Florida Value-based Medical Practice Launches RCT, Double-Blinded Ivermectin & Doxycycline Clinical Trial in Sarasota

Florida Value-based Medical Practice Launches RCT, Double-Blinded Ivermectin & Doxycycline Clinical Trial in Sarasota TrialsiteN

A west coast Florida-based medical practice called MAXhealth and its affiliated accountable care organization (ACO) management firm Subsero Health recently launched a Phase 4 randomized controlled and double-blinded clinical trial in the State of Florida evaluating the use of Ivermectin and Doxycycline targeting COVID-19 patients.  Known as the COVIVER-OUT PLUS study (“A Randomized Double-blinded Placebo-controlled Outpatient Clinical Trial in High Risk Population Confirmed COVID-19 Patients Using Ivermectin and Doxycycline to Prevent COVID-19 Illness-related Hospitalization”), the study appears to have just started recruiting at the end of January. As mentionedm Subsero Health is an ACO management firm affiliated with MAXHealth, a family practice network with ten locations on the western coast of Florida, offering convenient, affordable primary and specialty care for patients in both Sarasota and Naples, Florida, and surrounding region. The practice specializes in the delivery of value-based care, promoted by Medicare’s move away from fee for services to value-based care. This important Ivermectin study, although not large (150 patients), further evidences the movement for what is known in Bangladesh during the COVID-19 crisis as “the People’s drug.”

The Study

Recently disclosed in clinicaltrials.gov, the COVIVER-OUT PLUS (NCT04729140) study started recently and, based on the disclosure, runs until the end of the year with final data report in early 2022.

The 150 participant double-blinded study includes a combination that’s known as “the people’s medicine” by Dr. Tarek Alam from Bangladesh Medical College in Dhaka, Bangladesh—that is, a combination of Ivermectin and Doxycycline for use targeting COVID-19. Actually involving three (3) arms, the study cohorts include 1) Ivermectin and Doxycycline; 2) Ivermectin and placebo; and 3) Placebo comparator group.

The first Ivermectin and Doxycycline group includes 200 mcg/kg on day 1 and day 2 plus doxycycline 100 mg tablets twice a day for seven days. Like Ivermectin studies around the world, the dosage is based on body weight. The second group includes 200 mcg/kg of Ivermectin on day 1 and day 2 plus placebo tablets twice a day for seven days. Finally, the third group of patients receives two differing placebos.

Targeted Endpoints

The study sponsor’s primary outcome measure includes a decreased admission rate to the hospital secondary to respiratory illness related to COVID-19. The study team will monitor over the study duration of each patient for five weeks.

Secondary measures are numerous—they include 58 in total—and can be viewed here

The Sponsor

This study is sponsored by MAXHealth, a family practice network that offers convenient, affordable primary and specialty care for patients in both Sarasota and Naples, Florida, and the surrounding region. This is in combination with ACO management services firm and affiliated Subsero Health LLC, which was set up to master value-based care contracts as part of the transformation to value-based medicine as manifest in the emergency of Accountable Care Organizations (ACOs). These new entities are in response to the 2015 declaration by the U.S. Department of Health and Human Services (HHS) that 85% of Medicare payments will be linked to performance and value and not the volume of services provided. Given that about half of all Americans consume some form of government subsidized insurance program (Medicare, Medicaid, VA, DOD, HRSA Title V), a huge proportion of reimbursements became subject to change. This Florida-based provider specializes in this area. Its ACO known as Health Point ACO was rated in the top 5% of all ACOs in 2016.

MAXHealth has 10 locations on the western coast of Florida as well as partner medical centers delivering specialized medical care, including dermatology, cardiology and oncology. The overall practice has nearly 50 providers and is approaching 100 employees. The ACO management firm Subsero Health is led by Inita Bedi, MD

Lead Research/Investigator

Werther Marciales, MD, Principal Investigator

Ryan Salom, Sub-Principal Investigator

Faheem Ahmad, MD, Sub-Principal Investigator

Divisha Sharma, MD, Clinical Trial Investigator

Nicholas Guy Ross, DO, Clinical Trial Investigator

Call to Action: This important Phase 4 clinical trial is the second Ivermectin-based study published in the U.S. by a private practice (the first being Progenabiome in Ventura, California led by Dr. Sabine Hazan who has been profiled by TrialSite on Cure Seekers). Other than a couple academic medical centers that announced studies, the other important case series, actually a pathbreaking initiative involving the use of Ivermectin was the ICON study led by Dr. Jean-Jacques Rajter and his wife Juliana Cepelowicz also in Florida at Broward Health. TrialSite will monitor this study.