tetano
Editor, Senior Moderator
BMC Infect Dis
. 2021 Jul 2;21(1):635.
doi: 10.1186/s12879-021-06348-5.
Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial
Julio Vallejos[SUP] 1 [/SUP], Rodrigo Zoni[SUP] 2 [/SUP], María Bangher[SUP] 1 [/SUP], Silvina Villamandos[SUP] 1 [/SUP], Angelina Bobadilla[SUP] 3 [/SUP], Fabian Plano[SUP] 4 [/SUP], Claudia Campias[SUP] 3 [/SUP], Evangelina Chaparro Campias[SUP] 5 [/SUP], Maria Fernanda Medina[SUP] 1 [/SUP], Fernando Achinelli[SUP] 4 [/SUP], Hector Andres Guglielmone[SUP] 5 [/SUP], Jorge Ojeda[SUP] 4 [/SUP], Diego Farizano Salazar[SUP] 4 [/SUP], Gerardo Andino[SUP] 5 [/SUP], Pablo Kawerin[SUP] 5 [/SUP], Silvana Dellamea[SUP] 4 [/SUP], Antonia Cristina Aquino[SUP] 4 [/SUP], Victor Flores[SUP] 4 [/SUP], Carolina N Martemucci[SUP] 5 [/SUP], Silvina Maria Martinez[SUP] 5 [/SUP], Juan Emanuel Segovia[SUP] 3 [/SUP], Paola Itati Reynoso[SUP] 1 [/SUP], Noelia Carolina Sosa[SUP] 1 [/SUP], Mariana Elizabeth Robledo[SUP] 1 [/SUP], Joaquina Maria Guarrochena, Maria Mercedes Vernengo[SUP] 3 [/SUP], Natalia Ruiz Diaz[SUP] 5 [/SUP], Elba Meza[SUP] 3 [/SUP], María Gabriela Aguirre[SUP] 1 [/SUP]
Affiliations
Abstract
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: To determine whether ivermectin treatment can prevent hospitalization in individuals with early COVID-19.
Design, setting and participants: 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: 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: 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: 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: Low percentage of hospitalization events, dose of ivermectin and not including only high-risk population.
Conclusion: 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: ClinicalTrials.gov NCT04529525 .
. 2021 Jul 2;21(1):635.
doi: 10.1186/s12879-021-06348-5.
Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial
Julio Vallejos[SUP] 1 [/SUP], Rodrigo Zoni[SUP] 2 [/SUP], María Bangher[SUP] 1 [/SUP], Silvina Villamandos[SUP] 1 [/SUP], Angelina Bobadilla[SUP] 3 [/SUP], Fabian Plano[SUP] 4 [/SUP], Claudia Campias[SUP] 3 [/SUP], Evangelina Chaparro Campias[SUP] 5 [/SUP], Maria Fernanda Medina[SUP] 1 [/SUP], Fernando Achinelli[SUP] 4 [/SUP], Hector Andres Guglielmone[SUP] 5 [/SUP], Jorge Ojeda[SUP] 4 [/SUP], Diego Farizano Salazar[SUP] 4 [/SUP], Gerardo Andino[SUP] 5 [/SUP], Pablo Kawerin[SUP] 5 [/SUP], Silvana Dellamea[SUP] 4 [/SUP], Antonia Cristina Aquino[SUP] 4 [/SUP], Victor Flores[SUP] 4 [/SUP], Carolina N Martemucci[SUP] 5 [/SUP], Silvina Maria Martinez[SUP] 5 [/SUP], Juan Emanuel Segovia[SUP] 3 [/SUP], Paola Itati Reynoso[SUP] 1 [/SUP], Noelia Carolina Sosa[SUP] 1 [/SUP], Mariana Elizabeth Robledo[SUP] 1 [/SUP], Joaquina Maria Guarrochena, Maria Mercedes Vernengo[SUP] 3 [/SUP], Natalia Ruiz Diaz[SUP] 5 [/SUP], Elba Meza[SUP] 3 [/SUP], María Gabriela Aguirre[SUP] 1 [/SUP]
Affiliations
- PMID: 34215210
- DOI: 10.1186/s12879-021-06348-5
Abstract
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: To determine whether ivermectin treatment can prevent hospitalization in individuals with early COVID-19.
Design, setting and participants: 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: 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: 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: 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: Low percentage of hospitalization events, dose of ivermectin and not including only high-risk population.
Conclusion: 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: ClinicalTrials.gov NCT04529525 .