Context: Since the discovery of toll-like receptor 3 (TLR3), no specific tools have been developed\nto modulate its activity in upper respiratory tract viral infections (URTIs). Contafluââ??¢ (antibodies\nto TLR3 cytoplasmic fragment) is the first specific TLR3 modulator that showed efficacy in a mouse\nmodel of influenza. Objective: To evaluate the efficacy of Contaflu in URTI. Methods: A doubleblind\nrandomized placebo-controlled trial in adults with self-reported URTI (the ESTUAR trial)\nwas conducted in 2012/2013 in Belgium. Adult outpatients started a 7-day treatment course with\noral tablets of Contaflu or placebo within 36 h after onset of at least one of 4 typical symptoms of\nURTI. Patients were examined twice by their general practitioners, on days 2-3 and 10-14 after\nstart of treatment. The primary endpoint was the overall severity of URTI calculated as the sum of\nWisconsin Upper Respiratory Symptom Survey (WURSS-21) scores over the follow-up. Independent\nStudentââ?¬â?¢s t test was used to compare the disease severity between groups. Results: A total of\n243 patients were enrolled by 32 investigators (121 Contaflu, 122 placebo); 92% of cases matched\nICD codes J00 or J06. Most patients had very mild (41.8%) or mild (18.2%) URTI symptoms. In the\nITT cohort, neither primary nor secondary outcome measures (duration of URTI, day-to-day and\noverall functional impairments) showed statistically significant differences between groups. The\nrate of adverse events was similar in both groups. In patients with moderate to severe URTI\nsymptoms, Contaflu tended to reduce the overall disease severity, daily symptoms, and to improve\nthe functional state. Due to the small size of the corresponding subgroups, Contaflu efficacy on\ndaily scores was statistically significant (p < 0.05) only 1, 2, and 5 days after start of treatment.\nConclusion: Contaflu was ineffective in mild URTI and showed efficacy in moderate to severe URTI\ncases.
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