COVID-19 patients on the antiviral remdesivir recovered about 30 percent faster than those on a placebo, the results of a major clinical trial showed Wednesday, as a top US scientist hailed the drug’s “clear-cut” benefit.

The patients taking part in a clinical trial of the drug have all had severe respiratory symptoms and fever, but were able to leave the hospital after less than a week of treatment, STAT quoted the doctor leading the trial as saying.

“The best news is that most of our patients have already been discharged, which is great.

“Partial data from an ongoing clinical trial is by definition incomplete and should never be used to draw conclusions about the safety or efficacy of a potential treatment that is under investigation.

There is no approved therapy for the Covid-19, which can cause severe pneumonia and acute respiratory distress syndrome in some patients. But the National Institutes of Health is organizing trials of several drugs and other treatments, among them remdesivir.

The drug, made by Gilead Sciences, was tested against Ebola with little success, but multiple studies in animals showed the drug could both prevent and treat coronaviruses related to Covid-19, including SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome).

Back in February, the World Health Organization said remdesivir showed potential against Covid-19.

Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days.

However, the trial does not include what’s known as a control group, so it will be difficult to say whether the drug is truly helping patients recover better. With a control arm, some patients do not receive the drug being tested so that doctors can determine whether it’s the drug that is really affecting their condition.

Trials of the drug are ongoing at dozens of other clinical centers, as well. Gilead is sponsoring tests of the drug in 2,400 patients with severe Covid-19 symptoms in 152 trial sites around the world. It’s also testing the drug in 1,600 patients with moderate symptoms at 169 hospitals and clinics around the world.

Gilead said it expected results from the trial by the end of the month.

“We understand the urgent need for a COVID-19 treatment and the resulting interest in data on our investigational antiviral drug remdesivir,” the company said in a statement. But it said a few stories about patients are just that.

“The totality of the data need to be analyzed in order to draw any conclusions from the trial. Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of remdesivir as a treatment for Covid-19.

Three physicians from Johns Hopkins University, in Baltimore, MD, have joined efforts to write an article outlining key action points that the United States healthcare community should take in response to COVID-19.

Drs. Amesh A. Adalja, Eric Toner, and Thomas V. Inglesby wrote the paper, titled “Priorities for the U.S. Health Community Responding to COVID-19.”

The doctors are all from the Johns Hopkins Center for Health Security, as well as the university’s Department of Environmental Health and Engineering.

Appearing in the journal JAMA, the article draws from experiences with similar epidemics — such as the 2009 influenza pandemic, the SARS epidemic in 2003, and the avian influenza A epidemic in 2005 — to outline key measures that the U.S. government and healthcare sector should take to deal with the new coronavirus.

Hospitals, clinics, and other facilities

First, write the authors, healthcare institutions should update preparedness plans that had been developed for the previous epidemics.

“Broadly speaking, those plans addressed the protection of healthcare workers, how to deal with staffing shortages, surges in patient numbers, triage issues, and management of scarce resources,” write Dr. Adalja and colleagues.

Second, hospitals and clinics, which have “critical roles” in the response to COVID-19, must establish clear “protocols for triaging and isolating patients suspected of having infection in emergency departments and urgent care centers.”

Importantly, write the authors, “Similar procedures need to be established in outpatient clinics, dialysis centers, and other medical facilities — especially nursing homes, assisted living centers, and long-term care facilities with particularly vulnerable populations.”

This is to prevent COVID-19 from disrupting regular treatments in medical care units, which would “compound the direct morbidity and mortality of the disease.”

Healthcare workers and ICU units

Protecting healthcare workers is another key priority in the COVID-19 response. This will require the use of personal protective equipment, updated hospital administrative policies, and special training of hospital staff, the authors note.

A considerable number of patients are likely to be severely ill, so hospitals must pay specific attention to preparing their intensive care units (ICUs), Dr. Adalja and colleagues write, explaining: 

“This planning includes evaluation of ICU bed capacity, the ability to augment ICU-level bed space with alternative care sites such as step-down units and postanesthesia care units, mechanical ventilator stock and supply chains, and the logistics of isolating and cohorting patients.” 

“Many hospitals operate at or near capacity already, and even an above-average flu season can cause operational disruption,” the authors point out.

