TrialSite News’ interview with Tarek Alam, head of medicine department at Bangladesh Medical College, has led to considerable interest in regional hospital protocol-approved, off-label use of ivermectin and the antibiotic Doxycycline in patients diagnosed with mild cases of COVID-19. Thus far, Dr. Alam reaffirmed to TrialSite News their “outstanding results.” A number of developing economy-based nations are embracing ivermectin as a low-cost approach to fighting at least mild cases of COVID-19—despite the lack of data from randomized controlled trials. Most recently, TrialSite News learned that the government in Peru has accepted Ivermectin as a COVID-19 treatment, and we helped share with the world the fact that Bolivia is handing out up to 350,000 doses of the antiparasitic drug to those with mild COVID-19 symptoms. Hundreds of thousands of readers have visited TrialSite News’ ivermectin articles with hundreds of messages and a number of requests from other nations to make introductions for planned ivermectin research.
The Bangladesh Medical College Interview
Our interview with Dr. Alam was enlightening. By leveraging the TrialSite Investigators Network (a large database of investigators worldwide), TrialSite News managed to get through to Dr. Alam, a wonderfully cordial and supportive doctor dedicated to the healthcare of all. The Dhaka-based physician and professor commented that although some press referred to the effort as a “study” based on TrialSite News’ questioning, it was not a formal regulatory approved study but rather an ongoing, hospital-specific, approved off-label use of medication for some COVID-19 patients with escalating conditions. More specifically, they are combining a dosage of ivermectin 200 mcg/kg once orally with Doxycycline.
Dr. Alam noted that this cannot be declared a cure or a treatment yet; this very important point is not accurately emphasized by other media. He correctly declared what he and his colleagues have observed thus far. He understands the importance and requirement of randomized controlled trials for more specific and forceful claims.
Dr. Alam reports that some of the doctors at his institution are organizing a regulatory approved clinical trial involving the use of ivermectin with COVID-19 patients. TrialSite News monitors the situation for more specifics. The principal drug regulatory agency in Bangladesh is the Directorate General of Drug Administration (DGDA)—it functions under the Ministry of Health and Family Welfare in the national government.
TrialSite News reported that a Bolivian regional government had accepted ivermectin as a treatment for COVID-19—namely in the Beni region and its biggest city Trinidad, where government authorities are now handing out ivermectin—up to 350,000 doses of the drug—to target COVID-19 cases. The New York Times and U.S. World & News Report have also reported on the Bolivian use of ivermectin.
Now Peru has purportedly accepted ivermectin as a COVID-19 treatment. For example, recent proclamations from the Ministry of Health found in an artifact titled, “Prevention, Diagnosis and Treatment of People Affected by COVID-19 in Peru” declares what is acceptable usage of ivermectin in patients with mild COVID-19. Again, this trend unfolds without data from randomly controlled trials—the types of studies typically needed to verify and validate the claims of any particular medicine.
Need for Data
A dearth of systematically collected and analyzed data still represents a challenge. Yes, there are many dedicated, intelligent and committed physicians around the world treating patients with mild COVID-19 off-label with ivermectin. In fact, physicians in the U.S. are also involved, as we have discussed via this platform dedicated to research transparency and accessibility. There are now over a dozen clinical trials that TrialSite News follows from Egypt and Iraq to Argentina, Brazil and Mexico, as well as the United States.
Even the Australian group that catalyzed what could turn into a movement for the possibility of a safe, low-cost treatment for at least mild cases of COVID-19, has received funding from a U.S. philanthropic organization to pursue an optimized ivermectin dosage in anticipation of forthcoming clinical trials.
An Ivermectin COVID-19 Registry?
While awaiting the existing batch of planned ivermectin-focused clinical trials, in parallel with a number of ongoing clinical trials including ivermectin, the world could use a more comprehensive set of ivermectin and COVID-19 patient data. Perhaps this data could be derived from a series of collaborative efforts involving different groups treating patients around the world today. Why not establish an ivermectin registry? There are enough groups we know of treating patients with the antiparasitic drug. TrialSite News would contribute to such an effort with the right partnerships in place.