How Vault Helped Run a Convenient and Successful COVID-19 Immunity Clinical Trial

Since our inception, Vault has connected patients nationwide with cutting-edge treatments and virtual visits with experienced and dedicated practitioners. After the pandemic hit, we expanded our services to offer at-home and in-person COVID testing and to help states administer life-saving COVID vaccinations.

During this difficult and uncertain time, we’re proud to have leveraged our technology to distribute innovative and efficient healthcare solutions broadly and at scale, especially when needed most. Now, we’re using our state-of-the-art technology and experience in virtual care to simplify the execution of decentralized clinical trials and provide the utmost patient experience.

Our Clinical Trial Partnership with Rutgers University

We’ve joined forces with Rutgers University to conduct a clinical trial for potential COVID-19 immunity. As one of the United States’ leading research universities, Rutgers was the first partner we trusted to lead the way with this study. They have some of the top talented resources in medicine and are paving the path to huge breakthroughs in healthcare.

The study, called Live Microbials to Boost Anti-SARS-CoV-2 Immunity Clinical Trial (Live BASIC Trial), is investigating the potential of specific probiotics to increase immune protection against COVID-19. Specifically, the study is determining whether a combination of specific probiotics known as OL-1 (which, on a molecular level, resemble parts of the SARS-CoV-2 coronavirus) could be effective in boosting the immune response against COVID-19.

This Live BASIC trial is the first of many clinical studies due in part to our longstanding partnership with Rutgers University to combat COVID-19 through testing.

How We Helped to Recruit Candidates and Gather Meaningful Data

While Rutgers University has taken on the probiotic and sample testing, we at Vault have handled recruitment, logistical planning and coordination for study subjects. At the start of the trial, we successfully recruited 54 people to participate over six weeks. The participants were then divided into three groups, receiving either a high-dose or standard dose of OL-1 probiotic supplements, or an inactive placebo.

To maximize convenience and flexibility, our virtual infrastructure enabled study subjects to participate in the trial from the safety and comfort of their own homes, taking supplements daily and providing biological samples through mail and via brief, COVID-safe home visits by clinical trial staff. There was no travel required, no cost to take part, and participants were compensated for their time. We also connected participants with researchers virtually online and kept journals of any symptoms they were experiencing during the trial.

The Results So Far

The biological samples provided by trial participants are currently being analyzed to determine whether any measurable immune system benefits, such as improved antibody levels, appear to result from OL-1 probiotic supplementation.

If OL-1 probiotics show efficacy in boosting COVID-19 immunity among the population in the Live BASIC Trial, further research may be warranted to determine whether the microbes have wider application in other groups.

What Trial Participants Have To Say

We’re committed to creating a seamless and appealing home-based clinical trial experience for all study participants.

Here’s what current participants have to say about their experience:

“This trial has been smooth from the beginning.”

“Study instructions and procedures have continuously been clear.”

“Consultations with the nurse coordinator from Vault Health have been excellent and have made participation easy.”

“The timeline made out for me was super helpful and a deciding factor in my saying yes to the study.”

“I felt the study was very easy, no pressure. The nurses who came to my home were extremely nice. I would gladly do it again. And the good thing is it was right in my own home and at my convenience. It was a good feeling to know that I could help in this fight against COVID-19.”

Our modular approach tailored to the participants’ needs enables us to power rapid and seamless clinical trials. With our platform, clinical practice, and expertise, we can help organizations build faster and more efficient trials suited for the post-pandemic participant population.

Visit this page to read the whitepaper and learn more about our partnership with Rutgers University.

DISCLAIMER: This article is for general information purposes only, does not constitute medical advice and is not intended to be relied upon for medical diagnosis or treatment. If you are experiencing a medical emergency, dial 911 immediately.