NCT00259831

Brief Summary

The purpose of the Study is to determine the prophylactic effects of CVT-E002 treatment for upper respiratory tract infections in healthy adult employees working with residents in continuing care facilities. It is hypothesized that the use of CVT-E002 will effectively reduce the incidence, severity and duration of upper respiratory infections among the participants when compared to placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_3

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

June 8, 2009

Status Verified

June 1, 2009

Enrollment Period

6 months

First QC Date

November 29, 2005

Last Update Submit

June 4, 2009

Conditions

Upper Respiratory Infection

Keywords

coldinfluenza

Outcome Measures

Primary Outcomes (1)

  • To determine the efficacy of CVT-E002 in reducing the number of upper respiratory infections during the study.

Secondary Outcomes (1)

  • To test if the prophylactic management with CVT-E002 decreases the severity and duration of symptoms related to an upper respiratory tract infection.

Interventions

CVT-E002 (Cold-FX); a natural health productDRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-64 years
  • not pregnant or breast feeding
  • good general health

You may not qualify if:

  • medical conditions: HIV infection; malignancy; cardiovascular disease; hypertension; renal, pulmonary or hepatic abnormalities; neurologic or psychiatric disease; tuberculosis; multiple sclerosis; recent acute respiratory infection (\<2 weeks)
  • medications: warfarin; immunosuppressive therapy; corticosteroids; phenalzine; pentobarbital; haloperidol
  • major surgical procedure in the previous six months
  • history of alcohol/drug abuse
  • pregnancy and lactation in women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Capital Care Group Continuing Care facilities

Edmonton, Alberta, T5K 2J8, Canada

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsCommon ColdInfluenza, Human

Interventions

COLD-fX

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesOrthomyxoviridae Infections

Study Officials

  • Gerry Predy, MD

    Capital Health, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

December 1, 2005

Primary Completion

June 1, 2006

Study Completion

August 1, 2006

Last Updated

June 8, 2009

Record last verified: 2009-06

Locations

CA(1)