Cover image by Eddie Gasper
By EDGAR WALTERS at the Texas Tribune, October 1, 2020
In the race to develop a vaccine and other stopgap treatments for coronavirus patients in the meantime, Texas has emerged as a leading site for COVID-19 research.
Home to massive research universities, hundreds of hospitals, and a relatively high rate of coronavirus transmission, the state is the site of 130 clinical trials investigating possible vaccines and treatments for the coronavirus. That’s the highest of any state other than California and New York, according to the National Institutes of Health.
While researchers race to collect data on a host of promising vaccine candidates — some of which have been recruiting participants in Texas’ biggest cities since July — others are looking at treatments to help bridge the gap before a vaccine becomes widely available, which experts say is likely a year away.
Two new trials in the Houston area are recruiting participants to study whether giving people infusions of blood from recovered COVID-19 patients can help treat early-stage infections or even prevent people from catching the disease.
The studies center around the virus-fighting efficacy of plasma, which is the yellow part of blood that remains after red and white blood cells, platelets, and other cellular components are removed. Plasma contains antibodies, which are pathogen-fighting proteins the body forms in its immune response to infections.
Researchers want to see if plasma rich with antibodies to COVID-19 can help a person recently exposed to the coronavirus prevent an infection from taking hold. Exposure is defined as being within 6 feet of a person, without a mask, who has an active infection, for more than 15 minutes.
Researchers say that, if effective, plasma treatments could help prevent outbreaks from spreading within nursing homes, prisons or other settings where social distancing measures are hard to enforce. The study is taking place as a double-blind clinical trial, in which neither the patient nor the doctor knows whether the patient is receiving the treatment or a control — plasma that does not contain antibodies to COVID-19.
“Since we don’t have a vaccine, then you can do something called passive immunization where you’re taking the antibodies that somebody else has made,” said Dr. Shmuel Shoham, an associate professor of medicine in the division of infectious diseases at Johns Hopkins University School of Medicine and a leader on the studies.
A second, similar trial will look at people who have confirmed coronavirus infections. The research question there is whether receiving antibody-filled plasma infusions can keep a patient from becoming severely sick or being hospitalized.
“You can look at situations where you can imagine a person on an aircraft carrier that is infected, and then you can help that sailor out with plasma, but then you can also help the other people on the ship who’ve been exposed as well,” Shoham said.
Researchers chose Houston as a study site “because it’s sort of a Venn diagram” were crucial elements for such work overlap, Shoham said: a robust medical center, a large population, and “a lot of people with coronavirus.”
The U.S. Department of Defense is funding the two plasma clinical trials, researchers said, and the Houston team hopes to recruit 50 participants. The National Institutes of Health also kicked in $8 million in funding with a grant to UT Health for an additional plasma trial, a university spokesperson said. That study began in New York, but as the state brought its level of COVID-19 transmission lower, researchers looked for partners in new hot spots, including Texas.
“Unfortunately there’s still plenty of people [in Houston] who are becoming positive, and we suspect that as the schools are returning back to normal and as we start loosening our restrictions, we may see a bump again,” said Dr. Bela Patel, one of the study’s lead investigators and vice dean of health care quality and division director for critical care medicine at the McGovern Medical School at UTHealth and Memorial Hermann-Texas Medical Center.
Health care workers who were exposed to the virus may be good candidates for the clinical trial, Patel said, but they’re not the only ones eligible. “The more common example is the grandson who comes home to visit grandparents and turns out to be positive … and spent the evening having a three-hour dinner with the grandparents,” she said. “That is a high-level exposure.”
In a recent interview with the Journal of the American Medical Association, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said there is a lot of evidence suggesting plasma treatments are safe, but “we don’t know for sure whether [they are] going to be effective.”
There is some preliminary evidence from observational studies that plasma may have helped severely ill, hospitalized patients, according to the National Institutes of Health.
“The evidence on convalescent plasma as a treatment for severe cases of COVID-19 is promising but incomplete,” Dr. Francis S. Collins, director of the National Institutes of Health, said in a news release. “While the world waits for an effective vaccine, it is vital that we simultaneously expand the options for available treatments for those currently suffering from the worst effects of this disease.”
In the meantime, large pharmaceutical companies are racing to develop a vaccine. U.S. health officials announced last week that they had approved another large-scale COVID-19 vaccine trial, which reportedly has plans to recruit participants in Texas. Johnson & Johnson is the fourth company to begin large-scale clinical trials, behind Moderna, Pfizer/BioNTech and AstraZeneca, all of which have trials running in Texas.
A successful, widely available vaccine is unlikely to materialize before next fall, Dr. Peter Hotez, a vaccine expert and dean at the National School of Tropical Medicine at Baylor College of Medicine, said at the 2020 Texas Tribune Festival last week. But by year’s end, some vaccine doses may be available for people from high-risk populations, he said.
Hotez said that drug companies’ and U.S. health officials’ communication about any setbacks that arise during vaccine trials is vital to a successful rollout, particularly amid growing public distrust of a potential vaccine.
A recent Axios-Ipsos poll found that 6 in 10 Americans say they would not take a COVID-19 vaccine as soon as it is available. Poll analysts said the hesitancy reflected a combination of scientists urging patience and the “political ping-pong” of President Donald Trump’s insistence that a vaccine will be available before November and Democrats’ pushback against that promise.
“We’re going to need an unprecedented level of communication, which we don’t have right now, unfortunately,” Hotez said.
He said he has a “high level of confidence” in the science of the vaccine but worries public misconceptions could derail the process.
Fauci, in a subsequent interview at the Texas Tribune Festival, echoed those concerns. It’s “disturbing” that so many people are hesitant to get a vaccine, he said, blaming “mixed messages that have come out of Washington” for waning public trust.
At the same time, leaders of vaccine clinical trials say they’ve seen unprecedented numbers of people asking to sign up.
“It’s a commonality of really almost all research participants is that they’re doing it for purposes of trying to be helpful, helpful for people in the future even if they think this may not be helpful for themselves,” said Dr. Gretchen Crook, the principal investigator of clinical research at Austin Regional Clinic at Wilson Parke, which is running a double-blind clinical trial with the Pfizer/BioNTech vaccine candidate.
As of mid-September, the clinic had enrolled about 150 participants in its clinical trial and aimed to sign up about 100 more.
“Almost everybody that comes in has this view that this is a really unique opportunity to make a difference in the world, something that they have felt helpless for the last several months watching this catastrophe unfold,” she said.
See the original article: https://www.texastribune.org/2020/10/01/texas-coronavirus-research/