A growing divide is observed between most of the regulatory and research establishment that now shuns Hydroxychloroquine, the once embraced investigational therapy for COVID-19 now evidenced by a majority of studies to not be effective. However, critics, and there are many physicians in the field, argue that most of these studies were designed in a flawed manner. Now an outspoken physician, Dr. Vladimir Zelenko and a German team declare in a press release that they completed a retrospective study analyzing his patient data and that the findings have been accepted for publication after a rigorous peer review process. The paper can be found in the International Journal of Antimicrobial Agents.
What is the Key Hypothesis Here?
Dr. Zelenko’s main hypothesis based on the data showing that early intervention and treatment of high-risk patients with COVID-19 results in significantly few hospitalizations and deaths. This treatment regimen involving zinc, low-dose hydroxychloroquine, and azithromycin is also apparently known as, “The Zelenko Protocol.”
Why is this Retrospective Study Unique?
According to the independent physician-sponsor, only high-risk out-patients were treated with the triple-drug regimen. According to Dr. Zelenko, high risk patients represent those individuals that have a 5% to 10% chance of dying from COVID-19. This category includes patients over 60, as well as those under 60 that have other medical issues or experience breathing problems. In this protocol all high-risk outpatients were treated at their initial visit, most within the first five days of the onset of symptoms. All patients were laboratory confirmed with COVID-19 infection.
Who Performed this Retrospective Analysis?
According to the sponsor, the retrospective analysis study was the result of the three doctors forming a rare synergy of industry, academia, and clinical medicine. The collaborators included Dr. Roland Derwand, a German physician and life science industry expert. The team also included Professor Martin Scholz, an independent consultant and adjunct professor for experimental medicine at Heinrich Heine University in Dusseldorf, Germany. It was these two German physician/researchers that first brought attention to “The Zelenko Protocol” in their published hypothesis paper about the importance of combining zinc with hydroxychloroquine as a method for treating COVID-19.
Who is Dr. Zelenko?
A family practitioner and major proponent of the use of hydroxychloroquine, zinc, and azithromycin to treat COVID-19, Dr. Zelenko has claimed to treat anywhere from 300 to 1,450 COVID-19 patients. According to the Physicians Weekly “Skeptical Scalpel Awards,” the publication was leery of the independent doctor’s claims declaring of his own research, “Those are mighty impressive numbers, but no one else has seen the data.” The author of this critique noted that a fact check at the website Snopes couldn’t verify his claims.
What the Published Study Reveals
Well, certainly not 300+ patients, however the doctor did treat 141 high-risk patients and reports that the risk stratification-based treatment of COVID-19 outpatients as early as practicable upon symptom onset. And the triple therapy (e.g. The Zelenko Protocol) was associated with significantly fewer hospitalizations. The overwhelming majority of the research, regulatory, and academic establishments have moved on from hydroxychloroquine. In fact, TrialSite has reported on difficulties in filling COVID-19 prescriptions for this drug in many states. Moreover, the emphasis during the pandemic has been on randomized controlled trials (RCTs), the gold standard for producing medical evidence.
However, reports have shown that many treatment strategies which are deemed “evidence based” were not ever subject to randomized controlled trials. Many doctors would consider it unethical as well to withhold a treatment that is deemed to help patents, particularly in a time of crisis. Unfortunately for the hydroxychloroquine camp, it appears to be an uphill battle as the societal forces are now “circling the wagon” on these economical, available therapies considered important for early treatment to reduce hospitalization. The same could be said for the controversial ivermectin which TrialSite has extensively chronicled.
Call to Action: TrialSite is pro-doctor and healthcare provider platform. These are heroes in our eyes. Their voices should be heard and respected. On the other hand, TrialSite is a neutral space and several studies using Hydroxychloroquine against COVID-19 haven’t produced sufficient evidence. Countering these, several doctors have voiced seemingly rational critiques of at least some of the study designs. Of concern, TrialSite does detect some politics associated with the subject of economical and available repurpose able drugs associated with COVID-19. Send us your comments and opinions.