Coronavirus: ‘Innovative’ clinical trials to treat COVID-19 underway at Baystate Health

SPRINGFIELD — Dr. Andrew Artenstein, head of Baystate Health’s coronavirus command center, said its COVID-19 patients are enrolled in “at least one” clinical trial for the respiratory disease for which there is no approved medical treatment.

“We have embarked on several clinical trials for experimental therapies for COVID-19 and have enrolled several patients into at least one, a trial of an inhibitor of interleukin-6, a substance produced by the body in response to COVID-19 infection that may play a role in the severe inflammation that affects some infected patients,” said Artenstein, Baystate’s chief physician executive and chief academic officer. “We are close to launching several other clinical trials.”

The infectious disease specialist, who was interviewed on CNN recently about the challenges of treating the pandemic caused by a novel coronavirus first identified in China in early January, added, “It is important to remember, especially with all that is being said in various quarters regarding potential specific therapies for COVID-19 that none of these therapies has yet been scientifically proven to be effective.”

“That is the whole purpose behind a clinical trial—to rigorously study the therapy to determine if it actually has a beneficial effect and if that beneficial effect outweighs any potential adverse effects,” Artenstein said.

Artenstein, who has studied retroviruses like SARS-CoV-2, which causes COVID-19, said Baystate, like other hospitals across the country, is employing a number of “innovative approaches” to treat the severely ill with the disease, including a technique called prone positioning in which the patient is placed on their side or stomach to improve oxygenation and reduce the need for invasive ventilation.

“In managing critically ill patients suffering from COVID-19 infection,” Artenstein said Baystate Medical Center’s intensive care group of “highly skilled, multi-disciplinary, collaborative teams” has been “employing several innovative approaches to the care of these patients, such as high-flow oxygen therapy and positional maneuvers such as the prone position, to improve the ability of our patients to get adequate oxygen into their bodies.”

“These interventions have helped reduce the need for some of these patients to require mechanical ventilation,” Artenstein said.

Baystate Health announced March 14 that it treated its first confirmed case of COVID-19. It now has close to 200 people hospitalized with COVID-19 with the majority of these cases not in ICU.

Artenstein said, “Probably the most common reason why a patient suffering from severe COVID-19 illness requires ICU-level of care is the need to go on a ventilator in order to ensure the adequacy of oxygenation.”

“Our (intensive care) teams can provide a lot of benefits to patients up to a certain point in severe illness using an entire, expanded repertoire of advanced, physiologic techniques to help oxygenate the lungs, but the disease progresses in some patients to the point where they need the ventilator,” Artenstein said.

He said that these “patients must be in an ICU” and, of the average length of stay, said “for patients in the ICU, most of them on ventilators, is about 9 days.”

He added what Baystate is seeing in the severely ill in terms of existing chronic conditions is similar to what is being reported in “medical literature from the U.S. and abroad."

“Most - but not all - of patients with severe, complicated COVID-19 infections appear to have underlying risk factors such as advanced age, underlying cardiovascular, lung, or kidney disease, cancer, morbid obesity, or diabetes mellitus,” Artenstein said.

Artenstein noted that studies to date indicate “that most people with COVID-19 infection are not severely ill and are able to safely manage through their illness at home with rest, fluids, and possibly symptomatic treatment like Tylenol to reduce fevers.”

“A minority of patients, however, will require hospital level of care,” said Artenstein of patients, not necessarily critically ill, but in need of supplemental oxygen, intravenous fluids and antibiotics to address secondary infections.

“Most people in this subgroup do not require ICU level of care but will still need several days of hospitalization to improve enough to be able to be managed at home.”

He added, “The main reason why a patient may need with a COVID-19 infection may need to be hospitalized is that they are short-of-breath related to inflammation in the lungs caused by the virus.”

“This inflammatory response makes it difficult for them to get adequate levels of oxygen into their lungs and blood. These patients need supplemental oxygen therapy.”

Artenstein these patients also “frequently need to get intravenous fluids to make up for the fact that they lose more fluids than they are able to take in and can get fluid depleted.”

“Also, some of these patients may develop a secondary pneumonia with bacteria and may need antimicrobials for this. Patients with advanced age and/or underlying chronic medical conditions tend to be at risk for more severe illness in general with COVID-19.”

Artenstein said, “The average length-of-stay for non-ICU patients with COVID-19 infection is about 5 days at Baystate Medical Center.”

“This is not significantly different than the average length of stay for our hospitalized population at baseline, although we must remember that this is a single diagnosis - and average length of stay at a hospital is usually reported for all patients with a mix of diagnoses,” he said.

“As far as we can ascertain, and this has not been scientifically studied, most of our discharged patients do not have any unusual or unexpected symptoms. Most patient recovering from COVID-19 infection will take some time to fully recover. This is always the case with hospitalized patients for any reason; this illness is unlikely to be any different.”

He said, “Many COVID-19 infected patients experience headaches as part of their overall symptoms.”

“However, beyond that, we have not seen any significant neurologic symptoms,” Artenstein said.

“There are scant case reports in the published medical literature on a few patients who have had more serious neurologic complications, but we have not seen that at Baystate Health at this point.”

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