https://www.sciencedirect.com/science/article/pii/S2589537020304648

JavaScript is disabled on your browser. Please enable JavaScript to
use all the features on this page. [1611270155] Skip to main content
Skip to article
Elsevier logo

  * Journals & Books

  *  
  *  

RegisterSign in
Sign inRegister

  * Journals & Books

  * Help

 
Download PDFDownload
[                    ]Advanced
EClinicalMedicine

EClinicalMedicine

Available online 19 January 2021, 100720
In Press, Corrected ProofWhat are Corrected Proof articles?
Journal home page for EClinicalMedicine

Research Paper
The effect of early treatment with ivermectin on viral load, symptoms
and humoral response in patients with non-severe COVID-19: A pilot,
double-blind, placebo-controlled, randomized clinical trial

Author links open overlay panelCarlosChaccour^a^b^cAinaCasellas^a^d
AndresBlanco-Di Matteo^bInigoPineda^bAlejandroFernandez-Montero^b
PaulaRuiz-Castillo^aMary-AnnRichardson^aMarianoRodriguez-Mateos^b
CarlotaJordan-Iborra^bJoeBrew^eFranciscoCarmona-Torre^b^fMiriam
Giraldez^bEsterLaso^bJuan C.Gabaldon-Figueira^bCarlotaDobano^aGemma
Moncunill^a^gJose R.Yuste^bJose L.Del Pozo^b...MirianFernandez-Alonso^b
Show more
Share
Cite
https://doi.org/10.1016/j.eclinm.2020.100720Get rights and content
Under a Creative Commons license
open access

Abstract

Background

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 evaluate the efficacy of a single dose of
ivermectin reduce the transmission of SARS-CoV-2 when administered
early after disease onset.

Methods

Consecutive patients with non-severe COVID-19 and no risk factors for
complicated disease attending the emergency room of the Clinica
Universidad de Navarra between July 31, 2020 and September 11, 2020
were enrolled. All enrollments occurred within 72 h of onset of fever
or cough. 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. This study is registered at ClinicalTrials.gov:
NCT04390022.

Findings

All patients recruited completed the trial (median age, 26 [IQR 19-36
in the ivermectin and 21-44 in the controls] 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
non-statistically significant lower viral loads at day 4 (p = 0*24
for gene E; p = 0*18 for gene N) and day 7 (p = 0*16 for gene E; p =
 0*18 for gene N) post treatment as well as lower IgG titers at day
21 post treatment (p = 0*24). Patients in the ivermectin group
recovered earlier from hyposmia/anosmia (76 vs 158 patient-days; p <
0.001).

Interpretation

Among patients with non-severe COVID-19 and no risk factors for
severe disease receiving a single 400 mcg/kg dose of ivermectin
within 72 h of fever or cough onset there was no difference in the
proportion of PCR positives. There was however a marked reduction of
self-reported anosmia/hyposmia, a reduction of cough and a tendency
to lower viral loads and lower IgG titers which warrants assessment
in larger trials.

Funding

ISGlobal, Barcelona Institute for Global Health and Clinica
Universidad de Navarra.

Keywords

Ivermectin
SARS-CoV-2
COVID-19
Anosmia
Hyposmia
Recommended articlesCiting articles (0)
View Abstract
(c) 2021 The Author(s). Published by Elsevier Ltd.

Recommended articles

No articles found.

Citing articles

Article Metrics

View article metrics
Elsevier logo

  * About ScienceDirect
  * Remote access
  * Shopping cart
  * Advertise
  * Contact and support
  * Terms and conditions
  * Privacy policy

We use cookies to help provide and enhance our service and tailor
content and ads. By continuing you agree to the use of cookies.

Copyright (c) 2021 Elsevier B.V. or its licensors or contributors. 
ScienceDirect (r) is a registered trademark of Elsevier B.V.

ScienceDirect (r) is a registered trademark of Elsevier B.V.