Doctors are running a clinical trial to see if a popular anti-depressant might keep someone from becoming severely ill with COVID-19.
The researchers at Washington University of St. Louis are recruiting 1,100 people in the beginning stages of COVID-19 to test out the drug fluvoxamine, also known as Luvox.
While an anti-depressant may seem like an unlikely candidate to fight COVID-19, a small study in November indicated it might have some success, and it’s been known for years that modern anti-depressants, called selective serotonin reuptake inhibitors, have anti-inflammatory properties. Inflammation plays a key role in COVID-19, resulting in complications such as blood clots and swollen “COVID toes.”
In order to get results in weeks instead of months — an important time difference while thousands are dying of COVID-19 every day – researchers are conducting the study in an unorthodox way. They’re mailing the medicine to patients’ homes around the country, and patients will monitor their health and report back to study staff, instead of having patients go to the researchers.
Lenze said it has gone well so far — with one little hiccup that was easily overcome.
“I have a funny story about a participant in New Hampshire. We shipped him the study medication, and he called saying it got left in a snow drift a quarter mile from his house,” said Dr. Eric Lenze, the study’s principal investigator. “He asked if it was still OK to take it, and we said yes, it’s fine. I’m a veteran of clinical trials, and that was a new one for me.”
Smaller study showed promise for fluvoxamine
The study started in December and has recruited a few dozen participants so far. The researchers say they could have results by February.
In the study published in November in the Journal of the American Medical Association, among 80 patients took fluvoxamine, none developed low oxygen levels. Of 72 patients who took a placebo — a pill that does nothing – six developed low oxygen levels.
One of the patients who took fluvoxamine was hospitalized with dehydration. Four of the patients who took a placebo were hospitalized with COVID-19 related symptoms, and one ended up in the intensive care unit on a ventilator. The researchers did not look to see whether the hospitalization differences between the two groups was statistically significant.
“Because of study limitations, these findings need to be interpretated as hypothesis generating rather than as a demonstration of efficacy,” the authors wrote in the November study.
Lenze and his colleagues are currently doing the larger study because the earlier study was too small to make definitive conclusions.
An unorthodox study
The Washington University researchers are looking for participants who have tested positive for COVID-19 and have had symptoms for a week or less.
Several aspects of the study are unorthodox.
The researchers won’t physically check the patients. Instead, along with the study drugs, the researchers send the participants a thermometer, blood pressure cuff, and pulse oximeter, a device placed on the fingertip to measure blood oxygen levels. Patients record their measurements on the study’s website, and research staff call patients daily during the early part of the trial.
This new way of doing clinical trials has already proven to be efficient.
The Washington University researchers modeled their study on one done this spring by Dr. David Boulware at the University of Minnesota, who shipped hydroxychloroquine and placebo pills to participants all over the US. Within a matter of weeks, the study revealed that hydroxychloroquine, a drug hyped by President Trump, didn’t work against COVID-19.
“The story of how quickly they got that done is extraordinary,” Lenze said. “We borrowed their techniques for our trial and they’re working well.”