TITLE:
Efficacy of a Novel Antibody TLR3 Modulator in the Self-Treatment of Common Cold: The ESTUAR Trial
AUTHORS:
Andrey Martyushev-Poklad, Jacques Bruhwyler, Stéphane Heijmans, Michel Thiry
KEYWORDS:
Common Cold, Treatment, Toll-Like Receptor 3, TLR3 Modulation, Randomized Clinical Trial
JOURNAL NAME:
Advances in Infectious Diseases,
Vol.5 No.4,
December
25,
2015
ABSTRACT: Context: Since the
discovery of toll-like receptor 3 (TLR3), no specific tools have been developed
to modulate its activity in upper respiratory tract viral infections (URTIs).
ContafluTM (antibodies to TLR3
cytoplasmic fragment) is the first specific TLR3 modulator that showed efficacy
in a mouse model of influenza.
Objective: To evaluate the efficacy of Contaflu in URTI. Methods: A double-blind
randomized placebo-controlled trial in adults with self-reported URTI (the
ESTUAR trial) was conducted in 2012/2013 in Belgium. Adult outpatients started
a 7-day treatment course with oral tablets of Contaflu or placebo within 36 h
after onset of at least one of 4 typical symptoms of URTI. Patients were
examined twice by their general practitioners, on days 2-3 and 10-14 after
start of treatment. The primary endpoint was the overall severity of URTI
calculated as the sum of Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
scores over the follow-up. Independent Student’s t test was used to compare the
disease severity between groups. Results: A total of 243 patients were enrolled
by 32 investigators (121 Contaflu, 122 placebo); 92% of cases matched ICD codes
J00 or J06. Most patients had very mild (41.8%) or mild (18.2%) URTI symptoms.
In the ITT cohort, neither primary nor secondary outcome measures (duration of
URTI, day-to-day and overall functional impairments) showed statistically
significant differences between groups. The rate of adverse events was similar
in both groups. In patients with moderate to severe URTI symptoms, Contaflu
tended to reduce the overall disease severity, daily symptoms, and to improve
the functional state. Due to the small size of the corresponding subgroups,
Contaflu efficacy on daily scores was statistically significant (p