India’s national research organization known as the Indian Council of Medical Research (ICMR) is now reviewing the benefits of ivermectin and doxycycline as a potential therapy for COVID-19. The combination was tested by Dr. Tarek Alam at the Bangladesh Medical College who interviewed with TrialSite News. Hailed as “astounding results” in the hospital approved off-label protocol study of 60 patients, they have all recovered. This got the attention of the national research agency in India.
The interest in ivermectin accelerates worldwide now as the world’s second most populous country’s elite national research agency, ICMR, investigates the U.S. Food and Drug Administration (FDA)-approved anti-parasite drug. Nivedita Gupta, senior scientist with ICMR, reports, “We are closely studying the drug ivermectin and its possible efficacy against COVID-19. It needs to be studied more closely,” reports The Print in India.
The Bangladesh Medical College
As TrialSite News reported in its interview with Dr. Tarek Alam, the Bangladesh Medical College approved an off-label protocol to treat sick COVID-19 patients with the ivermectin and Doxycycline combination yielding “astounding results.” Dr. Alam reported that although the results were clearly beneficial to dozens of patients (n=60), he still acknowledged that a randomized controlled trial would be required to substantiate the mounting evidence from these off-label hospital approved efforts. He reported that Bangladesh Medical College approved his effort that includes the ivermectin 200 mcg/kg once orally with Doxycycline.
Dr. Alam was inspired by the Monash University study showing the ivermectin zapped COVID-19 in a cell culture in a lab setting. With a known safety profile (ivermectin has been around for decades), he mentioned that there is a push at Bangladesh Medical College to launch a full clinical trial with approval from the Bangladesh Directorate General of Drug Administration (DGDA). This is apparently in the planning stages.
ICMR Starts Ivermectin Investigation
Now the ICMR is carefully looking into ivermectin. Ms. Gupta reports that “In in-vitro studies, it has shown effectiveness but there are no studies on human beings” she said. She continued, “We are continuously studying the evolution of the use of this drug in the treatment protocol of COVID-19 patients. However, we need solid evidence or a published study, backed by statistically significant data on a bigger sample size to conclude anything.”
Ivermectin Momentum & Need for Patient Registry
Ms. Gupta doesn’t need to look to far. There are currently at least 18 randomized controlled studies now planned or ongoing that have been disclosed to the U.S. government. TrialSite News has been at the forefront of tracking, monitoring, and reporting on ivermectin and COVID-19 studies.
These studies are led by investigators from Egypt, Iraq, Mexico, Argentina, Brazil, India and the United States (University of Kentucky and Johns Hopkins University). Moreover we are privy to hundreds of cases where ivermectin has in fact worked and patients are around to talk about it.
TrialSite News reported on an innovative doctor in the U.S. who is working on reporting his findings and others are going to publish soon. In Peru, ivermectin is now approved for at least mild cases of COVID-19 and in Bolivia ivermectin is approved at least in the northeaster Beni region. Those approvals were not based on data derived from randomized controlled trials.
Moreover the Australian team that conducted the breakthrough lab study recently received funds from the Helmsley Charitable Trust to advance ivermectin targeting COVID-19.
Ivermectin is being used a treatment against COVID-19 throughout Latin America. Moreover, a major university in a major East African nation, approached TrialSite News to facilitate a meeting with Dr. Alam as this university seeks to sponsor a major clinical trial. ICMR’s position is the right one—there is still no conclusive evidence that ivermectin works until more of this data is aggregated, analyzed, and presented to the world for critical review. TrialSite News has proposed an ivermectin/COVID-19 patient registry.
India’s ICMR is one of the oldest regulatory bodies in the world. Based in New Delhi, it is the apex body in the world’s second most populated country and seventh largest economy as measured by GDP, for the formulation, coordinatio and promotion of biomedical research.