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Efficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adults

Information source: Afexa Life Sciences Inc
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Upper Respiratory Infection

Intervention: CVT-E002 (Cold-FX); a natural health product (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: CV Technologies

Official(s) and/or principal investigator(s):
Gerry Predy, MD, Principal Investigator, Affiliation: Capital Health, Canada

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.

Clinical Details

Official title: Efficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adult Employees in Continuing Care Facilities

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

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

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

Detailed description: Eligible continuing care employees will be randomly assigned to either the treatment or placebo group with equal numbers in each group. The treatment will consist of taking two capsules of CVT-E002 (400mg)or placebo every morning, after breakfast, for a period of 12 weeks. The subjects will be given an assessment form to log specific symptoms on a daily basis if they get a cold. Symptoms include sore throat, runny nose, nasal congestion, hoarseness, cough, earaches, and fever. Subjects will be required to maintain the same dosing even during an upper respiratory infection and will be requested not to take any additional medication for their upper respiratory infection unless prescribed by their family physicians.

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- age 18-64 years

- not pregnant or breast feeding

- good general health

Exclusion Criteria:

- 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

Locations and Contacts

The Capital Care Group Continuing Care facilities, Edmonton, Alberta T5K 2J8, Canada
Additional Information

Starting date: December 2005
Last updated: June 4, 2009

Page last updated: August 20, 2015

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