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All Studies   Meta Analysis       

Efficacy and Safety of Ivermectin and Hydroxychloroquine in Patients with Severe COVID-19: A Randomized Controlled Trial

Beltran Gonzalez et al., Infectious Disease Reports, doi:10.3390/idr14020020 (date from preprint)
Feb 2021  
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Mortality 14% Improvement Relative Risk Respiratory deterioration.. 9% Discharge -37% Hospitalization time -20% primary Ivermectin  Beltran Gonzalez et al.  LATE TREATMENT  DB RCT Is late treatment with ivermectin beneficial for COVID-19? Double-blind RCT 73 patients in Mexico Multiple inconsistencies and issues, see notes c19ivm.org Beltran Gonzalez et al., Infectious Di.., Feb 2021 Favorsivermectin Favorscontrol 0 0.5 1 1.5 2+
Ivermectin for COVID-19
4th treatment shown to reduce risk in August 2020, now with p < 0.00000000001 from 105 studies, recognized in 23 countries.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 110 treatments. c19ivm.org
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]1.
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 study2 (data from gob.mx).
DateCasesDeathsCFR
3/20202150%
4/20204125%
5/20201318%
6/20203725%
7/20206558%
8/2020792329%
9/2020541222%
10/2020622134%
11/2020802633%
12/2020411332%
Several other inconsistencies have been reported4.
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 verification4,5.
This is the 18th of 52 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000021.
This is the 40th of 105 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 774 quintillion).
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%).
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.
This PaperIvermectinAll
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.
References
Boulware, Pullen, Bangdiwala, Pastick, Lofgren et al., A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19, N. Engl. J. Med, doi:10.1056/NEJMoa2016638
Caly, Druce, Catton, Jans, Wagstaff, The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro, Antiviral Res, doi:10.1016/j.antiviral.2020.104787
Cavalcanti, Zampieri, Rosa, Azevedo, Veiga et al., Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19, N. Engl. J. Med, doi:10.1056/NEJMoa2019014
De Smet, De Smet, Ryckaert, Laridon, Heremans et al., Diagnostic Performance of Chest CT for SARS-CoV-2 Infection in Individuals with or without COVID-19 Symptoms, Radiology, doi:10.1148/radiol.2020202708
Geleris, Sun, Platt, Zucker, Baldwin et al., Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19, N. Engl. J. Med, doi:10.1056/NEJMoa2012410
Horby, Lim, Emberson, Mafham, Bell et al., Dexamethasone in Hospitalized Patients with Covid-19-Preliminary Report
Mega, Latin America's embrace of an unproven COVID treatment is hindering drug trials, Nature, doi:10.1038/d41586-020-02958-2
Momekov, Momekova, Ivermectin as a potential COVID-19 treatment from the pharmacokinetic point of view: Antiviral levels are not likely attainable with known dosing regimens, Biotechnol. Biotechnol. Equip, doi:10.1080/13102818.2020.1775118
Olson, Davis, Diagnosis and Treatment of Adults with Community-Acquired Pneumonia, JAMA, doi:10.1001/jama.2019.21118
Pan, Peto, Henao-Restrepo, Preziosi, Sathiyamoorthy et al., Repurposed Antiviral Drugs for Covid-19-Interim WHO Solidarity Trial Results, N. Engl. J. Med
Rajter, Sherman, Fatteh, Vogel, Sacks et al., Use of Ivermectin Is Associated with Lower Mortality in Hospitalized Patients with Coronavirus Disease 2019: The Ivermectin in COVID Nineteen Study, Chest, doi:10.1016/j.chest.2020.10.009
Roca, Caralt, Messika, Samper, Sztrymf et al., An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy, Am. J. Respir. Crit. Care Med, doi:10.1164/rccm.201803-0589OC
Ruiz, Jurado, Güeto, Yuste, García et al., Predictors of success of high-flow nasal cannula in the treatment of acute hypoxemic respiratory failure
Savarino, Boelaert, Cassone, Majori, Cauda, Effects of chloroquine on viral infections: An old drug against today's diseases, Lancet Infect. Dis, doi:10.1016/S1473-3099(03)00806-5
Schmith, Zhou, Lohmer, The Approved Dose of Ivermectin Alone is not the Ideal Dose for the Treatment of COVID-19, Clin. Pharmacol. Ther, doi:10.1002/cpt.1889
Zhai, Li, Chen, Gerotziafas, Zhang et al., Prevention and Treatment of Venous Thromboembolism Associated with Coronavirus Disease 2019 Infection: A Consensus Statement before Guidelines, Thromb Haemost, doi:10.1055/s-0040-1710019
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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. 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Late treatment
is less effective
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