The Roche Cobas 6800 Analyzer based at Tulane Medical Center produces results for COVID-19 tests in just four hours. The testing project is a joint effort between TUMC, LSU, and LSUHSC/UMC. The degree of ultraviolet light determines which samples are positive. (Tulane University Medical Center)

In this time of crisis, it’s been all-hands-on-deck to collectively fight against a very formidable adversary, COVID-19.  Institutions and individuals have quickly produced innovations in testing, expanded clinical trials for new treatments, invented alternatives to necessary medical equipment, and have taken on the race for a vaccine.

Availability of tests for the coronavirus has been a problem throughout the country. Though Louisiana is among the top states for coronavirus testing per-capita, Gov. John Bel Edwards has repeatedly complained that testing levels are not where he wants them. Meanwhile, delays in getting timely results have been equally problematic. 

“In the end of March, I had chills and body aches, and didn’t know whether I had the flu or COVID-19,” remembered Melissa Stoltz.

“When my fever reached over the 101.4 threshold, I headed to the Alario Center for testing. I was told my results would be forthcoming in 3 to 5 days.  The actual results arrived 12 days later, after my symptoms were gone. It turns out I was positive. Fortunately, I had self-quarantined.”

Stoltz’s results came from LabCorp. Quest, the country’s other lab giant, had similar problems with delays. Neither company responded to requests for comments, but past statements to media outlets have indicated the labs were overwhelmed with an unexpected volume of tests needing analysis.

Meanwhile, the large university-based hospitals in New Orleans teamed up to produce a test that gives results in four hours.  A laboratory based at Tulane Medical Center used its Cobas 6800 analyzer, which can run 200 tests a day. LCMC Health, which runs five hospitals in the New Orleans area, was able to obtain the chemicals necessary for that test from Roche Diagnostics, a pharmaceutical company based in Switzerland.  (The Roche test was only available at University Medical Center and Tulane Medical Center, but LCMC this week announced that it is deploying rapid-testing to patients throughout its system beginning Tuesday.)

In order to initiate this rapid-result testing, the FDA issued Emergency Use Authorization to test patients who showed signs and symptoms of the COVID-19 infection.   This particular test uses ultraviolet light to determine if a specimen is positive or negative. 

“It’s been important for us to know as soon as possible whether a patient has COVID-19 or not,” explained Dr. Byron Crawford, medical director of the Tulane Medical Center Laboratory.  “You want to get those who test negative out of the hospital quickly, so as not to tie up valuable healthcare workers, and PPE.  This way, those testing positive can be isolated immediately.”

The machinery was previously used to measure the presence of other viruses such as HIV-1, Cytomegalovirus, and Hepatitis C and B viruses.

In the last three weeks, nearly 2000 tests for COVID-19 have been run on the Cobas 6800 Analyzer.  With added platforms and additional companies coming out now with new testing systems, the turnaround time has shortened in the last couple of weeks for the patients of Louisiana.

Limited supply of ventilator drugs prompts development of new technique

There’s been much written about the shortage of ventilators as the incoming cases peaked in New Orleans the last two weeks.  What is a lesser known concern is the shortage of drugs which are necessary to intubate (the process of inserting a tube into the trachea) and keep comfortable those patients needing ventilation.  

With 461 patients still on ventilators in the state, it’s not a problem which has escaped those running ICU’s.  In an April 1 letter to Vice President Mike Pence, who is leading the White House Coronavirus Task Force, the American Society of Health-Systems Pharmacists warned that drugs associated with ventilator use were in short supply, saying that ventilators “could be rendered useless without an adequate supply.”  Some of these drugs like propofol (traditionally used in operating rooms ) have had periodic shortages over the years, but the current pandemic has exacerbated the situation for all sedatives and paralytic drugs.

“The reason usage is way up is that an operating room situation, for instance, requires a very finite amount of anesthesia,” said Dr. Ben DeBoisblanc, professor of medicine and physiology at LSU Health Sciences Center.  “But COVID-19 patients requiring a ventilator need to be deeply sedated for many days to keep them on the ventilator and get their oxygen saturation up.  So we’re switching up paralytics, ventilating many patients without them, and using sedatives like ketamine, which can now be used in the ICU, because Fentanyl and Propofol are in very short supply.”

