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).
| Date | Cases | Deaths | CFR |
| 3/2020 | 2 | 1 | 50% |
| 4/2020 | 4 | 1 | 25% |
| 5/2020 | 13 | 1 | 8% |
| 6/2020 | 37 | 2 | 5% |
| 7/2020 | 65 | 5 | 8% |
| 8/2020 | 79 | 23 | 29% |
| 9/2020 | 54 | 12 | 22% |
| 10/2020 | 62 | 21 | 34% |
| 11/2020 | 80 | 26 | 33% |
| 12/2020 | 41 | 13 | 32% |
Several other inconsistencies have been reported
Chamie.
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
analysis:
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.
Study covers
HCQ and ivermectin.
|
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%).
|
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hospitalization time, 20.0% higher, relative time 1.20, p = 0.43, treatment 36, control 37, primary outcome.
|
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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 Controlled Trial
Jose Lenin Beltran Gonzalez, Mario González Gámez, Emanuel Antonio Mendoza Enciso, Ramiro Josue Esparza Maldonado, Daniel Hernández Palacios, Samuel Dueñas Campos, Itzel Ovalle Robles, Mariana Jocelyn Macías Guzmán, Andrea Lucia García Díaz, César Mauricio Gutiérrez Peña, Lucila Martinez Medina, Victor Antonio Monroy Colin, Jose Manuel Arreola Guerra
Infectious Disease Reports, doi:10.3390/idr14020020
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) (4) (5) (6) (7) (8) (9) (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) nor in respiratory deterioration or death (Group 1: 18% vs. Group 2: 22.2% vs. Group 3: 24.3%, p = 0.83). Conclusions: In non-critical hospitalized patients with COVID-19 pneumonia, neither ivermectin nor hydroxychloroquine decreases the number of in-hospital days, respiratory deterioration, or deaths.
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