Vault Health published a white paper detailing one of its first active clinical trials. The Live BASIC Trial is studying whether a combination of specific probiotics can help increase immune protection against COVID-19. The pilot clinical trial is being done in partnership with Rutgers University, which Vault has worked with throughout the course of the pandemic through its national COVID testing efforts.
“Probiotics are already thought to have a variety of health benefits. But one specific subset of probiotics – called OL-1 – may have an especially critical role in the fight against the global COVID-19 pandemic,” said Hady Khoury, President of Vault’s Life Sciences division and Chief Research Officer. “That’s because at a molecular level, OL-1 probiotics resemble parts of the SARS-CoV-2 coronavirus that causes COVID-19.”
Khoury says the trial will hopefully shed light on whether that resemblance might coax the body to mount an immune response helpful in warding off COVID-19.
To test that hypothesis, Vault Health successfully recruited 54 people to participate in the research study over six weeks. Some participants were recruited from Vault’s existing patients, while others were recruited through paid marketing. All participants had been infected with COVID-19 in the past and were not vaccinated against the virus. The participants were divided into three groups; one receiving a high dose of OL-1 probiotic, one receiving a standard dose, and one receiving an inactive placebo.
Study subjects could participate in the Live BASIC Trial conveniently from the safety and comfort of their own homes. In addition to taking the probiotics or placebo, subjects provided biological samples by mail and via brief, COVID-safe home visits by Vault’s clinical trial staff. They also connected with researchers virtually and reported any symptoms they experienced through an online questionnaire. All study subjects were compensated for their participation.
The biological samples provided by trial participants are being analyzed to determine whether the OL-1 probiotics led to any measurable immune system benefits, such as improved antibody levels.
“We are eager to see the results of this study,” said lead investigator, Daniel B. Horton, MD, Assistant Professor of Pediatrics at Rutgers Robert Wood Johnson Medical School and Assistant Professor of Epidemiology at Rutgers School of Public Health. “While this pilot study is too small to say anything definite about whether OL-1 could prevent COVID-19, it may provide early clues about the influence of OL-1 on COVID-19-related immunity. This information will be essential to designing larger, more definitive studies.”
Live BASIC Trial one of many, as Vault Health enters clinical research space
The partnership with Rutgers on the Live BASIC Trial is one of nearly a dozen active clinical trials Vault Health is engaged with. For this trial, Vault led the patient recruitment, logistical planning, coordination for study subjects, and in-home clinical visits.
Jason Feldman, CEO and co-founder of Vault Health, says the trial is a great example of how Vault is truly leading the way on a shift towards virtual trials.
“The industry describes it as ‘decentralized clinical research,” said Feldman. “It’s a more technical way of describing the ability to participate in clinical trials without having to drive to a lab and spend hours in-person. The traditional approach to clinical research simply doesn’t provide what we need when it comes to innovating new therapies and treatments.
“The ability to participate in a clinical trial virtually, or through at-home visits with clinical staff breaks down boundaries to participation,” continued Feldman. “It enables researchers to cast a wider net in the first place, which increases the pool of potential clinical study participants, building a more diverse, representative cohort.”
Since the start of the pandemic, Vault has sold more than ten million COVID tests nationally and administered more than half a million vaccines. As the company continues to find ways to leverage its virtual platform and network of more than 750 medical providers across the country, it is now looking to expand its role in healthcare through its Life Sciences division. The company is partnering with sponsors and service providers to build faster and more efficient clinical research.
“The COVID pandemic really accelerated and cemented the prevalence of virtual trials,” said Feldman. “We always knew virtual trials were the way of the future, but when COVID hit, thousands of clinical studies came to a halt, challenging the ability to conduct research safely and efficiently. The FDA’s guidance on alternatives for data collection, sample collection, and site visits is truly changing the landscape of clinical research for the better.”
Vault recently joined the Decentralized Trials and Research (DTRA) Alliance, which includes more than one hundred life sciences and healthcare organizations seeking to accelerate the broad adoption of patient-focused, decentralized clinical trials and research. The alliance was launched in December 2020 with a singular mission to make clinical trial participation widely accessible by advancing policies, research practices, and new technologies in decentralized clinical research.