Matthew Pullen, MD: “After examining the data of our 821 participants, we did not find a significant difference in the risk of infection following exposure in those taking hydroxychloroquine and those taking placebo."
The debate about hydroxychloroquine’s effectiveness against COVID-19 continues, but for how long? A study unveiled yesterday added to the preponderance of evidence showing hydroxychloroquine isn’t effective. “We launched this trial not knowing what the answer was for the question: Does hydroxychloroquine prevent COVID-19 disease after exposure?” That’s what David Boulware, MD, MPH, told Infection Control Today®’s sister publication Contagion® yesterday.
Boulware’s study in the New England Journal of Medicine found that hydroxychloroquine is not likely to be an effective prophylaxis against COVID-19. “We designed a double-blind placebo-controlled trial to find out what the answer was,” Boulware continued. “While we are disappointed that this did not work, we are pleased that we found the answer.”
Why does this matter? Because Boulware’s findings came to light just a day after The Lancet and the New England Journal of Medicine cautioned assessment of hydroxychloroquine based on potentially faulty data from Surgisphere.
Boulware’s trial consisted of non-hospitalized adults who indicated a high-risk or moderate-risk exposure to COVID-19 through the household or an occupational setting. They were provided the study drug or placebo by mail within 4 days of exposure. This leaves the prophylactic treatment to take place before symptoms typically develop.
The trial consisted of non-hospitalized adults who indicated a high-risk or moderate-risk exposure to COVID-19 through the household or an occupational setting. They were provided the study drug or placebo by mail within 4 days of exposure. This leaves the prophylactic treatment to take place before symptoms typically develop.
The randomized placebo-controlled trial launched on March 17. The trial enrolled 821 participants from across Canada and the United States. Half of the participants received 5 days of hydroxychloroquine while the other half received 5 days of a placebo.
Out of 821 participants, COVID-19 like-illness developed in 107 (13%) participants.
Notably, polymerase-chain-reaction assay confirmation was only available for about 3% of participants. Incidence of likely COVID-19, however, did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]).
Side effects were more common in patients receiving hydroxychloroquine (40.1%) than placebo (16.8%), but no serious adverse effects (including serious heart complications) were reported.
“Our team at the University of Minnesota has just concluded the first randomized, placebo-controlled, double-blind clinical trial of hydroxychloroquine as post-exposure prophylaxis in SARS-CoV-2,” the study’s second author, Matthew Pullen, MD, said. “After examining the data of our 821 participants, we did not find a significant difference in the risk of infection following exposure in those taking hydroxychloroquine and those taking placebo. We also did not find an association between hydroxychloroquine and serious adverse effects in our study population.”
An editorial published alongside the results in the New England Journal of Medicine questioned how the results would impact clinical trials going forward.
“On June 1, 2020, ClinicalTrials.gov listed a remarkable 203 Covid-19 trials with hydroxychloroquine, 60 of which were focused on prophylaxis,” wrote Myron S. Cohen, MD, in the editorial. “An important question is to what extent the article by Boulware et al. should affect planned or ongoing hydroxychloroquine trials?”
This story originally appeared in ContagionLive!®
Four Years After COVID-19: What Has the Infection Prevention Community Learned?
March 15th 2024Four years ago today, March 15, 2020, the COVID-19 lockdown began, and since then, the world has undergone significant changes. It has been a terrifying experience for everyone, especially for the infection prevention community, both within and outside of the health care sector. However, a crucial question remains unanswered: What has the infection prevention community learned from this pandemic, and where does it go from here?
COVID-19 Harmonization: Balancing Risks and Benefits of CDC's Latest Move
March 11th 2024The CDC's recent decision to align recommendations for respiratory viruses, particularly COVID-19, has garnered support from the public and infectious disease societies. However, as the Infectious Diseases Society of America (IDSA) lends its backing to the CDC's harmonization efforts, concerns persist regarding the implications of this shift, especially considering the Omicron variant's unique characteristics and the ongoing challenges posed by COVID-19's multi-system impacts.
Voices of Resilience: Q&A With the Editor of "Corona City: Voices From an Epicenter"
March 1st 2024Step into the diverse and poignant world of "Corona City: Voices From an Epicenter" with editor Lorraine Ash, MA. In this insightful Q&A, learn about the origins of this remarkable anthology, the challenges faced in capturing raw, unfiltered narratives of the COVID-19 pandemic, and the lasting impact of these stories on readers and communities alike.
COVID-19 Realities: Beyond a Respiratory Virus, Addressing Optimism in Pandemic Management
February 28th 2024A recent commentary by Dr. Amesh Adalja in MedPage Today challenges the perception of COVID-19 as solely a respiratory virus, highlighting its broader impact on the body. This analysis questions the notion that COVID-19 should be managed like common respiratory infections, urging a closer look at vaccine effectiveness, the rise of long COVID, and the need for enhanced measures to curb the virus's spread. Let's explore the complexities of COVID-19 management and the pressing realities faced by the US and the world.