Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial.
Journal
BMC infectious diseases
ISSN: 1471-2334
Titre abrégé: BMC Infect Dis
Pays: England
ID NLM: 100968551
Informations de publication
Date de publication:
02 Jul 2021
02 Jul 2021
Historique:
received:
06
05
2021
accepted:
17
06
2021
entrez:
3
7
2021
pubmed:
4
7
2021
medline:
8
7
2021
Statut:
epublish
Résumé
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) has changed our lives. The scientific community has been investigating re-purposed treatments to prevent disease progression in coronavirus disease (COVID-19) patients. To determine whether ivermectin treatment can prevent hospitalization in individuals with early COVID-19. A randomized, double-blind, placebo-controlled study was conducted in non-hospitalized individuals with COVID-19 in Corrientes, Argentina. Patients with SARS-CoV-2 positive nasal swabs were contacted within 48 h by telephone to invite them to participate. The trial randomized 501 patients between August 19th 2020 and February 22nd 2021. Patients were randomized to ivermectin (N = 250) or placebo (N = 251) arms in a staggered dose, according to the patient's weight, for 2 days. The efficacy of ivermectin to prevent hospitalizations was evaluated as primary outcome. We evaluated secondary outcomes in relationship to safety and other efficacy end points. The mean age was 42 years (SD ± 15.5) and the median time since symptom onset to the inclusion was 4 days [interquartile range 3-6]. The primary outcome of hospitalization was met in 14/250 (5.6%) individuals in ivermectin group and 21/251 (8.4%) in placebo group (odds ratio 0.65; 95% confidence interval, 0.32-1.31; p = 0.227). Time to hospitalization was not statistically different between groups. The mean time from study enrollment to invasive mechanical ventilatory support (MVS) was 5.25 days (SD ± 1.71) in ivermectin group and 10 days (SD ± 2) in placebo group, (p = 0.019). There were no statistically significant differences in the other secondary outcomes including polymerase chain reaction test negativity and safety outcomes. Low percentage of hospitalization events, dose of ivermectin and not including only high-risk population. Ivermectin had no significant effect on preventing hospitalization of patients with COVID-19. Patients who received ivermectin required invasive MVS earlier in their treatment. No significant differences were observed in any of the other secondary outcomes. ClinicalTrials.gov NCT04529525 .
Sections du résumé
BACKGROUND
BACKGROUND
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) has changed our lives. The scientific community has been investigating re-purposed treatments to prevent disease progression in coronavirus disease (COVID-19) patients.
OBJECTIVE
OBJECTIVE
To determine whether ivermectin treatment can prevent hospitalization in individuals with early COVID-19.
DESIGN, SETTING AND PARTICIPANTS
METHODS
A randomized, double-blind, placebo-controlled study was conducted in non-hospitalized individuals with COVID-19 in Corrientes, Argentina. Patients with SARS-CoV-2 positive nasal swabs were contacted within 48 h by telephone to invite them to participate. The trial randomized 501 patients between August 19th 2020 and February 22nd 2021.
INTERVENTION
METHODS
Patients were randomized to ivermectin (N = 250) or placebo (N = 251) arms in a staggered dose, according to the patient's weight, for 2 days.
MAIN OUTCOMES AND MEASURES
METHODS
The efficacy of ivermectin to prevent hospitalizations was evaluated as primary outcome. We evaluated secondary outcomes in relationship to safety and other efficacy end points.
RESULTS
RESULTS
The mean age was 42 years (SD ± 15.5) and the median time since symptom onset to the inclusion was 4 days [interquartile range 3-6]. The primary outcome of hospitalization was met in 14/250 (5.6%) individuals in ivermectin group and 21/251 (8.4%) in placebo group (odds ratio 0.65; 95% confidence interval, 0.32-1.31; p = 0.227). Time to hospitalization was not statistically different between groups. The mean time from study enrollment to invasive mechanical ventilatory support (MVS) was 5.25 days (SD ± 1.71) in ivermectin group and 10 days (SD ± 2) in placebo group, (p = 0.019). There were no statistically significant differences in the other secondary outcomes including polymerase chain reaction test negativity and safety outcomes.
LIMITATIONS
CONCLUSIONS
Low percentage of hospitalization events, dose of ivermectin and not including only high-risk population.
CONCLUSION
CONCLUSIONS
Ivermectin had no significant effect on preventing hospitalization of patients with COVID-19. Patients who received ivermectin required invasive MVS earlier in their treatment. No significant differences were observed in any of the other secondary outcomes.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT04529525 .
Identifiants
pubmed: 34215210
doi: 10.1186/s12879-021-06348-5
pii: 10.1186/s12879-021-06348-5
pmc: PMC8250562
doi:
Substances chimiques
Antiviral Agents
0
Placebos
0
Ivermectin
70288-86-7
Banques de données
ClinicalTrials.gov
['NCT04529525']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
635Références
N Engl J Med. 2021 Feb 25;384(8):693-704
pubmed: 32678530
Nature. 2020 Oct;586(7830):481-482
pubmed: 33077974
Lancet. 2020 Mar 28;395(10229):1054-1062
pubmed: 32171076
J Pharm Pharm Sci. 2020;23:462-469
pubmed: 33227231
J Antimicrob Chemother. 2020 Apr 1;75(4):827-834
pubmed: 31960060
Arch Bronconeumol (Engl Ed). 2020 Dec;56(12):828-830
pubmed: 33994641
QJM. 2021 Feb 18;:
pubmed: 33599247
N Engl J Med. 2021 Feb 18;384(7):610-618
pubmed: 33406353
Intern Emerg Med. 2021 Mar;16(2):281-308
pubmed: 33398609
Antiviral Res. 2013 Sep;99(3):301-6
pubmed: 23769930
Contemp Clin Trials. 2021 Feb;101:106272
pubmed: 33422642
Biochem J. 2012 May 1;443(3):851-6
pubmed: 22417684
EClinicalMedicine. 2021 Feb;32:100720
pubmed: 33495752
Int J Infect Dis. 2021 Feb;103:214-216
pubmed: 33278625
Antiviral Res. 2020 Jun;178:104787
pubmed: 32251768
JAMA. 2021 Apr 13;325(14):1426-1435
pubmed: 33662102
Lancet. 2020 Feb 15;395(10223):497-506
pubmed: 31986264
PLoS One. 2020 Nov 11;15(11):e0242184
pubmed: 33175880
J Int Med Res. 2021 May;49(5):3000605211013550
pubmed: 33983065
J Microbiol Immunol Infect. 2020 Jun;53(3):404-412
pubmed: 32173241
Trials. 2020 Nov 24;21(1):965
pubmed: 33234158
N Engl J Med. 2020 Nov 5;383(19):1813-1826
pubmed: 32445440
N Engl J Med. 2021 Feb 18;384(7):619-629
pubmed: 33232588
N Engl J Med. 2021 Jan 7;384(1):20-30
pubmed: 33332779
Sci Rep. 2016 Mar 18;6:23138
pubmed: 26988202