“It’s imperative that everyone is well versed in dosages in a variety of different medications,” explained Dr. Abdul Khan., a pulmonary intensivist and director of Ochsner’s West Bank ICU.  “So when we started running low on Fentanyl, we reached for Dilaudid.  When the Propofol is in short supply, we switch to Versed or Ativan or morphine. I’m not a businessman, but it’s perplexing to me why manufacturers cannot keep these supplies up.”

Less than one-third of patients who go on ventilators with COVID-19 survive, according to the U.S. Agency for International Development’s infectious disease unit.  That’s because the process of ventilating a patient isn’t therapeutic, meaning they don’t fix the ailments that put patients on them. They are instead an opportunity to buy time while patients try to recover.  But they have their share of side effects, ranging from acute respiratory distress syndrome (ARDS) to infections brought on by artificial breathing tubes.  This is why ventilation without intubation can be preferable, but until LSU recently developed an alternative ventilator which doesn’t require intubation, this wasn’t a possibility.

“The face mask ventilator, as it’s known, can now provide a safe alternative to traditional ventilators,” said Kyle Happel, M.D., LSU Health Sciences Center pulmonologist.  “This type of ventilator had previously been deemed unsafe for healthcare workers as escaping air from the facial mask could contaminate ICU staff with the virus.  However, we’ve devised a viral filter which now keeps the hospital staff safe.”

The American Lung Association has noted that patients are tolerating the device well, and they are seeing fewer lung infections amongst patients on this type of ventilator.  This would also alleviate any future needs to put more than one patient on a single ventilator, a situation which has already occurred in New York City, but which many physicians have decried as a desperation measure.

“Putting two people on a ventilator is a horrible option,” explained Dr. Joe Kanter, assistant state health officer at the Louisiana Department of Health in Baton Rouge.  “Technically you can hook more than one patient to the ventilator but you lose the ability to dial in specific settings for each individual.  Unlike comatose patients, COVID-19 patients require minute-by-minute adjustments. An analogy would be that when you’re driving you can put your car on cruise control, and on a straight highway it works.  Now, imagine an 18-wheeler driving through the hairpin turns of the Alps. … Constant adjustments would be needed.”

Testing underway for possible treatments

While we’ve made adjustments for lack of equipment and testing, there is still no FDA-approved treatment for COVID-19, although there’s been much talk about hydroxychloroquine in combination with the anti-viral drug Remdesevir.  

Chloroquine is an anti-malarial drug which is also used to treat patients with lupus and rheumatoid arthritis.  Remdesivir was previously tested in Ebola patients and an article in the April 10 issue of the New England Journal of Medicine suggests clinical improvement in 36 of 53 COVID-19 patients, but it’s a small study and not a randomized clinical trial with a control group.  Meanwhile, LSU Health New Orleans School of Medicine has enrolled its first patient in a randomized clinical trial to evaluate the safety and effectiveness of hydroxychloroquine alone, and in combination with azithromycin, an antibiotic used currently for the treatment of bacterial infections.  But, this is a treatment trial only. Doctors stress using chloroquine as a preventive measure has no basis, and the drug has side effects, including dangerous heart arrhythmias.

“There is some limited evidence that these medications hold promise in shortening the disease course and decreasing the viral load – the amount of virus in respiratory samples,” adds Dr. Meredith Clement, MD, Assistant Professor in the Section of Infectious Diseases at LSU Health New Orleans School of Medicine and the trial’s Principal Investigator. “But we haven’t really had any reliable data to date.”

Six hundred hospitalized patients from UMC will be enrolled in the various combination studies with close monitoring of recovery times, and side effects.  Patients have the option to withdraw from the study at any point.

Meanwhile, we await an upcoming finger-prick home test which would quickly alert one to exposure to the virus, by showing blood antibodies providing immunity to COVID-19.  On April 2, the FDA issued its first Emergency Use Authorization for a rapid antibody blood test developed by Cellex for use in laboratories. 

And, clinical trials have begun everywhere to find a vaccine for this highly contagious and lethal virus, one notably in Covington, Louisiana at The Tulane National Primate Research Center where the most promising national vaccines and treatments will be evaluated on nonhuman primates.

With nearly 900 deaths in the state since the pandemic began, the mother of invention has certainly been necessity, and our medical experts have stepped up to meet the challenge and find solutions.