The investigational interest in common and economical anti-parasitic drug ivermectin (Stromectol) continues to grow now as the prestigious Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins plans to launch a clinical trial in June. In hospitalized patients with SARS-CoV-2, the virus behind the COVID-19 pandemic, the Baltimore, Maryland-based investigators will compare the standard of care with bicalutamide or ivermectin. They are joining a growing group of research centers in a search for effective and safe treatments. This group is taking a noticeably different approach than the University of Kentucky study, which focuses on patients at home with milder cases of COVID-19.
A growing number of research centers around the world are investigating the use of Ivermectin as a potential therapy targeting SARS-CoV-2. The idea started thanks to a group of creative and out-of-the-box thinking scientists in Australia. The word spread and now a number of companies, academic medical centers, and governments are exploring the use of the anti-parasitic drug as a possible therapy. The upside could be huge: the drug is inexpensive and available. In fact, Merck even helps developing nations by giving the drug, called Stromectol, away in some cases. Now Johns Hopkins investigates ivermectin and an anti-androgen drug known as Bicalutamide—used together or with another hormone to treat prostate cancer.
Planned to commence June 2020 for a year, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins will probe into whether bicalutamide or ivermectin can have an impact on hospitalized patients infected with SARS-CoV-2. Led by Principal Investigator Catherine H. Marshall, MD, MPH, and a team of sub-investigators listed below, the team will study two groups including one randomized group receiving Bicalutamide Casodex) 150 mg by mouth daily for seven (7) days versus plus the standard of care for COVID-19 versus the use of versus a study group receiving Ivermectin (Stromectol/Soolantra/Sklice) 600 µg/kg (maximum dose of 60mg) by mouth daily for three days with the possibility of extension to six (6) days if still hospitalized and approved by the Data and Safety Monitoring Board.
Basis for Investigational Medications & Doses & Duration Rational Not Disclosed
The investigators at Johns Hopkins do not provide any rational in their disclosure for why one treatment lasts seven days and the other three days nor the basis for the use of the anti-androgen medication frequently used in prostate cancer cases.
The team’s primary outcome measure focuses on the number of participating patients who show clinical improvement at day 7 post randomization. Their benchmark for measurement includes the World Health Organization (WHO) Ordinal Scale for Clinical Improvement. Again, TrialSite News would seek to understand why the ivermectin treatment is only three days given a seven-day period for observation of primary outcome.
A number of secondary outcomes are scrutinized including mortality rate at 28 days, duration of hospitalization, number of patients that must be upgraded to intermediate care, etc.
Eligible patients must be at least 18 years old with a positive COVID-19 diagnosis via a polymerase chain reaction (PCR) test and require inpatient hospitalization with minimal to no respiratory symptoms. Of course, the patient must be able to provide informed consent. Professor Marshall and team have established a number of exclusion criteria in the protocol that can be reviewed in the source study disclosure.
Catherine H. Marshall, MD, MPH, Principal Investigator
Samuel Denmeade, MD, Sub-Investigator
Vasan Yegnasubramanian, MD, PhD, Sub-Investigator
Shawn Kwatra, MD, Sub-Investigator
Jeffrey Rothstein, MD/PhD, Sub-Investigator
Call to Action: TrialSite News will seek to elicit more information on this interesting study as well as monitor for updates and ultimately conclusions. Sign up for the newsletter for updates.