Yet another peer-reviewed observational study demonstrates that hydroxychloroquine contributes to the positive side of the argument for the use of this drug in the fight against COVID-19. However, the historical leanings don’t favor these antimalarial drug “camps” as the US Food and Drug Administration (FDA) withdrew emergency use authorization, and a handful of important studies have found that the drug doesn’t have an impact. Yet the research continues. Not long ago, TrialSite reported on the Henry Ford Health System findings that the malaria drug cuts the COVID-19 death rates, yet nearly right after the announcement of the findings, Dr. Anthony Fauci bypassed any scientific dialogue with the premier Michigan health system and declared to members in Congress that the study was “flawed.” That’s because Fauci is in the dominant camp that has already made up their minds based on a handful of studies. TrialSite isn’t “pro hydroxychloroquine” or “against.” There are several ongoing studies. In this case, a prestigious Italian research collaborative led an observational study—which carries less evidentiary weight than an interventional study—revealing that the use of this controversial drug reduces by 30% the risk of death in hospitalized patients affected by COVID-19.
Who were the Study Sponsors & Participants?
This study, published in the European Journal of Internal Medicine, was coordinated by the Department of Epidemiology and Prevention of the IRCCS Neuromed, Pozzilli, in collaboration with Mediterranea Cardiocentro Naples and the University of Pisa, with the participation of 33 hospitals forming the CORIST collaboration (COvid-19 RISk and Treatments).
The study findings were based on 3,451 patients treated in 33 hospitals throughout the Italian territories. The researchers analyzed data regarding current and previous diseases, therapies followed before the infection, and drugs administered in the hospital, specifically for the treatment of COVID-19. All this information was compared with the evolution and final in-hospital outcome of the infection
According to Augusto Di Castelnuovo, epidemiologist at the Neuromed Department of Epidemiology and Prevention, currently at Mediterranea Cardiocentro in Naples—“patients treated with hydroxychloroquine had a 30% lower in-hospital mortality rate compared to those not receiving this treatment.” The researcher emphasized that the study data was based on “extremely rigorous statistical analysis, taking into account all the variables and possible confounding factors that could come into play.” The study results were based on the segmentation of various patient subgroups. The researchers found that the positive results of the malaria drug didn’t change, even with patients experiencing more severe conditions such as inflammation during hospital admission, reports Di Castelnuovo.
Key Point of Research
These researchers concur with the world’s researchers that until a truly safe and effective vaccine(s) is developed and successfully commercialized, the introduction of effective and economical therapies to reduce the severity and death rate of COVID-19 represents an absolute priority, suggests Licia Iacoviello, Director of the Department of Epidemiology and Prevention at Neuromed. Iacoviello is also a professor of Public Health at the University of Insubria at Varese.
More Evidence Needed: Italians Concur
These scientists acknowledged that this particular study isn’t enough to settle any international debate on the role of hydroxychloroquine in the treatment of hospitalized patients for COVID-19. Rather, additional studies will be required—observational studies and the results of ongoing clinical trials are necessary to help the scientific and medical community better access the role of the drug and the most appropriate administration methods. But according to this Italian group, the CORIST collaboration results support the continued use of hydroxychloroquine. In this study, they note that the doses (200 mg twice a day) were lower than many of the other studies using the drug worldwide.
Giovanni de Gaetano, President of Neuromed, commented that the World Health Organization first recommended stopping the drug’s use, then retracted, and now with CORIST study results, the hope is a contribution to the clarification of the role of the drug in treating the coronavirus.
The CORIST Collaboration
CORIST (COvid-19 RISk and Treatments) is a collaboration between 33 Italian clinical centers devoted to collecting and studying data relating to COVID-19 patients. It is a study carried out in the “real life” of the Italian National Health System, bringing together the different experiences of large and small clinical centers from Lombardy to Sicily.
The IRCCS Neuromed
The Institute for Research, Hospitalization and Health Care (IRCCS) Neuromed in Pozzilli (Italy) is a landmark at the Italian and international level for research and therapy in neurological and cardiovascular diseases. A center in which doctors, researchers, staff, and the patients themselves form an alliance aimed at ensuring the best level of service and cutting-edge treatments, guided by the most advanced scientific developments.
Call to Action: According to many prominent investigators and leaders of research agencies, the debate is over—hydroxychloroquine doesn’t contribute to an effective way of treating COVID-19. But there isn’t by any means an accordance here as prominent health system and research institute findings continue to reveal the possibility of an alternative position. For example, are these most recent findings by prominent Italian researchers simply wrong because they are based on an observational study? What is the truth at this point when it comes to hydroxychloroquine and its use against COVID-19? The reality is that the balance of evidence probably leans against it as an effective drug, but studies keep surfacing that point to a different possible reality. Not one group can conclusively claim to be the bearers of the truth. In fact, if they claim to be so—readers, be leery of such confident messengers because they are full of hubris at best and politically charged in more extreme cases.