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Effectiveness of a multidrug therapy consisting of ivermectin, azithromycin, montelukast and acetylsalicylic acid to prevent hospitalization and death among ambulatory COVID-19 cases in Tlaxcala, Mexico

Lima-Morales et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2021.02.014
Feb 2021  
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Mortality 78% Improvement Relative Risk Ventilation 52% Hospitalization 67% Recovery 59% Montelukast  Lima-Morales et al.  LATE TREATMENT Is late treatment with montelukast + combined treatments beneficial for COVID-19? Prospective study of 768 patients in Mexico Lower mortality (p=0.001) and hospitalization (p=0.001) c19early.org Lima-Morales et al., Int. J. Infectiou.., Feb 2021 Favorsmontelukast Favorscontrol 0 0.5 1 1.5 2+
29th treatment shown to reduce risk in November 2021, now with p = 0.0041 from 9 studies.
Lower risk for hospitalization and cases.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19early.org
Prospective trial of 768 COVID-19 outpatients in Mexico, 481 treated with ivermectin, AZ, montelukast, and aspirin, and 287 control patients with various treatments, showing significantly lower mortality and hospitalization, and significantly higher recovery at 14 days with treatment.
This study is excluded in meta analysis: combined treatments may contribute more to the effect seen.
Study covers ivermectin, montelukast, and aspirin.
risk of death, 77.7% lower, RR 0.22, p < 0.001, treatment 15 of 481 (3.1%), control 52 of 287 (18.1%), NNT 6.7, adjusted per study, odds ratio converted to relative risk, multivariate.
risk of mechanical ventilation, 51.9% lower, RR 0.48, p = 0.15, treatment 8 of 434 (1.8%), control 11 of 287 (3.8%), NNT 50.
risk of hospitalization, 67.4% lower, RR 0.33, p < 0.001, treatment 44 of 481 (9.1%), control 89 of 287 (31.0%), NNT 4.6, adjusted per study, odds ratio converted to relative risk, multivariate.
risk of no recovery, 58.6% lower, RR 0.41, p < 0.001, treatment 75 of 481 (15.6%), control 118 of 287 (41.1%), NNT 3.9, adjusted per study, inverted to make RR<1 favor treatment, odds ratio converted to relative risk, recovery at day 14 after symptoms, multivariate.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Lima-Morales et al., 10 Feb 2021, prospective, Mexico, peer-reviewed, 10 authors, average treatment delay 7.2 days, this trial uses multiple treatments in the treatment arm (combined with azithromycin, montelukast, and aspirin) - results of individual treatments may vary.
This PaperMontelukastAll
Effectiveness of a multidrug therapy consisting of Ivermectin, Azithromycin, Montelukast, and Acetylsalicylic acid to prevent hospitalization and death among ambulatory COVID-19 cases in Tlaxcala, Mexico
René Lima-Morales, Pablo Méndez-Hernández, Yvonne N Flores, Patricia Osorno-Romero, Christian Ronal Sancho-Hernández, Elizabeth Cuecuecha-Rugerio, Adrián Nava-Zamora, Diego Rolando Hernández-Galdamez, Daniela Karola Romo-Dueñas, Jorge Salmerón
International Journal of Infectious Diseases, doi:10.1016/j.ijid.2021.02.014
There is an urgent need for effective treatments to prevent or attenuate lung and systemic inflammation, endotheliitis, and thrombosis related to COVID-19. This study aimed to assess the effectiveness of a multidrug-therapy consisting of Ivermectin, Azithromycin, Montelukast, and Acetylsalicylic acid ("TNR4" therapy) to prevent hospitalization and death among ambulatory COVID-19 cases in Tlaxcala, Mexico. Design and methods: A comparative effectiveness study was performed among 768 confirmed SARS-CoV-2 cases aged 18-80 years, who received ambulatory care at the Ministry of Health of Tlaxcala. A total of 481 cases received the TNR4 therapy, while 287 received another treatment (comparison group). All participants received home visits and/or phone calls for clinical evaluation during the 14 days after enrollment. Results: Nearly 85% of cases who received the TNR4 recovered within 14 days compared to 59% in the comparison group. The likelihood of recovery within 14 days was 3.4 times greater among the TNR4 group than in the comparison group. Patients treated with TNR4 had a 75% and 81% lower risk of being hospitalized or death, respectively, than the comparison group. Conclusions: TNR4 therapy improved recovery and prevented the risk of hospitalization and death among ambulatory COVID-19 cases.
Differences between means were estimated from linear regression, and differences between proportions were evaluated using the chi2 test. A p-value 0.05 was considered to be significant. Proportions and means were adjusted by age, sex, comorbidities, and occupation. A p-value 0Á05 was considered significant. a Comparison group: participants who did not accept the TNR4 treatment because they were asymptomatic, were already taking another treatment, or they had self-medicated for cold and flu. However, they agreed to take part in the follow-up portion of the study. Conflict of interest The authors declare no conflict of interest in this article. Ethical approval Approval for this study was granted by the Ministry of Health of the Tlaxcala state, Mexico (#CEI02092020).
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Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment 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 and WCH provide treatment protocols.
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