Recently, a TrialSite News reader shared an interesting but not peer-reviewed, nor formally published study that we republish for others to review and scrutinize. The authors, Amit N. Patel, MD; Sapan S. Desai, MD, PhD, MBA; David W. Grainger, PhD; and Mandeep R. Mehra, MD, MSc, introduce a retrospective observational study as to the benefits of the drug ivermectin when applied to patients infected with SARS-CoV-2, the virus behind the COVID-19 epidemic. Upon a review of the paper, it is not clear where the actual underlying data originates from. TrialSite News includes the study abstract (with a link to the actual study) and offers a summary breakdown below.
TrialSite News includes an assessment of this study from a popular YouTube channel.
Who are the authors?
Amit N. Patel is associated with the University of Utah, Department of Bio-engineering and HCA Research Institute in Florida. Sapan S. Desai, MD, PhD, MBA, is employed by Surgisphere Corporation in Chicago, IL. David W. Grainer, PhD, is with the University of Utah, Department of Bio-engineering. Mandeep R. Mehra, MD, MSc is affiliated with 4Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA.
How many patient records do they claim to have reviewed?
The authors purport to have reviewed over 68,000 patient records from 169 hospitals around the world. Of the 68,000 reviewed, they selected 1,408 propensity-matched patients. The authors claim this data was accessed via a registry (mentioned below), but we have some questions about that registry.
What are their key points?
Well, they raise the question, does the antimicrobial drug, ivermectin, influence the outcome in COVID-19 illness? They answer by declaring that based on this observational propensity-matched case-controlled study in 1,408 patients (704 that received ivermectin and 704 that did not) demonstrates an association of ivermectin use with lower in-hospital mortality—1.4% versus 8.5% (Ivermectin vs. No Ivermectin); HR 0.20 CL 95%, 0.11-0.37, P.
What is their conclusion and Setting?
Ivermectin is associated with a potential survival benefit in COVID-19, and this should be investigated urgently in randomized controlled trials. The data is derived from an international multi-institutional de-identified healthcare outcomes database.
What was the study design?
An international, multicenter, observational propensity-score matched case-controlled study using prospectively collected data on patients diagnosed with COVID-19 between January 1, 2020 and March 31, 2020.
Where is the data from?
The authors report de-identified data on patients, and their outcome was obtained from a registry (Surgical Outcomes Collaborative, Surgisphere Corporation, Chicago, IL). When reviewing what appears to be the data source, Quartz Clinical, it is not apparent where this data comes from.
What is Surgisphere?
Surgisphere is a Chicago-based corporation founded by one of the authors (Sapan S. Desai) as a healthcare data analytics and medical education company. It markets the “Quartz Clinical” product, which purports to offer “sophisticated analytics, benchmarking, and machine learning for healthcare organizations.” The venture has been around for over a decade, but still only counts four employees associated with the venture on LinkedIn. It is not clear where the underlying patient registry—Surgical Outcomes Collaborative—is securing its data from.
What were the dosages involved?
Ivermectin (150mcg/Kg) administered once compared with COVID-19 patients receiving medical therapy without ivermectin.
Summary of results?
The cohort (including 704 ivermectin treated and 704 controls) was derived from 169 hospitals across three continents with COVID-19 illness. The patients were matched for age, sex, race or ethnicity, comorbidities, and an illness severity score (qSOFA). Of those requiring mechanical ventilation, fewer patients died in the ivermectin group (7.3% versus 21.3%), and overall death rates were lower with ivermectin (1.4% versus 8.5%; HR 0.20 CI 95% 0.11-0.37, P.)
What conclusion is drawn by the authors?
“The administration of ivermectin during COVID-19 illness in hospitalized patients is associated with a lower mortality and hospital length of stay. These findings require confirmation in randomized controlled trials.”
Call to Action: We have sent requests to these authors for interviews. We would like to understand the underlying methodology, data sources, and assumptions behind this study. If we are able to secure more information, we will certainly share whatever we can find.