University of Texas Health Science Center at Houston

“This is how we can help” – Couple shares their story as COVID-19 clinical trial participants

Newswise — “I don’t feel so great,” my husband, Brandon, said to me one Saturday afternoon – the last thing I wanted to hear after spending the last seven months tuned into COVID-19 media coverage. Knowing a few of his co-workers had recently tested positive for the virus, we didn’t wait to secure an appointment for a rapid test. When he called me an hour later to tell me he has tested positive, my heart sank.

It is hard to put into words how frightening it is when the very thing you’ve avoided for the better half of a year finds its way into your home. However, as a media relations specialist covering both infectious diseases and public health at The University of Texas Health Science Center at Houston (UTHealth), I was thankfully armed with knowledge from some of the world’s leading experts on the front lines of the pandemic. I’ve been in daily communication with researchers and physicians about the latest findings on this virus, trying to get critical health information out to the public. But now it was time to put that knowledge into action for myself and my husband.

The following morning, I still did not feel any of the usual symptoms – no fever or body aches, and my sense of smell and taste were both still intact. I made an appointment to be tested that afternoon so I could know my status for peace of mind. I tested negative, so we continued to quarantine apart in our home.

Recently, I had been working with a research team to educate the public about two clinical trials testing the effectiveness of monoclonal antibodies. It dawned on me – we were each qualified candidates for one of these studies. Brandon fit the requirements for ACTIV-2, a study on multiple treatments, including a monoclonal (laboratory-made) antibody, at preventing mild COVID-19 from advancing to severe illness in the outpatient setting. While I was not positive for COVID-19, I met the criteria for the REGN-COV2 trial, studying if a combination antibody treatment can prevent COVID-19 illness in individuals who live with someone with the virus.

We called the research hotline, and when I shared I was actually reaching out to make an appointment to assess us for these two studies, I had to laugh. “The irony of this is not lost on me,” I said.

I arrived the following morning at Harris Health System’s Lyndon B. Johnson Hospital to be assessed for the REGN-COV2 trial. My second COVID-19 test in 24 hours was conducted, and lab results confirmed I was still negative. I was randomized and by that evening, I was the first local patient to be enrolled in the study and receive four injections of either the trial agent, an antibody cocktail that targets two different sites of the spike protein found on the surface of the coronavirus SARS-CoV-2, or a placebo.

On Tuesday, Brandon made his way to Harris Health LBJ to receive his infusion of either LY-CoV555, an investigational monoclonal antibody developed from the blood sample of a recovered COVID-19 patient, or a placebo.

Since both trials are blinded, there’s no way of knowing which we received. However, we closely monitored our symptoms, and Brandon is required to keep a symptom log for the first month. Each night he swabs his nose, measures his temperature, and writes down any symptoms he had or medications he took that day. He also has his blood drawn weekly for the first month post-infusion to monitor his body’s response to the treatment agent.

For my trial, I attended weekly follow-up appointments for the first month to measure my vitals and conduct a COVID-19 test.

By week four, I am still COVID-19 negative. Brandon has made a full recovery, and his sense of smell and taste have returned – which was evident when I burned some muffins and hoped he would eat the rest of the batch without complaint. (He did not.)

In a time when all eyes are on research in the search for a COVID-19 therapy or cure, I was grateful that both my husband and I could help. I am surprised at how simple it was to contribute to this worldwide effort. Just a few hours of our time, some bloodwork, and several COVID-19 nasal swabs later, we can both say we have done our part.

The study team was grateful too, since having two participants from one household means we could support one another throughout the steps of our trials, and help maintain communication with the study team.

“In addition, having two participants from a household enables one person's illness to contribute to the efforts to find both therapeutic and preventative agents. If the participants happen to receive the active agents and they turn out to be effective, the participants may also derive some benefit,” said Netanya S. Utay, MD, a study co-investigator and an associate professor of internal medicine at McGovern Medical School.

The experience gave me a chance to witness firsthand how passionate the team of infectious disease researchers at McGovern Medical School are, not only in the treatment of their patients, but for using their expertise in the search for a medication that will hopefully help so many affected by this illness.

Both trials are actively enrolling participants. Those who may qualify for the ACTIV-2 trial can enroll at Harris Health LBJ or the UTHealth Clinical Research Unit at Memorial Hermann-Texas Medical Center. The REGN-COV2 trial is open to participants at Harris Health LBJ.

“The more people participate in clinical trials to help us figure out which agents work, the sooner safe, effective agents will be available for everyone.  Without study volunteers, we will never have confidence in which agents work,” Utay said.

For more information about the ACTIV-2 trial, please visit the study website.

Regeneron Pharmaceuticals is sponsoring the REGN-COV2 trial clinical trial. For more information on that study, visit ClinLife.com or ClinicalTrials.gov.




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