PMID- 34820034
OWN - NLM
STAT- MEDLINE
DCOM- 20220117
LR  - 20220117
IS  - 1916-7245 (Electronic)
IS  - 1198-2241 (Print)
IS  - 1198-2241 (Linking)
VI  - 2021
DP  - 2021
TI  - Efficacy and Safety of Ergoferon in Children from 6 Months to 6 Years Old with 
      Acute Respiratory Viral Infections in Contemporary Outpatient Practice: A 
      Multicenter, Double-Blind, Placebo-Controlled Randomized Trial.
PG  - 5570178
LID - 10.1155/2021/5570178 [doi]
LID - 5570178
AB  - To evaluate the efficacy and safety of Ergoferon in combination with symptomatic 
      therapy in children from 6 months to 6 years old with acute respiratory 
      infections (ARI) in contemporary outpatient practice, an international, 
      multicenter, double-blind, placebo-controlled, randomized, parallel-group 
      clinical trial was performed. Derived by technological treatment of antibodies to 
      interferon gamma, histamine, and CD4, Ergoferon was previously proved to modulate 
      its molecular targets promoting effective antiviral protection. The data of 282 
      patients with oral temperature >/=38.0 degrees C plus mild to moderate severity of flu-like 
      nonspecific and nasal/throat/chest symptoms were included in intention-to-treat 
      analysis (n = 140, Ergoferon group; n = 142, placebo group). Time to alleviation 
      of all ARI symptoms was the primary endpoint, and 8 outcome measures were 
      estimated as the secondary endpoints. Respiratory viruses were confirmed in 57.1% 
      (Ergoferon) and 54.9% (Placebo) of patients. Compared to placebo, Ergoferon 
      reduced time to alleviation of all ARI symptoms (4.5 +/- 1.7 versus 5.2 +/- 2.2 days 
      in placebo; p=0.026) including fever (2.8 +/- 1.5 vs 3.4 +/- 2.0; p=0.031), flu-like 
      nonspecific (4.0 +/- 1.8 vs 4.7 +/- 2.2, p=0.022), and nasal/throat/chest (4.3 +/- 2.0 
      versus 5.0 +/- 2.3; p=0.024) symptoms. Ergoferon add-on therapy decreased the mean 
      total symptom severity score (according to 4-point scale for each symptom), ARI 
      severity, frequency of antipyretic use, and percentage of complication requiring 
      antibiotics and increased the percentage of recovered patients. The incidence of 
      adverse events (AEs) in the Ergoferon group was significantly lower compared to 
      the placebo group (7.0% versus 18.8%; p=0.004) including infectious diseases 
      (3.5% vs 12.5%; p=0.008). In the Ergoferon group, AEs were mild or moderate. In 8 
      (57.1%) cases, AEs were unrelated to Ergoferon, in 5 (35.7%), the relationship 
      was uncertain, and in 1 (7.1%), it was possible (mild rash on the face). 
      Ergoferon treatment is beneficial for infants and young children with ARI in 
      contemporary outpatient practice. Being well-tolerated, Ergoferon increases the 
      symptomatic therapy effectiveness and improves the patient condition and disease 
      outcomes.
CI  - Copyright (c) 2021 N. A. Geppe et al.
FAU - Geppe, N A
AU  - Geppe NA
AUID- ORCID: 0000-0003-0547-3686
AD  - Department of Childhood Diseases, Sechenov First Moscow State Medical University, 
      Moscow 119435, Russia.
FAU - Blokhin, B M
AU  - Blokhin BM
AD  - Department of Polyclinic and Emergency Pediatrics, Pirogov Russian National 
      Research Medical University, Moscow 117997, Russia.
AD  - Children's Medical Center, Main Medical Department of the Presidential 
      Administration of the Russian Federation, Moscow 109012, Russia.
FAU - Shamsheva, O V
AU  - Shamsheva OV
AD  - Children's Medical Center, Main Medical Department of the Presidential 
      Administration of the Russian Federation, Moscow 109012, Russia.
FAU - Abdrakhmanova, S T
AU  - Abdrakhmanova ST
AD  - Department of Childhood Diseases No. 3, Astana Medical University, Astana 010000, 
      Kazakhstan.
FAU - Alikhanova, K A
AU  - Alikhanova KA
AD  - Department of General Medical Practice No. 3, Karaganda Medical University, 
      Karaganda 100008, Kazakhstan.
FAU - Myrzabekova, G T
AU  - Myrzabekova GT
AD  - Department of Pediatrics, Kazakh Medical University of Continuing Education, 
      Almaty 050040, Kazakhstan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20211115
PL  - Egypt
TA  - Can Respir J
JT  - Canadian respiratory journal
JID - 9433332
RN  - 0 (Antibodies)
RN  - 0 (ergoferon)
SB  - IM
MH  - Antibodies
MH  - Child
MH  - Child, Preschool
MH  - Double-Blind Method
MH  - Humans
MH  - Infant
MH  - Outpatients
MH  - *Respiratory Tract Infections/drug therapy
MH  - SARS-CoV-2
MH  - Treatment Outcome
MH  - *Virus Diseases
PMC - PMC8608533
COIS- Geppe N.A., Blokhin B.M., Shamsheva O.V., Abdrakhmanova S.T., Alikhanova K.A., 
      and Myrzabekova G.T. received a research grant for this RCT from OOO "NPF 
      "MATERIA MEDICA HOLDING." Geppe N.A. received the grant from OOO "NPF "MATERIA 
      MEDICA HOLDING" to coach investigators for this RCT.
EDAT- 2021/11/26 06:00
MHDA- 2022/01/18 06:00
PMCR- 2021/11/15
CRDT- 2021/11/25 06:35
PHST- 2021/02/25 00:00 [received]
PHST- 2021/08/30 00:00 [revised]
PHST- 2021/09/30 00:00 [accepted]
PHST- 2021/11/25 06:35 [entrez]
PHST- 2021/11/26 06:00 [pubmed]
PHST- 2022/01/18 06:00 [medline]
PHST- 2021/11/15 00:00 [pmc-release]
AID - 10.1155/2021/5570178 [doi]
PST - epublish
SO  - Can Respir J. 2021 Nov 15;2021:5570178. doi: 10.1155/2021/5570178. eCollection 
      2021.