Patients in East Texas with COVID-19 will begin a clinical trial that could prevent serious illness and death.
This week, 500 hospitalized adults nationwide who have COVID-19 symptoms will be enrolled into the clinical trial. To qualify for the trial, the patient must have symptoms for 12 days or fewer, and must not have life-threatening organ dysfunction or failure.
CHRISTUS Good Shepherd Health System is now one of 50 health organizations around the world to participate in a National Institutes of Health clinical trial to test the safety, tolerability and efficacy of a combination treatment regimen for COVID-19.
The regimen consists of the antiviral medicine which is administered via injection to the vein, along with anti-coronavirus hyperimmune intravenous immunoglobulin, or hIVIG, which are highly purified and concentrated antibodies derived from plasma donated by patients who have recovered from COVID-19. These antibodies have been shown in laboratory studies to neutralize the virus that causes COVID-19.
“Our Research Institute is continuing to lead regional efforts to research novel treatment options for COVID-19,” said Pukar Ratti, system director for Research and Academics.
“We are thrilled to be the only area hospital to offer our patients the opportunity to participate in the clinical trial of this investigational blood-based therapy.”
“This trial will help determine if combining this investigational drug with remdesivir can help stamp out the virus in the early stages of COVID-19,” said Sreenath Meegada, M.D., CHRISTUS Trinity Clinic hospitalist and principal investigator for CHRISTUS Good Shepherd.
The participants are being randomly assigned to receive back-to-back infusions of either plasma donated by patients who have recovered from COVID-19 and the antiviral medicine injection, or a placebo and the anti-viral medicine injection. Neither the participants nor the study team will know who is receiving which treatment regimen until the end of the trial. The study participants will be followed for 28 days.
“The hope is by giving patients anti-coronavirus hIVIG at the onset of symptoms, it will augment the body’s natural response to the virus, thereby reducing the risk of more serious illness and death,” Meegada said.
“We are proud that CHRISTUS Good Shepherd is taking a leading role in what is truly an international effort to fight the COVID-19 pandemic,” said Todd Hancock, Chief Executive Officer, CHRISTUS Good Shepherd Health System.
The clinical trial is currently in phase 3, which is the stage that primarily tests the safety and effectiveness of a drug by studying different populations and different dosages. The data gathered from this phase of the trial is what regulators usually rely on for approval decisions.