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Research Article
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- This study involved human subjects.
- The author confirmed that all appropriate ethical guidelines for the use of human subjects have been followed, any necessary IRB and/or ethics committee review has been obtained, and information about the IRB/ethics committee is included in the manuscript.
- The author has confirmed that all necessary patient/participant consent or assent has been obtained and the appropriate institutional forms have been archived. If the IRB/ethics committee waived the requirement for patient/participant consent or assent, an explanation for the waiver is included in the text.
- This study reports on a clinical trial.
- The author has confirmed that this trial has been registered with an ICMJE-approved registry, and the trial registration ID has been provided in the text. If the article reports on a study that was registered retrospectively, a statement explaining why the study was not registered in advance has been provided in the text.
- The author has confirmed that a statement listing potential conflicts of interest or lack thereof is included in the text.
Ivermectin inhibits the replication of SARS-CoV-2 in vitro at concentrations not readily achievable with currently approved doses. There is limited evidence to support its clinical use in COVID-19 patients. We conducted a Pilot, randomized, double-blind, placebo-controlled trial to determine the efficacy of a single dose of ivermectin to reduce the proportion of PCR positives, viral load at day 7 post treatment.
Consecutive patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and mild COVID-19 (no pneumonia) and no risk factors for complicated disease attending the emergency room of the Clínica Universidad de Navarra. Patients were randomized 1:1 to receive ivermectin, 400 mcg/kg, single dose (n = 12) or placebo (n = 12).
The primary outcome measure was the proportion of patients with detectable SARS-CoV-2 RNA by PCR from nasopharyngeal swab at day 7 post-treatment. The primary outcome was supported by determination of the viral load and infectivity of each sample. The differences between ivermectin and placebo were calculated using Fisher’s exact test and presented as a relative risk ratio.
All patients recruited completed the trial (median age, 26 [range, 18-54] years; 12 [50%] women; 100% had symptoms at recruitment, 70% reported headache, 62% reported fever, 50% reported general malaise and 25% reported cough). At day 7, there was no difference in the proportion of PCR positive patients (RR 0.92, 95% CI: 0.77-1.09, p = 1.0). The ivermectin group had lower median viral loads at days 4 and 7 post treatment as well as lower median IgG titers at day 21 post treatment. Hyposmia/anosmia (76 vs 158 patient-days) and cough (68 vs 97 patient-days) were less frequent in the ivermectin group.
Among patients with mild COVID-19 and no risk factors for severe disease receiving a single 400 mcg/kg dose of ivermectin within 48 hours of fever or cough onset there was no difference in the proportion of PCR positives. There was however a marked reduction of anosmia/hyposmia, a reduction of cough and a tendency to lower viral loads and lower IgG titers which warrants assessment in larger trials.
Trial registration ClinicalTrials.gov Identifier: NCT04390022 https://clinicaltrials.gov/ct2/show/NCT04390022
Keywords
COVID-19, ivermectin, randomized control trial
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This is a list of supplementary files associated with this preprint. Click to download.
- 20201126CONSORTChecklist.pdf
CONSORT Checklist
- 20201126Supplementarymaterial.docx
Supplementary figures and tables
- SAINTSAPv1.0.pdf
Statistical analysis plan
- SAINTprotocolv2.0Clean.pdf
Protocol
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This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Research Article
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
View the published article at EClinicalMedicine.
Version 1
Posted 07 Dec, 2020
Community comments: 2
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Infectious Diseases
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Declarations:
Declarations
- This study involved human subjects.
- The author confirmed that all appropriate ethical guidelines for the use of human subjects have been followed, any necessary IRB and/or ethics committee review has been obtained, and information about the IRB/ethics committee is included in the manuscript.
- The author has confirmed that all necessary patient/participant consent or assent has been obtained and the appropriate institutional forms have been archived. If the IRB/ethics committee waived the requirement for patient/participant consent or assent, an explanation for the waiver is included in the text.
- This study reports on a clinical trial.
- The author has confirmed that this trial has been registered with an ICMJE-approved registry, and the trial registration ID has been provided in the text. If the article reports on a study that was registered retrospectively, a statement explaining why the study was not registered in advance has been provided in the text.
- The author has confirmed that a statement listing potential conflicts of interest or lack thereof is included in the text.
View the published article at EClinicalMedicine.
Ivermectin inhibits the replication of SARS-CoV-2 in vitro at concentrations not readily achievable with currently approved doses. There is limited evidence to support its clinical use in COVID-19 patients. We conducted a Pilot, randomized, double-blind, placebo-controlled trial to determine the efficacy of a single dose of ivermectin to reduce the proportion of PCR positives, viral load at day 7 post treatment.
Consecutive patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and mild COVID-19 (no pneumonia) and no risk factors for complicated disease attending the emergency room of the Clínica Universidad de Navarra. Patients were randomized 1:1 to receive ivermectin, 400 mcg/kg, single dose (n = 12) or placebo (n = 12).
The primary outcome measure was the proportion of patients with detectable SARS-CoV-2 RNA by PCR from nasopharyngeal swab at day 7 post-treatment. The primary outcome was supported by determination of the viral load and infectivity of each sample. The differences between ivermectin and placebo were calculated using Fisher’s exact test and presented as a relative risk ratio.
All patients recruited completed the trial (median age, 26 [range, 18-54] years; 12 [50%] women; 100% had symptoms at recruitment, 70% reported headache, 62% reported fever, 50% reported general malaise and 25% reported cough). At day 7, there was no difference in the proportion of PCR positive patients (RR 0.92, 95% CI: 0.77-1.09, p = 1.0). The ivermectin group had lower median viral loads at days 4 and 7 post treatment as well as lower median IgG titers at day 21 post treatment. Hyposmia/anosmia (76 vs 158 patient-days) and cough (68 vs 97 patient-days) were less frequent in the ivermectin group.
Among patients with mild COVID-19 and no risk factors for severe disease receiving a single 400 mcg/kg dose of ivermectin within 48 hours of fever or cough onset there was no difference in the proportion of PCR positives. There was however a marked reduction of anosmia/hyposmia, a reduction of cough and a tendency to lower viral loads and lower IgG titers which warrants assessment in larger trials.
Trial registration ClinicalTrials.gov Identifier: NCT04390022 https://clinicaltrials.gov/ct2/show/NCT04390022
Figure 1
Figure 2
Figure 3
Figure 4
This is a list of supplementary files associated with this preprint. Click to download.
- 20201126CONSORTChecklist.pdf
CONSORT Checklist
- 20201126Supplementarymaterial.docx
Supplementary figures and tables
- SAINTSAPv1.0.pdf
Statistical analysis plan
- SAINTprotocolv2.0Clean.pdf
Protocol
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