Source: Trial Site News
A group of Texas-based providers, including physicians, some highly published, recently published in the International Journal of Innovative Research in Medical Science results of a case series type of study involving a group of 320 COVID-19 patients deemed high risk—that is, over 50 years old with at least one comorbidity.
The group actually was able to add 549 cases more by the end of the study period, which was December, 2020. This group of physicians, part of a small but vocal and dedicated camp, declare that during the pandemic, the medical profession disappointed, turning into “watchful watchers” for the vast majority of COVID-19 cases—and especially those cases that fit the study patient cateogry—desperately needing care.
The authors argue that in far too many cases, these at risk patients were acknowledged to have COVID-19, sent home, and told to return if symptoms worsened. Many people lost parents and grandparents due to this form of doctoring, which could be classified by one point of view as the active caring wing but yet by a mainstream as rogue.
This study is observational in nature (e.g. isn’t a randomized controlled trial) for the practitioners that provided the care as well as the framework for studious review and analysis of associated data—and results for them that matter. Based on the results, it most certainly did for the patients as well.
Using a protocol of zinc, hydroxychloroquine or ivermectin and one antibiotic (azithromycin, doxycycline, ceftriaxone) in combination with inhaled budesonide and/or intramuscular dexamethasone, the doctors, including accomplished researchers, such as Dr. Peter McCullough who have presented on TrialSite Podcast, sought to follow the Hippocratic oath and care for their COVID-19 patients—opting to take action and not passively stand by and do nothing.
They found a lot of misleading information circulating about, and ambulatory patients with some risk factors during the pandemic actually were facing great risk. While the introduction of emergency use monoclonal antibodies (Lilly and Regeneron) helped care for more of this class of patient, they still were not reaching enough patients—too many were dying.
The results of their observational, case series—based comparison study to the Cleveland Clinic COVID-19 hospitalization calculator as applied to four Texas counties where they practice—were notable.
The early ambulatory treatment regimen was associated with an estimated 87.6% reduction in hospitalization and 74.9% reduction in death (p<0.0001).
The authors of this study have taken heat for doing what they signed up for doing as a doctor—following the Hippocratic oath and practicing medicine.
But particularly at the onset of the pandemic, they discussed among themselves the confusion among even the most elite of research institutions, the lengthy and in some cases irrelevant research funded with in hundreds of millions of dollars juxtaposed to the tens of thousands that were dying—in the aggregate, over 560,000 have passed away due to COVID-19.
Care for the Patient: An Important Priority
These healthcare providers were concerned that during the two study periods associated with this case series (April to September 2020 and September to December 2020) that doing nothing while vaccines were under development was not good medicine.
They felt they had a duty to look at studies around the world and find pathways that led to less death. While there are still no authorized drugs for ambulatory care (remdesivir requires hospitalization and monoclonal antibodies must be administered in clinical setting), and unfortunately no deemed conclusive randomized trials of multidrug therapy to help doctors, in this, and all serious medical conditions, the authors emphasize the historically significant and relevant role for empiric treatment in an attempt to reduce fatalities concluded the study authors.
Thus, the doctors’ methodical oversight of a total of 869 patient cases with by comparison striking results.
Could the outcomes here be the result of selection bias? That’s one of the common arguments to challenge this type of study. But the argument here is not that the regimens included in this case series—-ivermectin and doxycycline for example—are established evidence based on this study. That’s not the point.
The authors, rather, in keeping to the Hippocratic oath, organized a study that would generate real world data and the clinical outcomes associated with an empiric multidrug regimen for confirmed COVID-19 patients presenting in the practices of the physicians in this part of Texas.
- Brian Procter, MD
- Casey Ross
- Vanessa Pickard,PA-C, MPAS
- Erica Smith,PA-C,MPAS
- Cortney Hanson, PA-C, MPAS
- Peter A. McCullough, MD