Spotlight on coronavirus vaccines overshadows furious effort to find new treatments – Press Telegram


May safety from COVID-19 be present in medication so simple as pseudoephedrine and arthritis medicine? Flaxseed and turmeric extract? Fish oil, ibuprofen, nasal spray, Vitamin D?

Hopes are excessive that therapeutics may be hiding in plain sight within the drugs cupboard, however proof stays sparse as analysis continues. One 12 months into the pandemic, the U.S. Meals and Drug Administration has accepted only one drug to deal with COVID-19, and its results are modest. Just a few others, which mimic the work of pure antibodies, have obtained emergency use authorization, however these aren’t slam-dunks both.

So behind the scenes, with deaths mounting and clocks ticking, researchers work “with an intense sense of purpose” to research myriad compounds which may tamp down illness.

Recovered COVID-19 affected person Jason Garcia of San Diego donates plasma in April. It was transfused the identical day right into a affected person with the illness at St. Joseph Hospital in Orange. (Courtesy of St. Joseph Hospital)

The remedy piece of the pandemic puzzle hasn’t captured the general public creativeness — or as a lot of the general public purse — as has the space-race for efficient vaccines. Whereas the quest for therapies has suffered for the lack of laser-focus and high-level organization that propelled shots so swiftly into arms, creating therapeutics that may tame COVID-19 is important to saving lives, researchers say. Tens of millions gained’t have entry to vaccines for a lot of months — or longer. Some can’t, or gained’t, get vaccinated. A tiny fraction of vaccinated people may not reply to the jabs.

And plenty of anticipate COVID-19 to be with humanity endlessly.

“We’re looking out for therapeutics to assist individuals who aren’t sick sufficient to go to the hospital, which is the overwhelming majority of people that get COVID,” mentioned Prasanna Jagannathan, infectious illness specialist at Stanford Medication and assistant professor of microbiology and immunology.

Most sufferers recuperate at dwelling with out a lot drama, however an alarming quantity  — assumed to be nicely on the highway to restoration — have been abruptly slammed with crushing waves of signs that the phenomenon received a reputation: “The second-week COVID crash.”

“We noticed what occurred with this current surge,” mentioned Judith S. Currier, chief of UCLA’s Division of Infectious Ailments within the Division of Medication. “When individuals are identified as outpatients, they’re advised to remain dwelling and wait to see in the event that they get sick. We’ve got some concept of which individuals are at larger threat of getting very sick, of who must be within the hospital — however it’s not good.”

The tough a part of discovering a drug that works early within the an infection cycle has been discovering sufficient folks with recent COVID-19 diagnoses — lengthy earlier than there’s a “crash” or want for hospitalization — to take part in well-designed research of medication which may forestall the virus’ development.

“Our research mantra is, ‘Rise above COVID,’ ” mentioned Currier, who’s additionally chair of the worldwide AIDS Medical Trials Group, which is leading some COVID trials for the National Institutes of Health. “The entire concept is to deliver folks collectively to contribute to discovering the solutions. We encourage folks to consider how they might help advance science — it’s one thing they’ll do. We have to be ready for the longer term. Members have discovered the method actually rewarding and we’re so grateful for his or her contributions.”

Those that have very lately been identified can discover a research to take part in at www.riseabovecovid.org/en. In Northern California, research are underway at UC San Francisco, Stanford College, VA Northern California Well being Care System, UC Davis and several other different websites. In Southern California, they’re underway at UCLA, USC, UC Irvine, St. Joseph’s Medical Analysis, Riverside Medical Clinic, Loma Linda College Well being and several other different websites.

Courtesy CoronavirusPreventionNetwork.org. Credit score: Laura Lengthy CoVPN

“It’s all arms on deck,” mentioned Sarah Doernberg, affiliate professor in UCSF’s Division of Infectious Ailments, medical director of Grownup Antimicrobial Stewardship at UCSF Medical Middle and web site investigator for the trial. “Many scientists have pivoted their focus from no matter they have been doing — which was in all probability not finding out coronaviruses — to concentrate on figuring out remedies and understanding the immune response. That piece has been actually inspirational to see.”

At the moment’s instruments

At the moment, there are few tools in the toolbox.

“Sadly, that’s one space the place we’ve not made that a lot progress,” mentioned Edward Jones-Lopez, an infectious illnesses skilled at Keck Medication of USC. “Usually, for different illnesses, remedies are developed first, then vaccines comply with later. It occurs that, for this, the reverse is true.”

The anti-viral remdesivir is the one drug formally accepted by the FDA to date to deal with COVID-19, however it’s aimed toward hospitalized sufferers. It will probably intervene with the virus’ copy and will cut back hospital stays by a couple of days, however it isn’t a treatment.

Eight extra tongue-twisting medication have obtained emergency use authorization from the FDA — which permits them for use earlier than their effectiveness has been confirmed in large-scale, randomized medical trials — however none seems to be a house run, both. They vary from the monoclonal antibodies casirivimab and imdevimab, lab-made proteins that mimic the immune system’s capability to combat off dangerous pathogens, to baricitinib, an oral pill used to deal with rheumatoid arthritis by blocking enzyme exercise resulting in irritation.

The World Health Organization “strongly recommends” that corticosteroids — corresponding to dexamethasone, hydrocortisone or prednisone — be given orally or intravenously to sufferers with extreme and demanding COVID-19. These can tamp down immune system over-reaction to the virus, which has been linked to many deaths.

