Broward Health Observational Study: Ivermectin is Associated with Lower Mortality for COVID-19 Hospitalized Patients

Jun 9, 2020 | Blog, Broward County Health, COVID-19, Ivermectin, News, SARS-CoV-2

Broward Health Observational Study Ivermectin is Associated with Lower Mortality for COVID-19 Hospitalized Patients

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-Jaque 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-Jaque 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.

Discussion

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) .

Conclusion

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

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

Lead Research/Investigator

Juliana Cepelowicz Rajter, MD 

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

Jean-Jaque Rajter, MD

Call to ActionTrialSite 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.  

Source: MedRxiv

8 Comments

  1. Name abhishek jain

    CommentIvermectin कई प्रकार के परजीवी संक्रमणों के इलाज के लिए उपयोग की जाने वाली दवा है । [1] इसमें शामिल हैं सिर जूँ , खुजली , नदी अंधापन (onchocerciasis), strongyloidiasis , trichuriasis , एस्कारियासिस , और लसीका फाइलेरिया । [१] [२] [३] [४] इसे मुंह से लिया जा सकता है या बाहरी संक्रमण के लिए त्वचा पर लगाया जा सकता है। [१] [५] आँखों में उपयोग से बचना चाहिए। [1]
    आम साइड इफेक्ट्स में लाल आँखें , शुष्क त्वचा और जलती हुई त्वचा शामिल हैं। [१] यह स्पष्ट नहीं है कि यह गर्भावस्था के दौरान उपयोग के लिए सुरक्षित है , लेकिन संभवतः स्तनपान के दौरान उपयोग के लिए स्वीकार्य है । [६] यह दवाओं के औसत परिवार के अंतर्गत आता है। [१] यह परजीवी की कोशिका झिल्ली को पारगम्यता में वृद्धि का कारण बनता है , जिसके परिणामस्वरूप पक्षाघात और मृत्यु होती है। [1]
    Ivermectin 1975 में खोजा गया था और 1981 में चिकित्सा उपयोग में आया था। [7] [8] यह विश्व स्वास्थ्य संगठन की आवश्यक दवाओं की सूची में है । [९] गोलियों के लिए विकासशील दुनिया में थोक लागत लगभग of.१२ अमेरिकी डॉलर है। [१०] संयुक्त राज्य अमेरिका में, लागत ५० अमेरिकी डॉलर से कम है। [११] [१२] अन्य जानवरों में इसका उपयोग अन्य बीमारियों के बीच हृदय की धड़कन को रोकने और इलाज के लिए किया जाता है। [3]

  2. abhishek jain

    COVID-19 पर Ivermectin कैसे काम करता है?
    • SARS-CoV-2 वायरस के लिए आपको बीमार करने के लिए, इसे पहले आपकी कोशिकाओं को संक्रमित करना होगा।
    • फिर सेल के अंदर रहते हुए, वायरस खुद की प्रतियों का ढेर बनाता है, इसलिए यह आपके शरीर में फैल सकता है।
    • वायरस आपके शरीर को संक्रमण से लड़ने के तरीके को कम करने के तरीके भी हैं।
    • सेल के संक्रमण के दौरान, कुछ वायरल प्रोटीन सेल न्यूक्लियस में चले जाते हैं, और यहां से वे वायरस से लड़ने की शरीर की क्षमता को कम कर सकते हैं, जिसका अर्थ है कि संक्रमण बदतर हो सकता है।
    • नाभिक में जाने के लिए वायरल प्रोटीन को एक कार्गो ट्रांसपोर्टर को बांधने की आवश्यकता होती है जो उन्हें अंदर जाने देती है।
    • Ivermectin कार्गो ट्रांसपोर्टर को ब्लॉक कर सकता है, इसलिए वायरल प्रोटीन नाभिक में नहीं मिल सकता है। वैज्ञानिकों का मानना है कि Ivermectin SARS-CoV-2 वायरस के खिलाफ काम करता है।
    • Ivermectin लेने से इसका मतलब है कि शरीर सामान्य की तरह संक्रमण से लड़ सकता है, क्योंकि वायरल प्रोटीन द्वारा इसकी एंटीवायरल प्रतिक्रिया कम नहीं हुई है।

  3. John H

    Note that under “Lead Research/Investigator” it still lists “Julian”. Should be “Juliana”.

    • TrialSite

      Hello- Thank you- we’ve been working on fixing that in the backend- there was glitch with the link and prior typo. Should be fixed.

  4. Merrel Holley

    “A univariate analysis reveals lower mortality rate in the ivermectin group (25.2% versus 15.0%” Is this correct, or is it the inverse?

    • TrialSite

      Hello and thanks for visiting the site. This was how the numbers were written in the report. The mortality rate was lower so hence the lower figure would be the number. There are limitations with univariate analysis in that it is a very basic statistical measurement–e.g only one variable and no ability to look at causes or relationships but as a basic descriptive measure–in the context of an observational study such as this–it gives us some data points but we will need randomized controlled study.

      Regards,
      Publisher

  5. Patricia

    I’m glad for the support of this investigation. I know personally doctors JJ and Juliana and both are great human been and physicians.

    • TrialSite

      Dear Patricia,
      Yes they are great people–committed doctors to an important cause. We very much support their efforts to organize a regional or even national randomized controlled trial. We have too many data points from around the world that this therapy appears to work but we need to develop more data for a rock-solid position.
      Thanks for visiting.
      Publisher

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