How did TOGETHER recruit to a trial of hydroxychloroquine amidst widespread use?

How did TOGETHER recruit to a trial of hydroxychloroquine amidst widespread use?

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.

On May 20, 2020, Brazil’s Health Ministry recommended the widespread use of hydroxychloroquine and chloroquine for the early treatment of COVID-19. Less than two weeks later, on June 2, recruitment to TOGETHER began at several sites in Brazil. As described in ClinicalTrials.gov, the trial would study the effectiveness of hydroxychloroquine and Lopinavir / Ritonavir in patients with mild COVID-19. The patients would be randomized to each of the drugs alone or in combination. Notably, the randomization would also include placebo. The trial thus explicitly challenged the national guidelines.

Investigators described their recruitment process as follows:

“We used a network of local primary care centers in Brazil and sought the political support of local leaders to endorse the trial and encourage the population to participate.”

Our reporting suggests that they may also have used deception in the recruitment of volunteers to the study. There are three observations that suggest that that may be the case.

The publication describing the...

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