Recently, TrialSite News reported on a study sponsored in Bangladesh by Upazila Health & Family Planning Officer’s (UHFPO) Office, Chakoria, Cox’ Bazar and Abu Taiub Mohammad Mohiuddin Chowdhury, First Affiliated Hospital Xi’an Jiaotong University. The observational study was conducted from May 2 to June 5, 2020. The principal investigators observed 181 patients who tested positive for COVID-19. The Research team recently shared the results via preprint server and ResearchGate. The study team concluded that concerning the treatment outcome, adverse effect, and safety, the Ivermectin and Doxycycline combination was superior to the use of Hydroxychloroquine and Azithromycin therapy in the case of mild to moderate degree of COVID-19 patients. Although both treatment regimens were observed to be effective for this study, the Ivermectin treatment was superior.
Sponsored by Upazila Health & Family Planning Officer’s (UHFPO) Office, Chakoria, Cox’s Bazar in collaboration with Abu Taiub Mohammad Mohiuddin Chowdhury, First Affiliated Hospital Xi’an Jiaotong University, China, this study was conducted for just over a month from May to June 2020. The investigators observed 181 patients who had tested positive for SARS-CoV-2 infection by RT PCR undertaken at Cox’s Bazar Medical College. The participants were observed carefully for family history and any comorbidities that could disqualify them for this study. As it turned out, 42 participants had comorbid conditions that could impact recovery time; 14 participants were unwilling to participate in the study and 9 participants failed to participate (3 from group A and 6 from group B) for follow up sample collection so these were excluded. Following exclusion, 116 patients were included with mild to moderate degree of illness with normal or near-normal chest radiograph and Oxygen Saturation more than 95% were included in this study. All the patients enrolled in the study were treated as an outpatient protocol.
The study patients were divided into two groups including (A) (n=60): Ivermectin 200 µgm/kg single dose and Doxycycline 100 mg BID for 10 days. Note this is very similar to Dr. Tarek Alam’s successful hospital approved protocol study at the Bangladesh Medical College. Group (B) (n=56): Hydroxychloroquine 400mg first day then 200mg BID for 9 days plus Azithromycin 500mg daily for 5 days.
Standard of Care
Additionally the principal investigators and staff treated the patients with any fever, headache, cough, myalgia, and other complaints. The participants were advised for self-isolation, proper nutrition, hydration and a sanitary environment.
The team evaluated the patients every 2 days starting from the 5th day (Asymptomatic patients) or the 2nd non-symptomatic day from the first day of the drug intake by PCR study or nasopharyngeal and throat swab in each group. Regular contracts were maintained to find out the adverse or side effects of the therapy.
Much like the results from Dr. Rajter at Broward County, Florida, United States and Dr. Tarek Alam, Bangladesh Medical College, the results here were quite positive.
Group A, the Ivermectin group, experienced a 100% recovery rate, with a mean symptomatic recovery duration of 5.93 days and negative PCR was on 8.93 days. The Group B results (Hydroxychloroquine and Azithromycin) was 96.36%, 6.99 days and 9.33 days respectively.
55.10% of the patients in Group A (Ivermectin) gained symptomatic recovery on the 5th day. A mild degree of adverse effect was noted by 31.67% of patients; lethargy in 14 (23.3%), nausea in 11 (18.3%) and occasional vertigo in 7 (11.66%) of patients.
In the meantime, Group B experienced some degree of adverse effects; 13 (23.21%) mild type of blurring of vision and headache; 22 (39.2%) increased lethargy and dizziness, 10 (17.85%) occasional palpitation, and 9 (16.07%) experienced nausea and vomiting.
The Upazila Health & Family Planning Officer’s (UHFPO) Office, Chakoria, Cox’s Bazar in collaboration with Abu Taiub Mohammad Mohiuddin Chowdhury, First Affiliated Hospital Xi’an Jiaotong University in China has come to the conclusion that in regards to treatment outcome, adverse effect and safety, the Ivermectin and Doxycycline combination is superior to Hydroxychloroquine-Azithromycin therapy in the case of mild to moderate degree of COVID-19 patients. The Bangladeshi and Chinese team found that both treatments were effective in this study. However, the Ivermectin results were superior to Hydroxychloroquine.
