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/
Picha ya jalada na Eddie Gasper na Edgar Walters katika Texas Tribune, Oktoba 1, 2020 Katika mbio ya kuendeleza chanjo na matibabu mengine ya kukomesha kwa wagonjwa wa coronavirus, wakati huo huo, Texas imeibuka kama tovuti inayoongoza kwa utafiti wa COVID-19. Jimbo hilo lina vyuo vikuu vingi vya utafiti, mamia ya hospitali na kiwango cha juu cha maambukizi ya virusi vya corona, na ni eneo la majaribio ya kliniki 130 ya kuchunguza chanjo na matibabu ya virusi vya corona. Hiyo ni ya juu zaidi ya jimbo lolote isipokuwa California na New York, kulingana na Taasisi za Kitaifa za Afya. Wakati watafiti wanashindana kukusanya data juu ya wagombea wengi wa chanjo - baadhi yao wamekuwa wakichukua washiriki katika miji mikubwa ya Texas tangu Julai - wengine wanatafuta matibabu kusaidia kuziba pengo kabla ya chanjo inapatikana kwa wingi, ambayo wataalam wanasema ni uwezekano wa mwaka mmoja mbali. Majaribio mawili mapya katika eneo la Houston yanaajiri washiriki kujifunza ikiwa kuwapa watu damu kutoka kwa wagonjwa waliopona COVID-19 kunaweza kusaidia kutibu maambukizi ya hatua ya mapema au hata kuzuia watu kuambukizwa ugonjwa. Utafiti huo unazingatia ufanisi wa plasma katika kupambana na virusi, ambayo ni sehemu ya rangi ya manjano ya damu inayobaki baada ya chembe nyekundu na nyeupe za damu, platelets, na sehemu nyingine za seli kuondolewa. Plasma ina protini, ambayo ni protini za kupambana na vimelea ambavyo mwili huunda katika majibu yake ya kinga kwa maambukizo. Watafiti wanataka kuona ikiwa plasma yenye antibodi nyingi kwa COVID-19 inaweza kusaidia mtu ambaye amepatikana na virusi vya corona hivi karibuni kuzuia maambukizi. "Utafiti huo ulionyesha kuwa mtu aliye karibu na mtu mwenye maambukizi ya ""mwenyewe"" kwa zaidi ya dakika 15 bila kutumia kinyago cha uso." Watafiti wanasema kwamba ikiwa matibabu ya plasma yatakuwa na ufanisi, yanaweza kusaidia kuzuia milipuko ya ugonjwa huo kuenea katika nyumba za uuguzi, magereza au maeneo mengine ambapo hatua za kutenganisha kijamii ni ngumu kutekeleza. Utafiti huo unafanyika kama jaribio la kliniki la kipofu mara mbili, ambapo wala mgonjwa wala daktari hawajui ikiwa mgonjwa anapokea matibabu au plasma ya kudhibiti ambayo haina antibodies kwa COVID-19. "Kwa kuwa hatuna chanjo, basi unaweza kufanya kitu kinachoitwa chanjo ya kutokuwa na athari ambapo unachukua kingamwili ambacho mtu mwingine amefanya, ""alisema Dk Shmuel Shaham, profesa msaidizi wa dawa katika mgawanyiko wa magonjwa ya kuambukiza katika Chuo Kikuu cha Johns Hopkins School of Medicine na kiongozi wa masomo." Jaribio la pili la aina hiyo litazingatia watu ambao wamethibitishwa kuwa na maambukizi ya coronavirus. "Swali la utafiti ni kama kupokea infusion ya plasma iliyojaa antibodi inaweza kuzuia mgonjwa kutoka kuwa mgonjwa sana au kutoka hospitalini. """ "Unaweza kuangalia hali ambapo unaweza kufikiria mtu kwenye meli inayobeba ndege ambayo imeambukizwa, na kisha unaweza kusaidia baharia huyo nje na plasma, lakini kisha unaweza pia kusaidia watu wengine kwenye meli ambao wamefunuliwa pia, ""Shoham alisema." "Wanafunzi walichagua Houston kama tovuti ya utafiti ""kwa sababu ni aina ya mchoro wa Venn"" na ""vikundi muhimu kwa ajili ya kazi kama hiyo ya kuingiliana, ""Shoham alisema: kituo cha matibabu imara, idadi kubwa ya watu, na ""watu wengi na coronavirus."" Wizara ya Ulinzi ya Marekani ni kufadhili majaribio mawili ya kliniki ya plasma, watafiti alisema, na timu ya Houston matumaini ya kuajiri washiriki 50." Taasisi ya Kitaifa ya Afya pia ilitoa dola milioni 8 kwa ajili ya utafiti wa ziada wa plasma, msemaji wa chuo kikuu hicho alisema. Utafiti huo ulianza New York, lakini wakati jimbo hilo lilipopunguza kiwango cha maambukizi ya COVID-19, watafiti walitafuta washirika katika maeneo mapya, ikiwa ni pamoja na Texas. "Kwa bahati mbaya bado kuna watu wengi huko Houston ambao wanakuwa na ugonjwa wa corona, na tunashuku kwamba wakati shule zinarudi kwa kawaida na tunapoanza kupunguza vizuizi vyetu, tunaweza kuona mgongano tena, ""alisema Daktari Bela Patel, mmoja wa wachunguzi wakuu wa utafiti na makamu wa mkuu wa ubora wa huduma za afya na mkurugenzi wa mgawanyiko wa dawa za huduma muhimu katika Shule ya