Hydroxychloroquine prophylaxis in healthcare workers study

Hydroxychloroquine didn’t know it was going to have such a year. The once limited use drug is on the minds of millions across the globe. While there are strong opinions on either side of the argument for its use in COVID19, there’s little to actually hold these beliefs up. Which is why the need for evidence is so desperate. We can determine, in an acceptable scientific manner, whether the benefits of hydroxychloroquine are outweighed by the risks – or vice versa.

Aside from just evaluating the evidence, we as healthcare professionals can play a larger role in this research. By becoming the subjects. In this research study from the University of Minnesota, the role of hydroxychloroquine is being assessed in healthcare workers or household contact. These researchers are specifically asking whether post-exposure prophylaxis with hydroxychloroquine can prevent progression development of symptomatic COVID19 disease after known exposure to the SARS-CoV2 virus. They are also assessing whether preemptive therapy with hydroxychloroquine can prevent the progression of persons with known symptomatic COVID19 disease, preventing hospitalization.

This study is seeking to enroll healthcare workers with a known diagnosis or known exposure within 4 days to confirmed cases. This study is also open to the household contacts of these healthcare workers in the USA. The study subjects can be either asymptomatic or symptomatic provided they can consent to participate.

However, not all healthcare workers may be able to participate. Here are the key exclusion criteria:

  • Current hospitalization
  • Allergy to hydroxychloroquine
  • Retinal eye disease
  • Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
  • Known chronic kidney disease, stage 4 or 5 or receiving dialysis
  • Weight < 40 kg
  • Known Porphyria
  • Current use of: hydroxychloroquine, flecainide, amiodarone, digoxin, procainamide, or propafenone)

The primary completion date is April 21, 2020 and the final study completion date is May 12, 2020. So time is of the essence if you feel you meet the inclusion criteria.

For information on how to participate in the research trial, please email covid19@umn.edu for instructions. This email address will generate an auto-response for the information needed to enroll.

This study is a placebo-controlled trial. Patients randomly assigned to the hydroxychloroquine arm will receive hydroxychloroquine 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days. Those assigned to placebo will receive a matched placebo with instructions to take 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days

The primary outcome for this study is the incidence of COVID19 disease among those who are asymptomatic at trial entry. There are numerous secondary outcome measures, but key measures include incidence of hospitalization within 14 days, the incidence of death within 90 days, the incidence of confirmed sars-cov-2 detection within 14 days, the incidence of symptoms compatible with covid19 (possible disease) within 90 days, and incidence of all-cause study medicine discontinuation or withdrawal within 14 days.

We can all agree there is limited evidence regarding any drug with COVID19. But as we stand, there are tens of thousands of patients who have already had the disease and still have limited knowledge of what’s going on. We simply cannot afford to wait for robust studies with elegant methods and well-controlled protocols. We have to make it work with the situation we’re in. This opportunity to participate in this study is critical to the ongoing fight against this enemy.

For complete study details, see the clinicaltrials.gov listing.

Hydroxychloroquine drug interactions previously discussed here.