Overview

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

Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
CV Technologies
Collaborator:
Capital Health, Canada
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