Finally, the team emphasizes that — even though too little is currently known about COVID-19, and healthcare professionals will have to adapt their clinical approaches as more information becomes available — sticking to existing guidelines for pneumonia, sepsis, and acute respiratory distress syndrome (ARDS) is the best course of action.

“This may include the use of investigational antiviral or monoclonal antibody therapy,” the authors note.

More diagnostic tests needed ‘rapidly’

Furthermore, they write, clinicians must “rapidly” extend their diagnostic testing.

“To better understand the burden of COVID-19, medical and public health experts need to expand testing to all patients who have unexplained ARDS or severe pneumonia and ultimately to patients who have mild symptoms consistent with COVID-19.”

The researchers explain that the Centers for Disease Control and Prevention (CDC) — which initially performed all diagnostic tests — and public health labs do not have the capacity to perform testing on the scale that is necessary right now.

“To reach a high level testing capacity will require the major clinical diagnostic companies to develop and manufacture testing kits at large scale. Diagnostic companies may simply be able to add SARS-CoV-2 to existing nucleic acid–based respiratory viral panels or create standalone tests. Ideally, such diagnostic tests would be rapid,” the article cautions.

Also, serological assays, blood tests for specific antibodies, are necessary to help determine an accurate case fatality rate and for monitoring purposes, the authors point out.

Public health and social distancing

“From the outset, SARS-CoV-2 posed a near-impossible challenge for containment,” the team writes.

This is because the virus transmits very effectively; the authors note that the virus was “surreptitiously spreading for at least 6 weeks” and that it has “an epidemic doubling time of about 1 week.”

“As more and more countries report cases, including those with no link to the disease epicenter, it is clear that there are many more unrecognized cases in the world and that community transmission is happening in many countries.”

– Dr. Amesh A. Adalja et al.

Public health measures such as providing rapid diagnoses and isolating people with the virus are the most important actions that can slow the spread of SARS-CoV-2.

Tracking the contacts of people with the virus and placing them in quarantine may also be effective at this early stage of the epidemic.

“However, beyond a certain threshold, it will no longer be feasible to track all contacts.” At this point, actions classified as “social distancing” may be necessary. These include “cancellation of large gatherings, telecommuting to work when feasible, and school closures.”

However, such measures would come at a cost that must be accounted for. For instance, school closures would mean that “Many children who depend on school meals will not receive them, and many single parents will be out of the workforce.”

Finally, in addition to communicating health measures that everyone should take to reduce the spread of the infection, “It will also be important to communicate […] that persons who test positive for this virus but who do not need hospital care should stay at home while they are ill and not go to hospitals.”

“Hospitals may have serious challenges in handling the number of people who do need acute care, so it will be important for those who are infected but otherwise well to not contribute to hospital demands.” Dr. Adalja and colleagues conclude:

“Preparation will take time, so healthcare and public health systems need to move quickly forward in their efforts to be ready to confront this disease around the country.”

For information on how to prevent the spread of coronavirus, this CDC page provides advice.

MRI scans shows showing the average measurable difference in white matter brain damage in people with low inflammatory blood test scores (below median) and those with high scores (above median). 

A UCLA-led study has found that levels of six proteins in the blood can be used to gauge a person’s risk for cerebral small vessel disease, or CSVD, a brain disease that affects an estimated 11 million older adults in the U.S. CSVD can lead to dementia and stroke, but currently it can only be diagnosed with an MRI scan of the brain.

“The hope is that this will spawn a novel diagnostic test that clinicians can start to use as a quantitative measure of brain health in people who are at risk of developing cerebral small vessel disease,” said Dr. Jason Hinman, a UCLA assistant professor of neurology and lead author of the paper, which is published in the journal PLoS One.

CSVD is characterized by changes to the brain’s white matter—the areas of the brain that have a high concentration of myelin, a fatty tissue that insulates and protects the long extensions of brain cells. In CSVD, small blood vessels that snake through the white matter become damaged over time and the myelin begins to break down. This slows the communication between cells in the brain and can lead to problems with cognition and difficulty walking. And if the blood vessels become completely blocked, it can cause stroke.

The disease is also associated with a heightened risk for multiple forms of dementia, including Alzheimer’s disease.

Typically, doctors diagnose CSVD with an MRI scan after a person has experienced dementia or suffered a stroke. About a quarter of all strokes in the U.S. are associated with CSVD. But many cases of the disease go undiagnosed because of mild symptoms, such as trouble with walking or memory, that can often be attributed to normal aging.

