This large retrospective observational population study out of Mexico is a testament to the benefits of treating mild outpatient Covid-19 cases with a medical kit at home. They found that the incidence of hospitalization was only 6.14% in patients who received a kit and 11.71% in those who did not. In the multivariate model, receiving a medical kit was associated with a lower risk of hospitalization or death from COVID-19: adjusted risk ratio 0.35 (95% confidence interval 0.30–0.40).
Background
This retrospective, two-group comparative study was sponsored by the Mexican Institute of Social Security (Instituto Mexicano del Seguro Social, (IMSS), a system providing healthcare to about 68 million people or 54% of the Mexican population. Operating approximately 1,400 primary care medical units, 270 general community hospitals, and 25 tertiary and quaternary care medical centers distributed throughout the 32 Mexican states.
During the pandemic, IMSS implemented respiratory care modules in a bid to classify and care for COVID-19 patients. For the cohort of patients with mild COVID-19 without respiratory symptoms, a large study was set up comparing a group that received the treatment kit with those that did not.
The treatment kits included an information brochure, face masks, a pulse oximeter, a three-day course of azithromycin (500 mg on day 1, 250 mg on days 2 and 3), a two-day course of ivermectin 6 mg daily, and several acetaminophen and aspirin tablets. The ivermectin and aspirin are likely to be what provided the benefits. The ivermectin dosing was much too low, but still probably helped. The aspirin would help prevent the microthrombosis that is so prevalent in Covid-19. Many believe microthrombosis is the main driver of severe disease in Covid-19. There is also evidence that platelet agglutination is the initial stage of the thrombosis in Covid-19.
The study team included a total of 28,048 laboratory-confirmed SARS-CoV-2 patients: 7,898 (28.2%) received a medical kit and 20,150 (71.8%) did not. The incidence rates of hospitalization and death combined were calculated.
The Study Methods
This study was designed to investigate the hospitalization and mortality rates of a large sample of adults who received the primary treatment kit in comparison with an equally large cohort of patients who declined the kit yet continued monitoring via telehealth.
A retrospective, two-group comparative study was conducted with secondary data via the National Family Medicine Information System of the IMSS. This database contains the personal and clinical records of every patient, including their diagnosis and prescribed medications. All data is captured in real-time by the family physician while attending to the patient.
A second database was set up by the epidemiological surveillance system at the IMSS covering the period of February 1-May 16, 2021. The data corresponded to ambulatory patients aged 18 years and older and over with confirmed COVID-19 diagnosis and with information about the treatment kit delivery only. Records from the second epidemic wave from January 1–August 30, 2021, were analyzed. The study team included data regarding sex, age, medical conditions (e.g., obesity, hypertension, diabetes, cardiovascular disease), follow-up by telephone, and whether they agreed to use the treatment kit was obtained for each patient, as well emergency room visits and hospitalization. Information regarding death was obtained and verified using the hospital and mortality registries.
Results
The study authors, led by Cesar Raul Gonzalez-Bonilla, Evidence Analysis and Synthesis Research Unit, Health Research Coordination, Education and Research Unit, Medical Benefits Directorate, Mexican Institute of Social Security, report that those mild COVID-19 patients receiving the home treatment kit had a hospitalization rate of 6.14% as compared to the cohort not receiving the home treatment kit at 11.71%.
As is the case in other parts of North America, the authors report that comorbidities (e.g., obesity, diabetes, etc.) are associated with an increased risk of hospitalization or death. But those rates were reduced in the cohort that received early treatment or telephone follow-up.
Multivariate analysis revealed that the home-based mild COVID-19 patients receiving the home treatment kits were associated with a lower risk of hospitalization and death from COVID-19 with an adjusted risk ratio of 0.35 (95% confidence interval 0.30–0.40).
Summary
The authors conclude that a multimodal strategy of the type employed in Mexico could possibly reduce the risk of hospitalization and death in adult outpatients with mild COVID-19. Based on a review of dozens of randomized controlled trials, observational studies, and countless physician interviews, the study results here indicate that even a marginally efficacious inexpensive regimen can save lives, even when administered early. TrialSite goes on record that sending patients home with no treatment and only instructions to go to the emergency department if/when they become hypoxic was cruel and immoral. It also directly caused the deaths of hundreds of thousands of Americans.
Lead Research/Investigator
Cesar Raul Gonzalez-Bonilla, Ph.D. Evidence Analysis and Synthesis Research Unit, Health Research Coordination, Education and Research Unit, Medical Benefits Directorate, Mexican Institute of Social Security.