“For monoclonal antibodies, we’ve got knowledge from a number of research that recommend they lower down the danger of progressing to extreme illness by about two-thirds on common, given early in the midst of COVID-9, to sufferers with signs however not but with extreme illness,” mentioned Saahir Khan, infectious illness specialist and principal investigator of USC’s Keck Medication trial web site.

“That’s extraordinarily encouraging. The caveats are that a few of the new variants of COVID-19 could cut back the exercise of antibodies towards them, and there are fairly important logistical challenges. They need to be given by IV and monitored in a hospital-type atmosphere.”

Revamped pods in a UCLA car parking zone the place outpatients, early in COVID-19, assist researchers take a look at therapeutics to tamp down illness. (Courtesy UCLA)

Getting COVID-19 optimistic sufferers who don’t really feel nice and simply wish to curl up of their heat beds out of the home and over to medical websites for intravenous infusions hasn’t been simple. UCLA has revamped storage pods into non-public infusion cubicles to ease the best way.

“None of those is a silver bullet,” Khan mentioned.

Beneath investigation

However the search for a silver bullet, or several, continues.

Greater than 600 drug improvement applications are in planning phases, and 420 trials have been reviewed by the FDA. Scientists are combing digital well being information to see which commonly-used medication — like those in your drugs chest — could possibly be linked to raised COVID-19 outcomes for sufferers.

The search started in April, when the Nationwide Institutes of Well being launched the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, a public-private partnership to hurry improvement of essentially the most promising remedies and vaccines. Since then, researchers have evaluated hundreds of therapeutic agents and are looking for brokers that may do the work through a capsule or inhaler, and never simply by intravenous infusion.

Amongst these within the pipeline is Synairgen’s SNG001, an inhalable beta interferon. This kind of drug helps cut back irritation and the physique’s immune response.

Jagannathan, from Stanford, is among the lead investigators on interferon, and he likes what he sees.

“We’re actually enthusiastic about this for a few causes,” he mentioned. “Interferon appears to play a extremely vital position within the physique’s early response to an infection. There’s proof that individuals with poor signaling go on to have extra extreme illness, and early proof means that giving this explicit interferon could possibly be useful.”

A small, early trial in Israel of a protein referred to as EXO-CD24 appears to have helped some with moderate-to-serious cases of COVID-19.

After which there’s the stuff in your drugs cupboard — and already in your arm.

Fish oil? Vitamin D?

Then-President Donald Trump walks out of Walter Reed Nationwide Navy Medical Middle after remedy for COVID-19 on Oct. 5. (AP Picture/Evan Vucci)

At Vanderbilt College, Cosmin A. Bejan and his colleagues dove into data from electronic health records to see which already-in-use medication may be repurposed as potential remedy candidates for COVID-19.

In findings that shocked even the researchers, individuals who had lately had a pneumonia vaccine had a considerably decreased threat of demise from the coronavirus, as did those that had diphtheria and tetanus vaccines, in addition to those that had earlier publicity to flaxseed extract, methylprednisolone acetate, pseudoephedrine, omega-3 fatty acids, turmeric extract, ibuprofen and fluticasone, the energetic ingredient in Flonase and different allergy nasal sprays.

“I believe the discovering that pneumococcal vaccines (in addition to different vaccines) save lives in folks with COVID-19 is vital,” Bejan mentioned by e-mail. Additional randomized medical trials are wanted, he mentioned.

“It could be additionally nice to see replication of our outcomes by different research carried out on bigger and extra heterogeneous research populations,” Bejan added.

Blood thinners studied

The ACTIV consortium is also investigating blood thinners — together with apixaban, aspirin and heparin — to see if they’ll stop life-threatening blood clots in COVID-19 sufferers, in addition to testing medicines already accepted to deal with different circumstances, together with risankizumab, used to deal with plaque psoriasis, and lenzilumab, used to deal with most cancers sufferers experiencing cytokine storm from their therapies.

Hopes have been excessive for different frequent compounds as nicely, although such hopes typically fizzle.

After a lot hype about zinc and Vitamin C, a study published in the Journal of the American Medical Association found that no individual symptom resolved quicker with both alone, or a mix of the 2. Hospitalization charges didn’t considerably differ, both.

Vitamin D has had a second as nicely. In a single research, Vitamin D deficiency was present in 97% of severely unwell sufferers who required ICU admission, however in solely 33% of asymptomatic circumstances, writes former U.S. Surgeon General Richard H. Carmona and co-authors. However a study published in JAMA threw some chilly water on that, discovering that a excessive dose of vitamin D3 didn’t considerably cut back hospital stays for sufferers with average to extreme illness.

Former President Donald Trump as soon as touted hydroxychloroquine as a miracle treatment, but it turned out to do more harm than good.

Brian Patnoe will get a hug from his daughter, Elise Patnoe, upon his launch from Mission Hospital Laguna Seashore after battling COVID-19 in April. (Picture by Jeff Gritchen, Orange County Register/SCNG)

‘A marathon … not a dash’

The previous 12 months has, certainly, been traumatic, however the possibilities of surviving COVID-19 have considerably improved for the reason that daybreak of the pandemic, wrote NIH Director Francis S. Collins in a recent blog post.

“This enchancment stems from a number of components, together with the FDA’s emergency use authorization of a lot of therapies discovered to be protected and efficient for COVID-19,” he wrote. “But the hunt to save lots of extra lives from COVID-19 isn’t even near being completed, and researchers proceed to work intensively to develop new and higher remedies. …

“Our work is clearly a marathon, not a dash.”



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