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Placebo-controlled randomized trials testing CVT-E002/COLD-fX for ability to prevent acute respiratory infection (ARI) |
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Author/Year |
Subject |
Design |
Duration |
Dosage |
Results/Conclusion |
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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). |
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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). |
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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). |
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