In the new study, Hinman and colleagues focused on six proteins related to the immune system’s inflammatory response and centered on a molecule called interleukin-18, or IL-18. They hypothesized that inflammatory proteins that damage the brain in CSVD may be detectable in the bloodstream.

The researchers measured the levels of the proteins in the blood of 167 people whose average age was 76.4, and who had either normal cognition or mild cognitive impairment. As part of their voluntary participation in the study, 110 participants also underwent an MRI brain scan and 49 received a more advanced scan called diffusion tensor imaging.

People whose MRI or diffusion tensor imaging tests showed signs of CSVD had significantly higher levels of the six blood proteins, the researchers discovered. If a person had higher-than-average levels of the six inflammatory proteins, they were twice as likely to have signs of CSVD on an MRI scan and 10% more likely to very early signs of white matter damage. Moreover, for every CSVD risk factor that a person had—such as high blood pressure, diabetes, or a previous stroke—the inflammatory protein levels in their blood were twice as high, on average.

To confirm the results, the team performed the blood test in a group with a much higher risk for CSVD: 131 people who visited a UCLA Health emergency department with signs of stroke. Once again, the blood test results were correlated with white matter changes in the brain that were detected by an MRI.

“I was pleasantly surprised that we were able to associate blood stream inflammation with CSVD in two fairly different populations,” Hinman said.

In MRI reports, the changes in the brain’s white matter caused by CSVD are usually only categorized in general terms—as mild, moderate or severe. The blood test is a step forward, Hinman said, because it provides a more quantitative scale for evaluating the disease. That means the blood test can be used to follow the progression of the disease or to identify people who are candidates for prevention efforts or treatments for CSVD.

“We’re hopeful that this will set the field on more quantitative efforts for CSVD so we can better guide therapies and new interventions,” Hinman said.

“I feel like I’m being poisoned.” I will never forget the night I told my parents that I thought my breast implants were the cause of a decade’s worth of unexplained medical phenomena.

What started as a sudden onset of panic attacks 7 years ago transformed into a laundry list of debilitating mental and physical ailments that I was forced to cope with daily.

The day before my explant surgery, I tallied 49 symptoms that I was actively experiencing. I had received misdiagnoses of mental health conditions, such as panic disorder, anxiety disorder, depression, PTSD, and most recently, bipolar disorder.

I struggled with bouts of extreme insomnia, where I wouldn’t sleep at all for 2 to 3 days on end.

Doctors had prescribed pretty much every combination of SSRIs, benzos, stimulants, and sleep medications on the market. The slew of debilitating side effects from these drugs landed me in the ER too many times to count.

Physically, I experienced an onset of sudden food intolerances and allergies that caused digestive issues, such as acid reflux, GERD, and gastritis.

I lived with symptoms of autoimmune diseases, such as joint pain, swollen lymph nodes, and liver and kidney dysfunction, all with no conclusive diagnosis.

My feet and hands turned purple and were ice cold to the touch. My hair fell out in clumps in the shower, and the strands that remained were dry and brittle. My blood tests showed abnormal liver and kidney function, and my kidney grew a mass twice the size of itself. I experienced other unexplained symptoms, such as skin rashes, migraines, brain fog, and numbness and tingling in extremities.

The surgery changed everything

My entire life suffered from the toxic blow of this unexplained condition. Before I got sick, I was a college senior at USC, on the Dean’s list, with an abundance of friends. I was in a healthy relationship and involved in every extracurricular activity I could fit into my overpacked schedule.

I was headed to Nashville upon graduation to pursue my dream job of working in the entertainment industry. I was free of mental and physical ailments. It was the last time I can remember being effortlessly happy. I continually asked myself, “What happened to my old life? Will I ever get it back?”

From the outside looking in, it’s hard to understand. From the inside looking out, it’s hard to explain.

It’s difficult to put into words the dichotomy my life had become because, on the outside, I looked fine, but inside, my body was waging war on itself. The truth is that this illness took everything from me that I once recognized, admired, and valued about myself. My life bore no resemblance to the version I left behind almost a decade ago.