Matibabu ya McGovern na UT Hermann Memorial-Texas Medical Center." Wafanyakazi wa huduma za afya ambao waliambukizwa virusi wanaweza kuwa wagombea wazuri wa jaribio la kliniki, Patel alisema, lakini sio wao tu wanaostahili. "Mfano wa kawaida ni mjukuu ambaye anakuja nyumbani kuwatembelea babu na nyanya na anageuka kuwa chanya... na alitumia jioni kula chakula cha jioni cha saa tatu na babu na nyanya", alisema. "Katika mahojiano ya hivi karibuni na jarida la American Medical Association, Dk Anthony Fauci, mkurugenzi wa Taasisi ya Kitaifa ya Madhara na Magonjwa ya Kuambukiza, alisema kuna ushahidi mwingi unaoonyesha matibabu ya plasma ni salama, lakini ""hatujui kwa uhakika ikiwa yatakuwa na ufanisi.""" "Uhakika juu ya plasma ya kupona kama matibabu ya visa vikali vya COVID-19 ni ya kuahidi lakini haijakamilika, ""Daktari Francis S. Collins, mkurugenzi wa Taasisi za Kitaifa za Afya, alisema katika taarifa ya habari." """Wakati ulimwengu unangojea chanjo yenye ufanisi, ni muhimu kwamba kwa wakati mmoja tuongeze chaguzi za matibabu kwa wale ambao kwa sasa wanateseka kutokana na athari mbaya zaidi za ugonjwa huu,"" alisema Dk. Maafisa wa afya nchini Marekani wametangaza wiki iliyopita kuwa wameidhinisha jaribio jingine la chanjo ya COVID-19 ambalo linaripotiwa kuwa na mipango ya kuajiri washiriki huko Texas. Johnson & Johnson ni kampuni ya nne kuanza majaribio makubwa ya kliniki, nyuma ya Moderna, Pfizer, BioNTech na AstraZeneca, ambayo yote yana majaribio yanayoendelea huko Texas. """Hakuna uwezekano wa kupata chanjo inayopatikana kwa wingi kabla ya vuli ijayo,"" alisema Dk Peter Hotez, mtaalam wa chanjo na mkuu wa Chuo Kikuu cha Kitaifa cha Tiba ya Tropiki katika Chuo Kikuu cha Tiba cha Baylor, katika tamasha la 2020 la Texas Tribune." Lakini kufikia mwisho wa mwaka, dozi fulani za chanjo zinaweza kupatikana kwa watu kutoka kwa idadi ya watu walio hatarini, alisema. Hotez alisema mawasiliano ya makampuni ya dawa na maafisa wa afya wa Marekani kuhusu matatizo yoyote yanayotokea wakati wa majaribio ya chanjo ni muhimu kwa kufanikiwa, hasa wakati watu wanazidi kutokuwa na imani kwa chanjo inayowezekana. Uchunguzi wa hivi karibuni wa Axios-Ipsos uligundua kuwa Wamarekani 6 kati ya 10 wanasema hawatatumia chanjo ya COVID-19 mara tu itakapopatikana. Uchunguzi wa uchaguzi huo ulionyesha mchanganyiko wa wanasayansi wakihimiza subira na ping-pong ya kisiasa ya kusisitiza kwa Rais Donald Trump kwamba chanjo itapatikana kabla ya Novemba na kukataa kwa wanademokrasia ahadi hiyo. "Tutahitaji kiwango kisichokumbukwa cha mawasiliano, ambacho hatuna sasa hivi, kwa bahati mbaya", Hotez alisema. Alisema ana "kiwango cha juu cha uaminifu" katika sayansi ya chanjo lakini ana wasiwasi dhana zisizo za kawaida zinaweza kuharibu mchakato huo. Fauci, katika mahojiano ya baadaye katika Tamasha la Texas Tribune, alirudia wasiwasi huo. Ni "kushtua" kwamba watu wengi wanashindwa kupata chanjo, alisema, akilaumu "mawasiliano mchanganyiko ambayo yametoka Washington" kwa kupungua kwa uaminifu wa umma. Wakati huo huo, viongozi wa majaribio ya kliniki ya chanjo wanasema wameona idadi isiyo na kifani ya watu wakiomba kujiandikisha. "Ni jambo la kawaida kwa karibu washiriki wote wa utafiti ni kwamba wanafanya hivyo kwa madhumuni ya kujaribu kuwa na msaada, kusaidia watu katika siku zijazo hata kama wanafikiri hii inaweza kuwa na msaada kwa wenyewe, ""alisema Dk Gretchen Crook, mtafiti mkuu wa utafiti wa kliniki katika Kliniki ya Mkoa wa Austin huko Wilson Park, ambayo inaendesha jaribio la kliniki la kipofu mara mbili na mgombea wa chanjo ya Pfizer-BioNTech." Kufikia katikati ya Septemba, kliniki hiyo ilikuwa imeweka karibu washiriki 150 katika jaribio lake la kliniki na ilikusudia kujiandikisha karibu 100 zaidi. "Karibu kila mtu anayekuja ana maoni haya kwamba hii ni fursa ya kipekee sana ya kufanya tofauti ulimwenguni, kitu ambacho wamehisi kutokuwa na msaada kwa miezi kadhaa iliyopita wakitazama msiba huu ukiendelea,"" alisema." "Kama ilivyoelezwa katika makala ya awali ya ""Textbook"" ya 2020 ya ""Textbook"" ya 2020 ya ""Textbook"" ya ""Textbook"" ya 2020 ya ""Textbook"" ya ""Textbook"" ya ""Textbook"" ya ""Textbook"" ya ""Textbook"" ya ""Textbook"" ya ""Textbook"" ya ""Textbook"" ya ""Textbook"""