The Cleveland Clinic has begun enrollment for a nationwide trial to test an anti-malarial drug’s effect on treating the coronavirus.
The phase 3 clinical trial will examine the impact of small doses of hydroxochloroquine against a control group given a placebo. Hospitals across the country will participate, including the Cleveland Clinic.
Preliminary lab data shows hydroxochloroquine could have an effect on COVID-19, according to the Cleveland Clinic’s Dr. Abhijit Duggal. The trial will test it in a clinical setting on hospitalized patients with COVID-19 infections.
“We’ve not really done any kind of studies related to hydroxochloroquine and COVID-19 or other coronavirus infections before,” Duggal said.
President Donald Trump has touted the drug's promise in treating COVID-19, but researchers say more study is needed.
Patients receiving the treatment will get two 400-milligram doses of the drug on the first day, reduced to two 200-milligram doses per day over the next four days. The study will compare death rates, mechanicalized ventilation rates and duration of hospital stays to determine the drug’s effect.
“We really don’t know what its effect would be in patients who are coming in with COVID-19 infections, and whether we would really see anything different in that population that’s not been described in other patients,” Duggal said.
Against malaria, hydroxochloroquine alters the immune system and changes the disease’s process, Duggal said. It could result in less severe illness, he said.
“Any drug that we use, we have to make sure we study it the right way, so that we understand if there is potential benefit,” Duggal said, “but also to look and see if there are any harms associated with the drug.”
Most patients typically tolerate the drug, Duggal said, but it does pose risk of cardiac arrhythmia in some cases.
“If there’s any indication that any patient might be predisposed to developing heart arrhythmia due to exposure to the drug, those patients will be excluded [from the trial],” Duggal said.
The study will include a total of 510 patients from multiple sites across the country, Duggal said. The timeline for determining the drug’s effects depends on how long it takes to enroll, he said.
“Because of the implementation of social distancing and other factors, we are seeing states slow down in the rates of infections,” he said. “It’s really going to depend on how quickly we can get these patients in.”
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