Alberta’s hydroxychloroquine study cleared to resume, but remains on pause

Click to play video: 'Coronavirus outbreak: WHO set to resume hydroxychloroquine trial' Coronavirus outbreak: WHO set to resume hydroxychloroquine trial
WATCH ABOVE: World Health Organization (WHO) director-general Dr. Tedros Adhanom Ghebreyesus said on Wednesday that the WHO decided to resume its trial on hydroxychloroquine after the Data Safety and Monitoring Committee reviewed the trial data and recommended that there are no reasons to modify the trial protocol – Jun 3, 2020

An Alberta-wide trial investigating the effectiveness of hydroxychloroquine as a potential treatment for COVID-19 has been cleared to resume. However, it appears the province’s success in flattening the curve will keep the Alberta HOPE trial on pause for now.

The study was announced in mid-April and planned to recruit 1,600 Albertans to determine whether a prescribed five-day treatment of hydroxychloroquine can prevent hospitalization for those at highest risk of developing a severe illness.

Hydroxychloroquine is a drug that’s normally used to treat malaria.

“The goal of taking hydroxychloroquine or the placebo in this trial was to prevent worsening, to prevent people getting so bad they need to come to hospital with viral pneumonia,” explained Dr. Michael Hill, a University of Calgary professor and co-lead of the study.

READ MORE: Alberta testing anti-malaria drug as early COVID-19 treatment; U of A studying Ebola drug

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On May 26, the province announced the trial was temporarily suspended after a paper published in the Lancet showed people taking hydroxychloroquine were at higher risk of death and heart problems.

One day earlier, the World Health Organization announced it was temporarily dropping hydroxychloroquine from its global study into experimental COVID-19 treatment.

Click to play video: 'Coronavirus outbreak: WHO says uncertainty in hydroxycholoroquine resulted in pause of solidarity trial' Coronavirus outbreak: WHO says uncertainty in hydroxycholoroquine resulted in pause of solidarity trial
Coronavirus outbreak: WHO says uncertainty in hydroxycholoroquine resulted in pause of solidarity trial – May 25, 2020

The Alberta HOPE trial temporarily suspended enrolment so the data could be reviewed.

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On Thursday, Hill said the trial’s safety committee has given them the go-ahead to resume. However, it seems the province’s decrease in active cases has presented a new issue.

“We’re still suspended but not because we couldn’t start. Our safety committee has reviewed everything and said that, ‘Look, the trial looks totally safe. There’s no major adverse affects with hydroxychloroquine,'” Hill said.

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“But right now we’re doing really well in Alberta because we don’t have many cases,” he said.

On Wednesday, Alberta’s chief medical officer of health announced 19 new cases of COVID-19 in the province. In total, Alberta had 344 active cases of the disease on Wednesday.

“We don’t have people to enrol,” Hill said. “We’ll probably stay in a mode of suspended enrolment for a while until we see whether there’s a rebound.”

READ MORE: ICU doctor sends stark reminder about COVID-19 with tweet showing Alberta ventilators

Hill said work continues with researchers looking into the data they’ve already collected, cleaning the data and doing follow-up work. The trial had enrolled 148 people.

“We’ve had no major adverse affects of the drug based on our data safety committee’s review. So it partly reflects the population we’re studying,” Hill said.

Doctors and scientists have since called the article’s conclusions into question, asking to make public the peer review comments that preceded publication.

READ MORE: Medical journal questioning findings of hydroxychloroquine coronavirus study

On Wednesday, the WHO said experts who reviewed safety information decided that its study could also resume.

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A spokesperson with Alberta Health issued a statement Thursday on the province’s trial, which read in part:

“The Alberta HCQ trials have been reviewed internally and by the external clinical advisors and the research leads assure us that the trials are safe,” Tom McMillan said.

“We have been working closely with the clinical research team and have confidence in the decisions made to date.

“We understand that the trial continues to be on pause, not because of safety concerns, but because of limited enrolment.

“We understand the trial will remain on hold for the next 10 days while the researchers determine whether to suspend for the summer pending fall recurrence of cases or close the trial formally with a plan for data pooling with international collaborators.”


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