This controlled observational study in Bangladesh produces some relatively compelling results. Patients tested positive for COVID-19 are taking a combination of Ivermectin and Doxycycline with a 100% success rate. On average, the mean symptomatic recovery was 5.93 days with a disease that can stretch for two to three weeks.
TrialSite News has interviewed Dr. Jean-Jaques Rajter, MD, of Broward County Health who conducted an off-label, county health approved protocol. On June 9th TrialSite News reported on the results: the team found that Ivermectin was associated with lower mortality during treatment of COVID-19 patients in this carefully controlled off label observational study. Interestingly Dr. Rajter hasn’t found too many eager peer review publications to publish the results despite the fact that a major U.S. County Health Board approved the off label use observational study.
Moreover, TrialSite News interviewed Dr. Tarek Alum who reported “astounding results” for the hospital approved protocol at the Bangladesh Medical College.
At the Intersection of COVID-19, Drugs, Money & Power: The Complex
TrialSite News agrees with WHO and the U.S. Food and Drug Administration (FDA) that an important next step for acceptance of Ivermectin as a treatment for COVID-19 would include results from randomized controlled trials. And a number of them have commenced.
One of the at least 31 Ivermectin clinical trials has been completed from the University of Baghdad. Principal Investigator Faiq Gorial is trying to get the study results published. The outcome is not clear yet. Dr.Eli Schwartz, a prominent key opinion leader out of the renowned Sheba Medical Center, will complete an Ivermectin randomized controlled trial by September/October 2020. Dr. Schwartz, a brilliant physician and researcher, has been bullish on the prospect for the anti-parasitic drug targeting the novel coronavirus. The University of Kentucky Ivermectin study is now recruiting while the Johns Hopkins University Ivermectin study for whatever reason appears to still not be recruiting.
But the complete lack of intellectual interest in the Ivermectin movement, including reputable hospital protocol approved, off-label, controlled observational studies, raises suspicions of a set point of view.
That TrialSIte News has spoken with several physicians around the world in combination with outcomes from these carefully run observational studies starts to make the team wonder if there isn’t some institutional bias against this particular alternative approach. There appears to be a strange lack of any intellectual curiosity on the part of the “establishment” we refer to as a pharma-government-academia industrial complex or “complex.”
While intriguing movements such as Ivermectin with growing data points of success are completely ignored, Remdesivir is blindly embraced: although the drug hasn’t really demonstrated success anywhere else (e.g. not for Ebola) and shown only some positive results, they certainly aren’t any better than the apparent Avigan (Favipiravir) results, which have led to approvals targeting COVID-19 in Russia, China and India. Bizarre given the U.S. government injected $138+ million into Favipiravir just eight years ago for the exact scenario that is now unfolding: a global pandemic.
Rather, the “complex” pushes on with remdesivir to the point that no one seemed to mind when standard protocol was ignored when just weeks before the clinical trial’s conclusion, the primary endpoint was literally changed so that the study could still be relevant. The primary outcome measure established in the remdesivir protocol was chucked last minute to save the faith. That bold and seemingly brazen move raised red flags among most critical thinkers. Perhaps that is how much power is now concentrated in “complex” circles.
The world of drug development, involving large biopharmaceutical companies, major academic medical centers, and regulators perhaps becomes too cozy. Over the coming months, TrialSite News will certainly look for chinks in the armor of the “complex.”
Lead Research/Investigator for Bangladesh Study & Jiaotong University Study
- Abu Taiub Mohammed Mohiuddin Chowdhury, MD, First Affiliated Hospital Xi’an Jiaotong University
- Mohammad Shahbaz, MBBS, MCPS, Upazila Health & Family Planning Officer’s (UHFPO) Office, Chakoria, Cox’s Bazar
Call to Action: Consumers and professionals monitoring COVID-19 therapies should look carefully into any subtle, or not so subtle, institutional biases in favor of expensive, more complex treatments over basic, economical treatments that can treat much of the world.