PMID- 37167165
OWN - NLM
STAT- MEDLINE
DCOM- 20230515
LR  - 20230515
IS  - 0040-3660 (Print)
IS  - 0040-3660 (Linking)
VI  - 94
IP  - 11
DP  - 2022 Dec 26
TI  - [Non-specific prevention of COVID-19 during vaccination against a new coronavirus 
      infection: results of a multicenter, double-blind, placebo-controlled, randomized 
      clinical trial].
PG  - 1268-1277
LID - 10.26442/00403660.2022.11.201980 [doi]
AB  - BACKGROUND: A multicenter, double-blind, placebo-controlled, randomized clinical 
      trial (RCT) of the phase III efficacy and safety of Ergoferon((R)) for the 
      non-specific prevention of COVID-19 during vaccination against a new coronavirus 
      infection was conducted (permission of the Ministry of Health of the Russian 
      Federation numero sign559 dated 22.09.2021; ClinicalTrials.gov Identifier: NCT05069649). 
      AIM: To evaluate the efficacy and safety of the use of Ergoferon for the 
      non-specific prevention of COVID-19 during vaccination against a new coronavirus 
      infection. MATERIALS AND METHODS: From October 2021 to April 2022, 1,057 patients 
      aged 18 to 92 years who received component I of the "Gam-COVID-Vac" vaccine were 
      included. After screening, 1,050 patients were randomized into 2 groups: 526 
      people received Ergoferon according to the prophylactic scheme - 1 tablet per 
      administration 2 times a day for 3 weeks, the drug is not allowed during the meal 
      and should be kept in the mouth without swallowing, until completely dissolved; 
      524 patients received a placebo according to the Ergoferon((R)) scheme. The total 
      duration of participation in the study was 5 weeks + 3 days. The primary endpoint 
      is the number of RT-PCR - confirmed cases of SARS-CoV-2 infection, regardless of 
      the presence of symptoms during participation in the study. An additional 
      criterion of effectiveness is the proportion of those hospitalized with COVID-19. 
      The safety assessment included consideration of the presence and nature of 
      adverse events (AEs), their severity, relationship with the drug intake, and 
      outcome. Statistical data processing was carried out using SAS 9.4 with the 
      calculation of the exact Fisher test, chi(2) test, Cochrane-Mantel-Hensel test, 
      Wilcoxon test and other parameters. RESULTS: The ITT (Intention-to-treat) and PP 
      [Per Protocol] efficacy analysis included data from 1,050 [970] patients: 526 
      [489] people - Ergoferon((R)) group and 524 [481] people - Placebo group. The 
      primary endpoint - the number of laboratory-confirmed cases of SARS-CoV-2 
      infections was 3 times less compared to placebo - 7 (1.43%) vs 22 (4.57%), 
      respectively (p=0.0046; [p=0.0041]). Taking Ergoferon((R)) reduces the risk of 
      SARS-CoV-2 infection by more than 3 times in vaccinated patients during 5 weeks 
      of the vaccination and post-vaccination periods (p=0.0046 [p=0.0041]). Of the 
      COVID-19 patients in the Ergoferon((R)) group (1.33%) nobody was hospitalized. 
      According to the Post hoc analysis, Ergoferon((R)) reduces the risk of COVID-19 
      disease by 4 times in the period between the components I and II of the 
      "Gam-COVID-Vac" vaccine (p=0.0066 [p=0.006]). The frequency of AEs in both groups 
      did not differ. There were no registered AEs associated with the drug with a 
      reliable degree. There was a high level of patient compliance and good 
      tolerability. CONCLUSION: Ergoferon is an effective and safe drug for the 
      prevention of COVID-19 in people vaccinated against a new coronavirus infection.
FAU - Avdeeva, M G
AU  - Avdeeva MG
AUID- ORCID: 0000-0002-4979-8768
AD  - Kuban State Medical University.
FAU - Belousova, O N
AU  - Belousova ON
AUID- ORCID: 0000-0001-6862-0829
AD  - Belgorod State National Research University.
FAU - Orlova, E A
AU  - Orlova EA
AUID- ORCID: 0000-0002-3902-2018
AD  - Penza State Institute for Postgraduate Medical Education - branch of the Russian 
      Medical Academy of Continuous Professional Education.
FAU - Khamitov, R F
AU  - Khamitov RF
AUID- ORCID: 0000-0001-8821-0421
AD  - Kazan State Medical University.
FAU - Shvarts, Y G
AU  - Shvarts YG
AUID- ORCID: 0000-0002-5205-7311
AD  - Razumovsky Saratov State Medical University.
FAU - Kravchenko, I E
AU  - Kravchenko IE
AUID- ORCID: 0000-0003-4408-7542
AD  - Kazan State Medical University.
LA  - rus
SI  - ClinicalTrials.gov/NCT05069649
PT  - Clinical Trial, Phase III
PT  - English Abstract
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20221226
PL  - Russia (Federation)
TA  - Ter Arkh
JT  - Terapevticheskii arkhiv
JID - 2984818R
RN  - 0 (Vaccines)
SB  - IM
MH  - Humans
MH  - *COVID-19/epidemiology/prevention & control
MH  - SARS-CoV-2
MH  - Vaccination
MH  - Double-Blind Method
MH  - Treatment Outcome
MH  - *Vaccines
OTO - NOTNLM
OT  - COVID-19
OT  - Ergoferon
OT  - efficacy
OT  - non-specific prevention
OT  - prevention
OT  - safety
OT  - vaccination
EDAT- 2023/05/11 19:13
MHDA- 2023/05/15 06:42
CRDT- 2023/05/11 13:14
PHST- 2022/12/26 00:00 [received]
PHST- 2022/12/26 00:00 [accepted]
PHST- 2023/05/15 06:42 [medline]
PHST- 2023/05/11 19:13 [pubmed]
PHST- 2023/05/11 13:14 [entrez]
AID - 10.26442/00403660.2022.11.201980 [doi]
PST - epublish
SO  - Ter Arkh. 2022 Dec 26;94(11):1268-1277. doi: 10.26442/00403660.2022.11.201980.