Houston Methodist Researchers Step Up and Face the Challenges of COVID-19 Virus

Houston Methodist Researchers Step Up and Face the Challenges of the COVID-19 Virus

When the COVID-19 pandemic arrived, although the scientific and medical communities had limited information about how to treat people infected with the novel virus, Houston Methodist was well positioned to meet the urgent need for diagnostics, treatments, vaccines and critical medical technologies.

Throughout the pandemic, our research groups continued their studies without interruption. In fact, Houston Methodist researchers submitted 32 more funding proposals during 2020 than they did the previous year. Many investigators quickly pivoted their research focus to COVID-19-related challenges by participating in more than 50 preclinical studies and clinical trials that resulted in more than 170 COVID-19-related published journal articles and 16,000 media placements.

Houston Methodist Leads the Way in Treating COVID-19 Patients with Innovative Therapies that Boost the Recovery Process

Houston Methodist was the first academic medical center in the nation to receive FDA approval to treat critically ill COVID-19 patients with convalescent plasma therapy — a plasma transfusion from a recovered individual that contains antibodies against the virus.

Eric Salazar, MD, PhD James M. Musser, MD, PhD Although some other organizations had suboptimal results with this treatment, our patients benefited from it because we carefully analyzed and optimized our processes to select the patient populations that would be the optimal candidates. Other institutions treated broad populations much less likely to respond to Houston Methodist’s type of treatment.

In anticipation of the FDA issuing regulatory guidelines, assistant professor in the Department of Pathology and Genomic Medicine, Eric Salazar, MD, PhD, and James M. Musser, MD, PhD, Fondren Presidential Distinguished Chair, developed the therapy protocol. They were the first group in the nation to publish data demonstrating that the therapy is safe and effective. Their work rapidly resulted in five high-profile, peer-reviewed publications on convalescent plasma donors and recipients.

There is so much to be learned about this disease while it’s occurring. If an infusion of convalescent serum can help save the life of a critically ill patient, then applying the full resources of our blood bank, our expert faculty and our academic medical center is incredibly worthwhile and important to do. ”

Research

Houston Methodist’s Participation in Clinical Trials for Innovative COVID-19 Treatments Has Aided Many Patients’ Recoveries

Considered the next evolution of plasma therapy, monoclonal antibody, or mAb, therapies contain synthetic versions of the proteins made by the immune system to neutralize the virus. The mAbs are designed to bind to key sites on the virus molecule to prevent it from attaching to and infecting human cells.

A team of experts at Houston Methodist, led by Salazar, began participating in the clinical trials in hospitalized patients determining the safety and effectiveness of the combination mAb therapy from Regeneron containing two neutralizing mAbs called casirivimab and imdevimab in July 2020. Current data from the Regeneron REGN-COV2 trial show that trial participants receiving the experimental therapy had a lower risk of death or need for mechanical ventilation than those in the placebo group.

Houston Methodist is also actively involved in the clinical studies investigating how well Eli Lilly’s bamlanivimab, a mAb therapy similar to Regeneron’s cocktail, safely and effectively prevents mild COVID-19 infections from becoming more serious. Clinical trial lead Howard Huang, MD, interim chief, division of pulmonary, critical care and sleep medicine, and his teams are administering a single intravenous infusion of the drug to patients who have recently received a positive COVID-19 test and show mild to moderate symptoms in the hopes of intervening before patients have a chance to develop more serious symptoms, thereby reducing COVID-19-related hospitalizations and emergency department visits. Huang and his team are also involved in similar studies of the Regeneron mAbs in patients with mild to moderate symptoms.

In November, the FDA issued an emergency use authorization for both the Regeneron and Eli Lilly therapies for treating mild to moderate COVID-19 infections in patients who are at high risk of becoming dangerously ill. The quick progression from beginning investigational clinical studies on newly developed drugs to having the ability to treat patients not involved in a study is a prime example of translational research in action. Houston Methodist Played a Key Role in Establishing Remdesivir as a Standard of Care for Treating COVID-19

In mid-March of 2020, Houston Methodist became the only clinical trial site in Houston and the fifth site in the nation to join the two global phase III clinical trials evaluating Gilead Sciences antiviral drug Remdesivir in patients hospitalized with moderate or severe COVID-19 infections. Originally developed to treat Ebola, Remdesivir blocks the SARS-CoV-2 virus’s ability to quickly replicate throughout the body, neutralizing the deadly inflammatory cascade that leads to respiratory failure and dependence on a ventilator.

The Houston Methodist clinical study led by Katherine Perez, PharmD, assistant professor of allied health sciences, Department of Pharmacy, Department of Pathology and Genomic Medicine and Kevin Grimes, MD, assistant professor of clinical medicine, Department of Medicine, found that participants with COVID-19 responded quickly to the investigational drug and recovered more quickly than their control counterparts. The final report from the global trial leadership confirmed that Remdesivir shortens the time to recovery in adults hospitalized with COVID-19, which paved the way for Remdesivir to become the first antiviral treatment approved by the FDA for COVID-19.