Bindu Akkanti covid clinical trials
Bindu Akkanti, MD, discusses the benefit of academic medicine after one of her patients, who was enrolled in two clinical trials, recovers from COVID-19. (Photo courtesy of Akkanti)

Heba Hajjar, 23, recovered from COVID-19 after participating in two clinical trials through UTHealth while in the intensive care unit (ICU) at Memorial Hermann-Texas Medical Center.

She was so weak she couldn’t move or sit up in bed. She was cautiously monitored on oxygen therapy and was asked to sleep on her abdomen to keep her oxygen levels up. After a few days, she became critically ill and was on the verge of being placed on the ventilator. As part of ongoing COVID-19 research, she was given a convalescent plasma transfusion.

“The day after receiving the plasma, I asked the nurse if I could try to sit upright in bed, something I hadn’t been able to do for the last several days,” Hajjar said. “So, we tried and I was able to do it, and not long after, I was able to stand up by myself.”

Hajjar was discharged two days after receiving the plasma and physicians were thrilled at her improvement, but they can’t say for sure if the plasma is definitively what helped her – for two reasons.

“We know convalescent plasma is safe but we don’t know if it really works, because no large randomized clinical trials on the treatment have been completed,” said Luis Ostrosky, MD, professor of medicine and epidemiology at McGovern Medical School at UTHealth and medical director for epidemiology at Memorial Hermann-TMC. “A randomized trial is the gold standard of research and has to be done to know for sure if the treatment is effective.”

Ostrosky is part of team at UTHealth that just received more than $8 million from the National Institutes of Health to investigate whether convalescent plasma is effective in COVID-19 patients. The grant funds a randomized, Phase II clinical trial, meaning researchers won’t know if patients received the treatment or placebo.

Hajjar received the convalescent plasma under a UTHealth expanded use research protocol through the Mayo Clinic. Recently, the U.S. Food and Drug Administration announced convalescent plasma would shift to emergency use, meaning the treatment would fall outside the framework of research and more hospitalized patients would have access to the treatment.

“Under emergency use authorization, the treatment does not fall under research but the patient still has to sign to say that they know it is not a proven therapy,” said Ostrosky, vice chair of healthcare quality with McGovern Medical School and an infectious disease specialist at UT Physicians. “It is good in the sense that more patients could have access to treatment, but could also make it harder to conduct the randomized trial for researchers to assess its efficacy.”

The other reason researchers can’t definitively attribute plasma to Hajjar’s recovery is her participation in another clinical trial while in the ICU.

Hajjar enrolled in a UTHealth study in which researchers are investigating whether leronlimab, a monoclonal antibody treatment being investigated for patients with HIV, can help COVID-19 patients. The trial is randomized and blinded, so physicians don’t know for sure if she got the treatment or not.

“Heba’s case really demonstrates the benefit of care in an academic setting, and Houstonians are fortunate to have access to so many research studies through collaboration with academic institutions across the city. By seeking care from a UTHealth physician at UT Physicians or Memorial Hermann, patients have access to all the latest treatments available for even new and emerging diseases. We are staying on top of the research and contributing to the research to help as many patients as we can in the fight against COVID-19,” said Bindu Akkanti, MD, associate professor of critical care medicine with McGovern Medical School, pulmonary medicine specialist at UT Physicians, and attending physician with Memorial Hermann-TMC.

While she wishes it could have been under better circumstances, Hajjar says she is grateful to have had the chance to participate in COVID-19 research that could have saved her life.

“Dr. Akkanti is amazing. She’s so sweet and you can tell she cares about her patients and has such a love for science. She kept up with me and my family through text even after our discharge to make sure we were doing OK. You can tell she’s just excited to help her patients,” Hajjar said.

Now Hajjar is considering donating convalescent plasma herself to pay it forward. Anyone interested in donating blood or plasma can visit giveblood.org.