Max Healthcare, a modern hospital chain in India, was founded to offer integrated, high-end “unparalleled” health care services. With 14 hospitals, the group recently merged with KKR-backed Radiant Life Care and has entered the research war against SARS-CoV-2, the virus behind the COVID-19 pandemic. After contemplating the latest World Health Organization (WHO) recommendations for COVID-19, Max Healthcare now investigates the use of Ivermectin based on the research of Leon Caly and colleagues in Australia. The worldwide interest to investigate ivermectin as a potentially low-cost and effective COVID-19 treatment gains momentum. Max Healthcare represents the latest data point.
There are currently no specific treatments for COVID-19 other than the emergency approval of remdesivir authorized by the U.S. Food and Drug Administration at the beginning of May.
The World Health Organization (WHO) presently recommends the following investigational treatments for COVID-19, including 1) Remdesivir, 2) Lopinavir/Ritonavir, 3) Lopinavir/Ritonavir with interferon beta-1a, and 4) chloroquine or hydroxychloroquine. Presently there are dozens of studies evaluating these treatments and others. In total, there are now over 249 COVID-19 based clinical trials ongoing.
Australian Research Breakthrough Leads Researchers to Wonder
TrialSite News first reported on Leon Caly and team’s findings that ivermectin absolutely zaps COVID-19 in a cell culture in the lab back on April 5, 2020. Our publishing of the findings from the Peter Doherty Institute (University of Melbourne) and Monash University drove hundreds of thousands of readers to the site. The response and interest was overwhelming—and we received hundreds of requests by readers to pursue the topic. Many others have as well. TrialSite News started following a number of universities and companies around the world that launched ivermectin research initiatives from Iraq and Egypt to Argentina, France and the United States to Japan.
They all found the Australian research finding fascinating—that the FDA-approved anti-parasitic previously shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2) with a single addition to vero-hSLAM cells two hours post infection with SARS-CoV-2 able to effect 5000-fold reduction in viral RNA by 48 hours! Many research centers, biotech and pharma companies, and others interested in research contemplated given that there truly is no real answer to fight COVID-19 yet: “doesn’t this warrant further investigation for possible benefits in humans?”
The Pandemic & India
India is the world’s second most populated country at 1.35 billion and seventh largest economy at 2.7 trillion. Geopolitically a very important place: nearing 100,000 COVID-19 cases and approaching 3,000 deaths, health authorities grow increasingly uneasy in what actually is one of the oldest civilizations on the planet that in just a matter of decades transformed itself into one of the world’s largest economies. India just surpassed China in total COVID-19 cases. With large concentrated population densities, social distancing measures, for example, can be tricky.
On the one hand, the government uses lockdowns, testing and contact tracing in an attempt to control the spread of the virus—hence avoiding the scale of the death toll of the U.S. or Italy or worse. On the other hand, the authorities there understand they must now incrementally open up India’s economy or risk economic calamity and potential upheaval. This is no trivial matter. India’s economy has helped hundreds of millions out of poverty. But according to some figures, two-thirds of India’s population still lives in poverty and hence a prolonged lock-down can lead to economically-driven social impacts of unprecedented proportions.
The Max Healthcare Ivermectin Study
Launched toward the end of April, the study runs through July of this year. Max Healthcare clinical investigators, led by Sandeep Budhiraja, MRCP, FACP, seek to confirm the antivirus effectiveness of ivermectin on COVID-19 as well as explore its potential use in the combating to the COVID-19 pandemic. Enrollment of subjects into this pilot study occur only after strict adherence to informed consent rules—a particularly sensitive topic in India since a Supreme Court ruling against aggressive clinical trials practices of the past.
Titled “Study the Effectiveness of Ivermectin with Standard of Care Treatment Versus Standard of Care Treatment for COVID 19 Cases. A Pilot Study,” Max Healthcare researchers established a pilot study protocol targeting 50 COVID-19 patient cases into two arms.
First, one group of 25 confirmed COVID-19 cases will be treated with ivermectin—200 to 400 mcg kg body weight—on day 1 and day 2 along with standard of care based on the hospital protocol at Max Super Specialty Hospital, Sakent. The second group of 25 confirmed cases will be treated with standard treatment based on the hospital’s protocol. Participants in both groups will be followed up for recovery with regular monitoring.
The monitoring schedule is as follows: 1) test for the virus at 1, 3 & 5 days from beginning of trial drug started for the patient in the hospital; 2) clinical profile of the patient every day of hospitalization 3) investigation of pulmonary function and oxygen saturation daily while hospitalized; 4) the day patient on ventilator and the day removed from the device; and 5) the day a patient develops acute respiratory syndrome and the day when relieved.
The study’s primary outcome measure centers on the effect of ivermectin on the eradication of the virus in a three-month time frame.
The study is conducted at the Max Super Specialty Hospital, Saket (unit of the Devki Devi foundation) considered one of the top hospitals in Delhi. The 500+ bed provider offers treatment across all medical disciplines and state-of-the-art medical technology.
Now led by Abhay Soi, Max Healthcare, a leading hospital system in India, was founded as Max India Limited back in 1985. The first Max Healthcare center was opened in New Delhi in 2000 and it evolved to become an Indian hospital chain. Max India and Max Healthcare merged in 2019. Also in 2019, Radiant Life Care, backed by U.S. private equity firm KKR, bought a 49.7% stake in Max Healthcare. Previously, KKR had invested US$200 million for a 49% stake in Radian in 2017.
Representing one of India’s leading providers of comprehensive and integrated care, a network of 14 hospitals cover the range of specialties backed by over 2,300 physicians with international levels of expertise. Their hospitals are NABH and ISO accredited.
Sandeep Budhiraja, MRCP, FACP, Group Medical Director
Ram Shankar Mishra, DNB, FRCPSource: ClinicalTrials.gov