COVID-19 Therapy Studies | Remington-Davis

Amid the COVID-19 shutdown in early 2020, hospitals quickly became inundated with acute COVID-19 patient care. As emergency rooms and ICUs faced unprecedented volumes, they set up overflow command centers in public spaces to provide patients with life-saving care.

The majority of clinical research related to the management of chronic conditions came to a screeching halt. These studies were quickly replaced with COVID-19 treatment trials and COVID-19 vaccine trials. In addition to finding new treatment options for hospitalized patients with COVID-19, clinical trials began to focus on overall public health and individuals who were symptomatic and positive but not yet acutely ill. The goal was two-fold: prevent their condition from progressing to acute illness requiring hospitalization and reduce strain on the already overburdened healthcare system.

Remington-Davis (RDI) stood ready to answer the call. Combining more than 30 years of clinical research experience, RDI was able to reallocate resources and quickly build an infrastructure necessary to meet the unique infection control needs of the global pandemic.

Several biotech and pharmaceutical companies asked for RDI’s support in conducting COVID-19 outpatient treatment and prevention trials. Collectively, RDI served five different pharmaceutical and biotechnology sponsors over the course of nine months.

Biotech & Pharmaceutical Companies

Five sponsors

in the span of nine months

The Clinical Trial Focus

Monoclonal antibodies and anti-virals for COVID-19

How RDI Offered Support

Quickly set up additional clinic space to support trials
Supported enrollment with innovative strategies and patient-centric experiences
Delivered flexibility to meet capacity, technology and supply chain needs

Taking Quick Action to Get Trials Up & Running

After consulting with the building owners of their 5,000 square-foot facility, RDI was able to set up a short-term lease for use of a space on the other side of the building. An independent COVID research clinic (CRC) was equipped with six IV infusion rooms where staff could administer investigational drugs, process labs and manage study patients. Home-like accommodations created a comfortable space for patients to spend time as they awaited test results, received infusion therapies, and remained under observation to ensure no reactions had occurred.

From a staffing standpoint, RDI was able to quickly find qualified infusion nurses that were willing to work with RDI on a part-time basis. The clinic staff wore full PPE to comply with safety standards throughout the trial.

All and all, it took 30 days from the first study offer to the opening of the CRC.

A Deeper Dive Into Trial Dynamics

Each trial intended to serve a different niche population related to COVID-19. These populations included active symptoms without risk factors for severe disease, active symptoms with risk factors for severe disease, active infection without any symptoms and household exposure without infection or symptoms.

Different modes of therapy were also employed: IV infusion, sub-Q injection and nasal drops depending on the trial. All studies incorporated the use of monoclonal antibodies and/or anti-virals.

Each study started the clock for participation in a different way. Examples were the number of days from exposure, the number of days from first symptom onset and the number of days from first positive test. The clocks were all ticking at different rates and based on different criteria; but once the clock expired, a patient was no longer eligible to participate in the clinical trial and the chance to enroll and uncover solutions was lost.

Enrolling Patients Into the Studies

When it came to advertising these studies, RDI had to think outside the box and take big steps to reach the entire Central Ohio community. Anyone could become a potential study patient at any time. RDI created yard signs that asked, "Are you COVID positive?” and encouraged individuals to join the trial. For maximum visibility, these signs were placed adjacent to drive-thru testing centers. RDI also positioned billboard ads at busy intersections, as well as adjacent to medical facilities and testing locations.

At the same time, RDI started paying attention to cluster areas where people were getting COVID, for instance, sororities and fraternities on The Ohio State University campus. RDI would leave approved recruitment materials in a bag on the front steps of their respective houses. The student population represented generally healthy individuals and while in quarantine for campus activities, a trip to the CRC was often the only opportunity that students had to leave their designated quarantine space.

While these were placebo-controlled studies, many participants were incentivized by the idea of helping future generations or future COVID patients while possibly decreasing the severity of their own COVID-19 illness. And the numbers reflect that: between July 2020 and February 2021, RDI saw 236 COVID patients in the CRC.

Driven by the possibility of finding an effective therapy for COVID and the positive experiences within the clinic, RDI found that study participants were happy to refer their housemates, families and friends to the studies as well. In fact, a cluster of 16 patients in one study all stemmed from a single participant.

RDI Delivers Flexibility Where It’s Needed

If a patient contacted RDI about entering the COVID-19 trial and their eligibility clock was running out, RDI found a way to get them on the schedule that same day. That translated into long days where staff would see anywhere between 25 to 35 patients in the clinic. Flexible times and hours, paired with comprehensive resources, enabled RDI to keep up with extraordinary demand.

Some patients were immunocompromised or had cancer and were desperate for treatment, traveling from neighboring states to participate in studies. RDI stayed late into the evenings and on weekends to accommodate all patients, especially those that were chronically ill.

Meanwhile, because study sponsors couldn’t send people to RDI to review paper data, RDI had to implement eSource alongside the infrastructure, platform and hardware to support its use. RDI was able to overcome this technical challenge and use RealTime’s eSource platform for the first time.

Throughout the duration of the trials, there were some cases where it made more sense to conduct home visits with patients to capture data versus asking them to come into the clinic. If a study participant wasn’t feeling well, an RDI staff member could travel to their home to take swabs or blood draws.

The other layer to all this was navigating supply chain challenges. In a time when getting lab kits and other medical supplies proved difficult, RDI found workarounds. RDI worked closely with support teams in labs to work through minimum requirements to ensure the necessary supplies were available in time for studies. Rather than waiting for pre-packaged lab kits to arrive, RDI liaised with central lab vendors to understand the requirement and build their own kits on-demand.

The Powerful Impact of These Studies

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Several of the monoclonal antibody products that were the focus of RDI trials received approval for emergency use. These emergency options became especially useful in areas with elevated densities of high-risk individuals. Communities around the U.S. with a high population of high-risk elderly patients opened COVID-19 treatment clinics where the Regeneron and Lilly monoclonal antibody therapies approved for emergency use were made available on a walk-in basis.

While far reaching, the monoclonal antibodies’ impact hit close to home. RDI staff saw their own high-risk family members receive emergency use treatment and recover faster and more fully than could have been anticipated.

Although evolving strains of COVID-19 led to the discontinuation of approved emergency use programs, RDI is proud to have made a meaningful contribution amid the public health crisis and helped prevent additional fatalities.

Remington-Davis Helps Get COVID-19 Therapies to Market for Emergency Use