Researchers from health systems conducted a retrospective observational study out of the Dominican Republic, a nation that has been using ivermectin for a considerable time during the pandemic. The president of one of the financiers of this study, Grupo Rescue, was interviewed by TrialSite back in June 2020. Their results were published in the Journal of Clinical Trials recently, a Belgian-based peer-review journal. In this real-world structured case series conducted by Centro Medico Bournigal (CMBO) and the Centro Medico Punta Cana (CMPC), all patients were treated compassionately with Ivermectin and Azithromycin between May 1st to August 10th, 2020. They opted for this approach as the medical establishment in this Caribbean island nation has based their decision on existing observational data, including case series initiatives there. They haven’t had the luxury to conduct long-term, randomized controlled trials. This study included 3,099 patients with definite or highly probable diagnosis of COVID-19. Out of this population, a total of 2,706 (87.3%) patients were discharged for outpatient treatment, all with mild severity associated with COVID-19. Of those receiving outpatient treatment, an overwhelming 2,688 or 99.33% didn’t experience disease progression at all, including hospitalization; there were no deaths reports in this cohort. Of those in outpatient care that did require hospitalization, the total was only 16 (0.59%) and no associated deaths. Of the entire outpatient population, only 2 (0.08%) required admission to Intensive Care Unit (ICU) and 1 (0.04%) passed away. Of the 411 (13.3%) patients hospitalized, 300 (9.7%) of them developed moderate disease and 3 (1%) passed away. 111 (3.6%) of those were diagnosed with severe to critical disease in the ICU and 34 (30.6%) died. Hence, the mortality percentage of patients admitted to the ICU of 30.6% is similar to those found in the literature elsewhere of 30.9% at the time of study onset. The Dominican investigators report that, however, out of total mortality rate of this study, that is 37 patients or 1.2% of total, that the results are considerably lower than world statistics.
This study obviously has limitations that will be pointed out by industry watchers and critics. That it’s not a randomized, controlled study but rather a retrospective observational study, which carries less evidentiary weight among the world’s major health research and regulatory authorities, such as the U.S. National Institutes of Health and the U.S. Food and Drug Administration (FDA). Regardless, TrialSite can attest after interviews and chronicling off label use in that country that considerable representation in the health sector there have reported amazing results. In the early treatment group with only one death and only 16 progressing to the hospital, the real world data output is frankly unparalleled in other countries.
Study Conclusion Summary
The establishment of early treatment with ivermectin and azithromycin was highly successful as the infection failed to progress in 99.3% of the patient cohort totaling 2,706. On average, early treatment was triggered at 3.6 day from the onset of symptoms. Moreover, those in this group didn’t experience subsequent hospitalization nor death. Moreover, the fatality rates in the critical patients hospitalized in the ICU was comparable to those reported in the global literature. When totaling all mortality, the sum of those patients in outpatient treatment and hospitalized patients treated with ivermectin came out to 1.2%, which is well below the average of 3% reported in most case series and overall mortality reported worldwide by the time of onset of this study.
Of course, critics can further pick apart death rates, look at levels of comorbidity, and other factors present, but again health care research and regulatory bodies in places such as America and in Europe should seriously review these findings.
Grupo Rescue contributed financially to this study. Again, TrialSite interviewed the president of this organization, the largest private health system in the country. Also, the National Network of Health Services of the Dominican Republic contributed financial resources to the study.
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José Morgenstern, MD, Department of Infectious Diseases, Adviser, Centro Médico Punta Cana, Dominican Republic.
For a list of other authors, follow the link to read the study in Journal of Clinical Trials.
Call to Action: The output of this study falls under the category of real world evidence that should be considered by research authorities and regulators in other nations.