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HCQ fails as pre-exposure prophylaxis for COVID-19 in HCP

 


Hydroxychloroquine (HCQ) had no clinical benefit because COVID-19 pre-exposure prophylaxis was performed in a small sample of hospital-based healthcare professionals. Randomized trials were stopped early due to found waste.

Participants randomized to receive HCQ daily for 8 weeks were not significantly different in infection rates from participants randomized to receive placebo (6.3% vs. 6.6%, respectively). P > 0.99), reported by Ravi Amaravadi, MD, and colleagues at the University of Pennsylvania, Philadelphia.

There was no difference in median changes in QTc baseline, but overall adverse events were significantly more common in the HCQ group than in the placebo group, the authors wrote in an online study: I am. JAMA Internal Medicine..

They said the trial enrolled 123 participants in the planned 200, but ended early due to waste. Data safety monitoring as 4 HCQ participants and 3 placebo participants changed to positive SARS-CoV-2 status when 100 participants completed the study after the second interim analysis The committee recommended early termination of the study.

HCQ has recently been out of the news, but researchers have pointed out studies investigating the drug: Post-exposure prophylaxis with a 5-day course. Although no clinical benefit was shown, the authors found that the key limitation of this study, the primary outcome, was “infection-consistent symptoms” and that most patients had a reverse transcriptase-polymerase chain reaction (RT- He pointed out that he had not been evaluated for infection by PCR). )test. The researchers said this raised concerns about Type II errors from asymptomatic participants.

They daily as pre-exposure prophylaxis for hospital-based healthcare professionals through RT-PCR testing of nasopharyngeal swabs and serological antibody testing from participants at baseline and at 4 and 8 weeks of treatment. I tried to find out the HCQ of.

Hydroxychloroquine prophylaxis and treatment (PATCH) trials of COVID-19 were conducted at two teaching hospitals in Philadelphia from April 9th ​​to July 14th. The hospital had a unified policy regarding the use of personal protective equipment such as masks, eyewear and gowns by healthcare professionals. Screen patients for COVID-19 symptoms.

Eligible participants include doctors, nurses, certified nursing assistants, emergency technicians, and respiratory therapists who worked more than 20 hours a week in hospital-based units and were infected with SARS-CoV-2 in 2 weeks. I had no medical history or COVID-19 symptoms. Before registration.

The main result was the rate of conversion to SARS-CoV-2 positive by nasopharyngeal swabs during the 8-week study.

The first 132 randomized participants had a median age of 33 years, nearly 70% female and 83% white. More than half worked in the emergency department, while 37% worked in the internal ward. About two-thirds of the participants were nurses and 21% were doctors.

Overall, the authors said that 64 participants in the HCQ group and 61 in the placebo group were able to assess the primary outcome, but 12 HCQ participants and 10 placebo participants were tested early. Treatment was discontinued.

There were eight infections throughout the study and none required hospitalization. All were either asymptomatic or “completely recovered from a mild illness.”

At the end of the study period, the authors stated that four SARS-CoV-2 positive participants treated with HCQ and three treated with placebo had IgG antibodies against SARS-CoV-2.

The safe group consisted of 65 participants in each group who took at least one study drug, with a significantly higher rate of adverse events in those who took hydroxychloroquine and placebo (45% vs. 26%, respectively). .. P= 0.03). HCQ participants also reported significantly increased diarrhea compared to placebo.

However, there was no difference in cardiac events such as syncope and arrhythmia, and there was no significant difference in QTc between the two groups.

Data limits include insufficient detection power due to the small sample size. This means that researchers “cannot rule out the possibility of undetected modest protective effects of hydroxychloroquine.” In addition, the team was unable to quantify the frequency or timing of participants’ exposure to SARS-CoV-2.

“Daily use of hydroxychloroquine cannot be recommended. [healthcare workers] To prevent COVID-19, “the authors concluded.

  • Author['full_name']

    Molly Walker Deputy Editor-in-Chief for Infectious Diseases on MedPage Today. She has a passion for evidence, data and public health. To follow

Disclosure

The study received charitable donations from Leonard and Madrin Abramson, Mark and Cecilia Fondahide.

Amaravadi is a scientific founder and holds a stake in Pinpoint Therapeutics. He is a co-inventor of a patent for autophagy inhibitors of cancer and a consultant for cancer-related programs at Sprint Biosciences, Deciphera, and Immunaccel. The co-authors disclosed support from Becton Dickinson, Gilead, and royalty income from patents licensed to Novartis unrelated to hydroxychloroquine.

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