Efficacy and Safety of Ivermectin and Hydroxychloroquine in Patients with Severe COVID-19: A Randomized Controlled Trial
Beltran Gonzalez et al.
, Efficacy and Safety of Ivermectin and Hydroxychloroquine in Patients with Severe COVID-19: A Randomized..
, Infectious Disease Reports, doi:10.3390/idr14020020 (date from earlier preprint)
RCT late stage severe condition (93% SOFA ≥ 2, 96% APACHE ≥ 8) high
comorbidity hospitalized patients in Mexico with 36 low dose ivermectin and
37 control patients not finding significant differences. NCT04391127 (history)
Another study reports results on a larger group of patients in
the same hospital, showing ivermectin mortality RR 0.81 [0.53-1.24] [Guzman]
Questions have been raised about this study and the early
termination of the study and discontinuation of treatments, because the
hospital statistics show a dramatically lower (~75%) case fatality rate
during the period of the study 
(data from [gob.mx]
Several other inconsistencies have been reported
Although the data from this study is reported to be available
and has been shared with an anti-treatment group, independent researchers have
been unable to obtain the data for verification [Chamie, ]
This study is excluded in the after exclusion results of meta
major inconsistencies reported and the data is no longer available, although the authors state that it is available, and have shared it with an anti-treatment group.
risk of death, 14.4% lower, RR 0.86, p = 1.00, treatment 5 of 36 (13.9%), control 6 of 37 (16.2%), NNT 43.
risk of respiratory deterioration or death, 8.6% lower, RR 0.91, p = 1.00, treatment 8 of 36 (22.2%), control 9 of 37 (24.3%), NNT 48.
risk of no hospital discharge, 37.0% higher, RR 1.37, p = 0.71, treatment 4 of 36 (11.1%), control 3 of 37 (8.1%).
hospitalization time, 20.0% higher, relative time 1.20, p = 0.43, treatment 36, control 37, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Beltran Gonzalez et al., 23 Feb 2021, Double Blind Randomized Controlled Trial, Mexico, peer-reviewed, mean age 53.8, 13 authors, average treatment delay 7.0 days, dosage 12mg single dose, 18mg for patients >80kg.
Efficacy and Safety of Ivermectin and Hydroxychloroquine in
Patients with Severe COVID-19: A Randomized
Jose Lenin Beltran Gonzalez 1 , Mario González Gámez 1, *, Emanuel Antonio Mendoza Enciso 1 ,
Ramiro Josue Esparza Maldonado 1 , Daniel Hernández Palacios 1 , Samuel Dueñas Campos 1 , Itzel Ovalle Robles 1 ,
Mariana Jocelyn Macías Guzmán 1 , Andrea Lucia García Díaz 1 , César Mauricio Gutiérrez Peña 1 ,
Lucila Martinez Medina 2 , Victor Antonio Monroy Colin 2 and Jose Manuel Arreola Guerra 1, *
Citation: Beltran Gonzalez, J.L.;
González Gámez, M.; Mendoza
Enciso, E.A.; Esparza Maldonado,
R.J.; Hernández Palacios, D.; Dueñas
Campos, S.; Robles, I.O.; Macías
Guzmán, M.J.; García Díaz, A.L.;
Gutiérrez Peña, C.M.; et al. Efficacy
and Safety of Ivermectin and
Hydroxychloroquine in Patients with
Severe COVID-19: A Randomized
Controlled Trial. Infect. Dis. Rep. 2022,
14, 160–168. https://doi.org/
Academic Editor: Nicola Petrosillo
Received: 17 January 2022
Accepted: 25 February 2022
Published: 3 March 2022
Publisher’s Note: MDPI stays neutral
with regard to jurisdictional claims in
Internal Medicine Department Centenario Hospital Miguel Hidalgo, Aguascalientes 20259, Mexico;
email@example.com (J.L.B.G.); firstname.lastname@example.org (E.A.M.E.);
email@example.com (R.J.E.M.); firstname.lastname@example.org (D.H.P.); email@example.com (S.D.C.);
firstname.lastname@example.org (I.O.R.); email@example.com (M.J.M.G.); firstname.lastname@example.org (A.L.G.D.);
Pediatrics Department Centenario Hospital Miguel Hidalgo, Aguascalientes 20259, Mexico;
email@example.com (L.M.M.); firstname.lastname@example.org (V.A.M.C.)
Correspondence: email@example.com (M.G.G.); firstname.lastname@example.org (J.M.A.G.)
Abstract: During the first year of the COVID-19 pandemic, unauthorized drugs were widely used.
Ivermectin and hydroxychloroquine are drugs that inhibit viral replication in vitro and that have
been used in several medical centers. This clinical trial analyzes their efficacy in hospitalized patients
with moderate COVID-19. Methods: This a controlled, clinical, randomized, double-blind trial
that included hospitalized patients with COVID-19-induced pneumonia, without severe respiratory
failure. Patients were randomized to one of three groups: Group 1—hydroxychloroquine, 400 mg
every 12 h on the first day and, subsequently, 200 mg every 12 h for 4 days; Group 2—ivermectin,
12 mg or 18 mg, according to patient weight; and Group 3—placebo. At inclusion, blood samples for
arterial blood gases and biochemical markers were obtained. The primary outcome was established
as the length of stay due to patient improvement and the rate of respiratory deterioration or death.
Results: During the month of August 2020, the admission of patients requiring hospitalization mostly
encompassed cases with severe respiratory failure, so we ended the recruitment process and analyzed
the data that was available at the time. One hundred and six (106) patients with an average age of
53 yrs (±16.9) were included, with a greater proportion of males (n = 66, 62.2%). Seventy-two percent
(72%) (n = 76) had an associated comorbidity. Ninety percent (90%) of patients were discharged due to
improvement (n = 96). The average duration of hospitalization was 6 days (IQR, 3–10). No difference
in hospitalization duration was found between the treatment groups (Group1: 7 vs. Group 2: 6 vs.
Group 3: 5, p = 0.43)..
is less effective
Please send us corrections, updates, or comments. Vaccines and
treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, or intervention
is 100% available and effective for all current and future variants. We do not
provide medical advice. Before taking any medication, consult a qualified
physician who can provide personalized advice and details of risks and
benefits based on your medical history and situation. FLCCC
provide treatment protocols.