I spent entire days stuck in bed, ruminating on to-do lists I didn’t have the energy or motivation to begin, let alone complete. I got so anxious at times that I wanted to crawl out of my skin. Each day I woke up with the hope that today would be the beginning of a new start. I put in what felt like 150% effort, while I watched others coast along.

I went to bed every night with the notion that I hadn’t achieved nearly enough. I chalked it up to another day inside a body that wouldn’t work and a mind that couldn’t stop ruminating on the pain.

I fight for my health every day in a way most people don’t understand. I’m not lazy; I am a warrior.

At the height of my illness, I was taking five prescription medications to manage the mental symptoms alone. I was taking meds to wake up, meds to concentrate, meds to relax, and meds to fall asleep.

My entire life was chemically induced, and none of my emotions felt like my own. I was also a regular in the emergency room, thanks to the physical symptoms that accompanied this illness.

Most recently, I was brought in for stroke symptoms and unexplained bleeding from my mouth. After hours of bloodwork and imaging, I was sent home with a generic, temporary Band-Aid in the form of steroids, Benadryl, and a prescription for Xanax, but no answers.

From rock bottom came the answers

I am learning to be thankful for my rock bottom, as it was the catalyst that brought me the answers I was seeking.

I went home that night, and at an all-time low, I put out a desperate Facebook post explaining my situation. I was met with a reply from a college friend, directing me to Breast Implant Illness and Healing by Nicole.

After hours of scrolling through tens of thousands of women’s stories that sounded all too familiar to me, I reached a verdict. I was sure that my breast implants were the culprit.

“Save yourself a surgery,” the plastic surgeon who fitted my implants told me when I enquired about having my 7-year-old Mentor-brand, textured, silicone breast implants removed.

“I have been in practice for over 30 years, and you are the first person who has ever wanted them taken out. You aren’t going to like the way you look without them, and you will want them put back in.”

“I strongly believe that the proper removal of my breast implants was key to my recovery.”

I still have regrets about that day. After weeks of self-conducted research, I regret not bringing him the facts I had uncovered about certain implants. Some silicone breast implants contain carcinogens, neurotoxins, and cleaning agents, among other things.

Now, I don’t claim to have an MD, but it’s hard to believe that the almost identical symptoms that myself and thousands of other women with breast implants experienced were merely a coincidence.

There is a growing body of research suggesting that breast implants can cause autoimmune disorders in some women. The Food and Drug Administration (FDA) released a worldwide recall of Allergan textured breast implants last month in a bid “to protect women from breast implant-associated anaplastic large cell lymphoma.”

If you have breast implants, don’t panic. First, focus on identification of your symptoms and then move to explant.

I strongly believe that the proper removal of my breast implants was key to my recovery. An international list of recommended explant surgeons can be found here.

The detoxification process can take up to 2 years, so even though I have removed the source of my suffering, the symptoms still come and go like a clingy house guest who doesn’t pick up on social cues.

Recovery and rediscovering myself

I am now 2 months post-op and am already seeing improvements. Before my surgery, I had bloodwork done, and my liver enzymes were indicative of someone with lifelong alcohol dependency. Recently, my bloodwork has miraculously normalized.

The symptoms seem to be falling away one by one. The physical symptoms I mentioned, such as skin rashes, stroke symptoms, flu symptoms, and liver and kidney issues, have all gone. I have lost 30 pounds already, all of which was inflammation weight. I have even started weening myself off of antidepressants, as I feel so much stronger mentally.

For the first time in a decade, when I look in the mirror, I recognize the person staring back at me. We all have the same hours in a day, and this illness has taught me how to live them with purpose, to treasure every alert moment, and relish every second of pain free bliss. My perspective is shifting from hopeless to limitless.

The best part about recovery is when we get to rediscover ourselves, to find our passion, and to find our purpose.

I am still learning how to be thankful for my struggle because, without it, I wouldn’t have stumbled across my strength. I am learning that I’m not a victim for sharing my story, but a survivor setting the world on fire with my truth.

I am no longer ashamed of my journey, as I have emerged with an appreciation, a sensitivity, and an understanding of life that fills me with compassion, gentleness, and a deep loving concern for others.

In a society that profits from your self-doubt, liking yourself is a rebellious act.

I have learned the hard way never to let external factors dictate my sense of self-worth. If you needed to hear this today, you are beautiful just the way you are.

Your sheer existence is a miracle, and the sooner you accept that and start creating your life accordingly, the better.