A team of doctors, pharmacists and health professionals received approval from Broward Health’s Board for a retrospective, cohort study of consecutive patients hospitalized with COVID-19. They recently published the results revealing that ivermectin is associated with lower mortality during treatment of COVID-19, especially in patients who required higher inspired oxygen or ventilatory support. Led by Dr. Jean-Jaques Rajter, the team acknowledges that although the results are based on observational data, the findings should prompt interest in randomized controlled trials to further pursue this economical and widely available anti-parasitic drug as a possible treatment for COVID-19.
The Early News Showcases Growing Interest in Ivermectin
TrialSite News reported on the work of Dr. Jean-Jaques Rajter and his spouse, Juliana Cepelowicz Rajter, in late April. After an interview with the inspired, passionate and dedicated physician, as well as other researchers investigating ivermectin’s potential against COVID-19 around the world, it became more apparent that there was a growing momentum around ivermectin research. Thanks to the approval of Broward County Health board, the off-label protocol effort in Florida was able to proceed.
The Observational Study
Hence the Broward Health study team set out to determine if ivermectin was associated with a lower mortality rate in patients hospitalized with COVID-19. They set up a retrospective cohort study of consecutive patients hospitalized at four Broward Health hospitals in South Florida with confirmed SARS-CoV-2.
The team enrolled participants between Match 15, 2020 and May 11, 2020. In total they treated 280 patients with confirmed COVID-19 infection with a mean age of 59.6 years old (standard deviation 17.9). 45.4% of the patients were female. Of the total patient base, 173 were treated with ivermectin and 107 were given standard of care. 27 identified patients were not reviewed due to multiple admissions as well as lack of confirmed COVD-19 results during hospitalization or other factors such as incarceration.
In regards to drug exposure the doctors categorized patients into two treatment groups based on whether they had received at least one dose of ivermectin during the hospitalization. Any and all treatment decisions were based on the professional discretion of the treating physicians. In regards to study entry any severe pulmonary involvement was characterized as a need for either FiO2 ≥50%, or noninvasive or invasive mechanical ventilation.
With a primary outcome of all-cause in-hospital mortality and secondary outcomes including subgroup mortality in patients with severe pulmonary involvement and extubation rates for patients requiring invasive ventilation, the doctors recently shared the published results via preprint server.
These results, albeit not from a randomized controlled trial, are promising. A univariate analysis reveals lower mortality rate in the ivermectin group (25.2% versus 15.0%, OR 0.52, 95% CI 0.29-0.96, P=0.3). The Broward County team also found that mortality was lower among 75 patients with severe pulmonary disease treated with ivermectin (38% vs. 80.7%, OR 0.15, CI 0.05-0.47,P=.001), but there was no significant difference in successful extubation rates (36% vs 15.4%, OR 3.11 (0.88-11.00), p=.07).
The study team found that once adjusting for between group differences and mortality risks, actual mortality difference remained significant for the entire cohort OR 0.27, CI 0.09-0.85, p=.03; HR 0.37, CI 0.19-0.71, p=.03) .
Hence, the team led by Dr. Rajter suggest ivermectin is, in fact, associated with lower mortality during treatment of COVID-19, especially in patients who require higher inspired oxygen or ventilatory support. The study team acknowledge that these findings are based on observational study data—and not based on a randomized controlled study and hence clinical trials should be organized to pursue this promising pathway.
Broward Health made this study possible. The Broward Health Board approved the off-label protocol. Officially known as the North Broward Hospital District (d/b/a Broward Health), the health district is governed by a seven-member Board of Commissioners.
Michael Sherman, MD, Drexel University
Naaz Fatteh, MD, Broward Health Medical Center
Fabio Vogel, Supervisor Pharmacy Operations, Broward Health Medical Center
Jamie Sacks, Broward Health Medical Center
Call to Action: TrialSite News has been following ivermectin research around the world and believe that there is enough information now justifying investment in research programs—the potential as an economical and available treatment cannot be ignored.