RCTS essential in finding evidence-based treatments for COVID-19

Randomized controlled trials are critical in finding an evidence-based treatment for patients with COVID-19, according to a presenter at The Liver Meeting Digital Experience.

COVID-19 treatment guidelines from the NIH recommended using remdesivir (Gilead Sciences) and dexamethasone for some patients with COVID-19.

In one RCT, patients received 6 mg dexamethasone either orally or intravenously for 10 days either. “In patients receiving oxygen, in particular those receiving invasive mechanical ventilation, there was a benefit with respect to 28-day mortality,” Mark Sulkowski, MD, professor of medicine, chief of the division of infectious diseases at Johns Hopkins Bayview Medical Center and director of the COVID-19 Clinical Research Center at Johns Hopkins University, said during his presentation. “In contrast, in those with no oxygen requirement there was no benefit to dexamethasone. They suggested it was better in people with more advanced disease.”

Remdesivir had the greatest benefit in patients who received oxygen, he said. However, it had little benefit in patients with severe disease receiving high flow oxygen or mechanical ventilation.

“The antiviral remdesivir may be better in patients with earlier infection,” Sulkowski said.

He said RCTs provide evidence against the use of hydroxychloroquine and lopinavir/ritonavir (Kaletra, Abbott) in hospitalized patients.

Sulkowski said there were little data to recommend for or against convalescence and that more RCTS are needed. However, he also said that so far plasma is as safe with rare serious adverse events.

“Drug-induced liver injury must be considered in COVID-19 patients,” he said.

While immunomodulators under evaluation - including IL-C, interferons and JAK inhibitors - they are not recommended unless in clinical trials, Sulkowski said.

He also reported that some antivirals under investigation for non-hospitalized patients include anti-spoke protein monoclonal antibodies, peginterferon lambda and nucleoside analogue. But, he reported that there are no specific antivirals or immunomodulatory therapy recommended for non-hospitalized patients.

“It is critically important that we develop treatments that can be used to prevent and treat people with earlier infection,” he said.