participant enrolled

September 10, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 11, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2021

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

September 11, 2021

Last Update Submit

January 22, 2022

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Recovery and live discharge

    Number of patients with clinical improvement

    From day 1 to day 14

Secondary Outcomes (3)

  • Hospitalisation days

    From day 1 to day 14

  • Effect on inflammatory markers

    From day 1 to day 14

  • ICU transfer

    From day 1 to day 14

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

In this arm patients will receive the standard COVID-19 care as per the hospital guidelines.

Drug: Standard of care

BLIS K12

EXPERIMENTAL

In this arm patients will receive the BLIS K12 as add-on to the standard COVID-19 care

Drug: Standard of careDietary Supplement: BLIS K12

Interventions

Standard of careDRUG

Standard COVID-19 care as per the hospital guidelines

BLIS K12Standard of care
BLIS K12DIETARY_SUPPLEMENT

Daily 2 oral BLIS K12 tablets for up to 14 days.

BLIS K12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years (both sexes)
  • Hospitalized confirmed (RT-PCR) COVID-19 patients (not already in ICU) admitted for treatment of COVID-19 and not receiving mechanical ventilatory support
  • Patients who have signed informed consent

You may not qualify if:

  • Patients with proven hypersensitivity or allergic reaction to the tested formula
  • Patients who decline to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Edward Medical University Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

September 11, 2021

First Posted

September 14, 2021

Study Start

September 10, 2021

Primary Completion

November 21, 2021

Study Completion

November 21, 2021

Last Updated

February 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)