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Table 1: Published Clinical Studies on CVT-E002/COLD-fX®

Placebo-controlled randomized trials testing CVT-E002/COLD-fX for ability to prevent acute respiratory infection (ARI)

 

Author/Year

Subject

Design

Duration

Dosage

Results/Conclusion

McElhaney et al, 200614

ARI prevention

R, DB, PC

n = 43 healthy adults 65 years and older. All subjects received influenza vaccine at week 4 of study.

4 months

400 mg once daily

Secondary analysis of data found that 62% of placebo group reported symptoms, compared with 32% in CVT-E002 group during the last 8 weeks of the study (p < 0.05). During the same time period, duration of ARI-related symptoms was 55% shorter in CVT-E002 group than placebo group (5.6 days vs. 12.6 days, p = 0.04).

McElhaney et al, 200415

ARI prevention

R, DB, PC

Elderly nursing home patients – average age of 81 for the first treatment period (n = 89) and 83.5 years for the second (n = 109). 74% were women and 90% had received influenza vaccine.

78 subjects completed first study & 103 completed second study.

2 study periods:

(A) 8 weeks (2000)

(B) 12 weeks (2001)

200 mg 2x daily

Overall no statistically significant differences between 2 groups in self-reported ARI symptoms. However, influenza culture (a secondary endpoint analysis) revealed 7 laboratory and symptom confirmed cases of influenza in placebo group vs. only 1 case in CVT-E002 group (p = 0.03). Laboratory and symptom confirmed ARI due to RSV was also lower in CVT-E002 group compared to placebo (p = 0.009).

Predy et al, 200516

ARI prevention

R, DB, PC

n = 323 adults ages 18–65 years

(n =279 started included in final analyses)

4 months

400 mg once daily

Mean number of colds per person was 0.68 in the CVT-E002 group and 0.93 in the placebo group (p = 0.017). Number of people with ≥ 2 colds was 34 (23%) in the placebo group, and 13 (10%) in the CVT-E002 group (p = 0.004). For those with colds, the average duration was 16.5 days in the placebo group and 10.8 days in the CVT-E002 group (p < 0.001). The average total symptom score was 112.3 in the placebo group and 77.5 in the CVT-E002 group (p = 0.002).