PMID- 35273939
OWN - NLM
STAT- MEDLINE
DCOM- 20220315
LR  - 20221207
IS  - 2296-2565 (Electronic)
IS  - 2296-2565 (Linking)
VI  - 10
DP  - 2022
TI  - Safety and Efficacy of a MEURI Program for the Use of High Dose Ivermectin in 
      COVID-19 Patients.
PG  - 813378
LID - 10.3389/fpubh.2022.813378 [doi]
LID - 813378
AB  - BACKGROUND: In the absence of antiviral alternatives, interventions under 
      research for COVID-19 might be offered following guidelines from WHO for 
      monitored emergency use of unregistered and experimental interventions (MEURI). 
      Ivermectin is among several drugs explored for its role against SARS-CoV-2, with 
      a well-known safety profile but conflicting data regarding clinical utility for 
      COVID-19. The aim of this report is to inform on the results of a MEURI Program 
      of high-dose ivermectin in COVID-19 carried out by the Ministry of Health of the 
      Province of La Pampa, Argentina. METHODS: COVID-19 subjects, within 5 days of 
      symptoms onset were invited to participate in the program, which consisted in the 
      administration of ivermectin 0.6 mg/kg/day for 5 days plus standard of care. 
      Active pharmacosurveillance was performed for 21 days, and hepatic laboratory 
      assessments were performed in a subset of patients. Frequency of Intensive Care 
      Unit (ICU) admission and COVID-19-related mortality of subjects in the ivermectin 
      intention to treat group were compared with that observed in inhabitants of the 
      same province during the same period not participating in the program. RESULTS: 
      From 21,232 subjects with COVID-19, 3,266 were offered and agreed to participate 
      in the ivermectin program and 17,966 did not and were considered as controls. A 
      total of 567 participants reported 819 adverse events (AEs); 3.13% discontinued 
      ivermectin due to adverse events. ICU admission was significantly lower in the 
      ivermectin group compared to controls among participants >/=40 year-old (1.2 vs. 
      2.0%, odds ratio 0.608; p = 0.024). Similarly, mortality was lower in the 
      ivermectin group in the full group analysis (1.5 vs. 2.1%, odds ratio 0.720; p = 
      0.029), as well as in subjects >/= 40 year- old (2.7 vs. 4.1%, odds ratio 0.655; p 
      = 0.005). CONCLUSIONS: This report highlights the safety and possible efficacy of 
      high dose ivermectin as a potentially useful intervention deserving public 
      health-based consideration for COVID-19 patients.
CI  - Copyright (c) 2022 Mayer, Krolewiecki, Ferrero, Bocchio, Barbero, Miguel, Paladini, 
      Delgado, Ojeda, Elorza, Bertone, Fleitas, Vera and Kohan.
FAU - Mayer, Marcos Alejandro
AU  - Mayer MA
AD  - Ministerio de Salud de la Provincia de La Pampa, Santa Rosa, Argentina.
AD  - Fundacion Centro de Salud e Investigaciones Medicas, Santa Rosa, Argentina.
AD  - Consejo Nacional de Investigaciones Cientificas y Tecnicas, Buenos Aires, 
      Argentina.
FAU - Krolewiecki, Alejandro
AU  - Krolewiecki A
AD  - Consejo Nacional de Investigaciones Cientificas y Tecnicas, Buenos Aires, 
      Argentina.
AD  - Instituto de Investigaciones de Enfermedades Tropicales, Universidad Nacional de 
      Salta, Sede Regional Oran, Salta, Argentina.
FAU - Ferrero, Alejandro
AU  - Ferrero A
AD  - Ministerio de Salud de la Provincia de La Pampa, Santa Rosa, Argentina.
FAU - Bocchio, Marcelo
AU  - Bocchio M
AD  - Ministerio de Salud de la Provincia de La Pampa, Santa Rosa, Argentina.
FAU - Barbero, Juan
AU  - Barbero J
AD  - Ministerio de Salud de la Provincia de La Pampa, Santa Rosa, Argentina.
FAU - Miguel, Marcos
AU  - Miguel M
AD  - Ministerio de Salud de la Provincia de La Pampa, Santa Rosa, Argentina.
FAU - Paladini, Ariel
AU  - Paladini A
AD  - Ministerio de Salud de la Provincia de La Pampa, Santa Rosa, Argentina.
FAU - Delgado, Carlos
AU  - Delgado C
AD  - Ministerio de Salud de la Provincia de La Pampa, Santa Rosa, Argentina.
FAU - Ojeda, Juan Ramon
AU  - Ojeda JR
AD  - Ministerio de Salud de la Provincia de La Pampa, Santa Rosa, Argentina.
FAU - Elorza, Claudia
AU  - Elorza C
AD  - Ministerio de Salud de la Provincia de La Pampa, Santa Rosa, Argentina.
FAU - Bertone, Ana
AU  - Bertone A
AD  - Ministerio de Salud de la Provincia de La Pampa, Santa Rosa, Argentina.
FAU - Fleitas, Pedro Emanuel
AU  - Fleitas PE
AD  - Consejo Nacional de Investigaciones Cientificas y Tecnicas, Buenos Aires, 
      Argentina.
AD  - Instituto de Investigaciones de Enfermedades Tropicales, Universidad Nacional de 
      Salta, Sede Regional Oran, Salta, Argentina.
FAU - Vera, Gustavo
AU  - Vera G
AD  - Ministerio de Salud de la Provincia de La Pampa, Santa Rosa, Argentina.
FAU - Kohan, Mario Ruben
AU  - Kohan MR
AD  - Ministerio de Salud de la Provincia de La Pampa, Santa Rosa, Argentina.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220222
PL  - Switzerland
TA  - Front Public Health
JT  - Frontiers in public health
JID - 101616579
RN  - 70288-86-7 (Ivermectin)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Ivermectin/therapeutic use
MH  - SARS-CoV-2
MH  - *COVID-19 Drug Treatment
PMC - PMC8902036
OTO - NOTNLM
OT  - COVID-19
OT  - ICU-admission
OT  - ivermectin
OT  - mortality
OT  - safety
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/03/12 06:00
MHDA- 2022/03/16 06:00
PMCR- 2022/02/22
CRDT- 2022/03/11 05:40
PHST- 2021/11/11 00:00 [received]
PHST- 2022/01/31 00:00 [accepted]
PHST- 2022/03/11 05:40 [entrez]
PHST- 2022/03/12 06:00 [pubmed]
PHST- 2022/03/16 06:00 [medline]
PHST- 2022/02/22 00:00 [pmc-release]
AID - 10.3389/fpubh.2022.813378 [doi]
PST - epublish
SO  - Front Public Health. 2022 Feb 22;10:813378. doi: 10.3389/fpubh.2022.813378. 
      eCollection 2022.