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COVID-19 Pre-Exposure Prophylaxis with Weekly Low Dose Hydroxychloroquine Clinical Trial Information


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I thought it would be helpful to spread the trial information regarding an actively enrolling nationwide pre-exposure prophylaxis with weekly low-dose hydroxychloroquine (website: covidprep.umn.edu). Neat study design with eligibility determination, enrollment, and follow-up online as well as FedEx shipment of the medication. UMN also has a post-exposure prophylaxis trial ongoing, more information at covidpep.umn.edu.
 

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This is a national, internet-based, randomized, double-blinded, placebo-controlled, prospective clinical trial examining the effectiveness of low-dose weekly hydroxychloroquine (HCQ) in preventing COVID-19 infection in high risk healthcare workers. Please find attached trial information sheet and enrollment eligibility email link. Trial information can also be found on Pre-exposure Prophylaxis for SARS-Coronavirus-2 - Full Text View - ClinicalTrials.gov. Feel free to share the trial information with your colleagues, academic connections, and through social media.

We hypothesized that weekly HCQ (same dose as the well-tolerated anti-malarial prophylactic dose) will decrease the risk of infection, and if infected, decrease the severity of the infection. This hypothesis is based on HCQ's mechanism of action on the endosomal entry pathway of SARS-CoV-2, preliminary clinical data of HCQ in COVID-19 treatment, in vitro antiviral properties, HCQ's high volumes of distribution resulting in high target organ (e.g. lung) steady state concentrations, and HCQ's known safety profile at its weekly dosage.

The trial will randomize participants into two treatment arms (once weekly dosing or twice weekly) and one placebo arm. Prophylaxis duration will be up to 12 weeks. Recruitment goal is set at 3,500 participants. Eligibility determination, enrollment, and weekly follow-up as well as post-trial follow-up will all be performed online, with no clinic visit or direct human contact. Eligible participants will receive overnight shipment of the medication vs. placebo. Primary endpoint is clinical or laboratory diagnosis of COVID-19.

Healthcare workers at high risk of COVID-19 exposure will be included in the study. People with active COVID-19 or suspected infection will be excluded and re-directed to other ongoing clinical trials. People with retinal disease, chronic kidney disease, G6PD deficiency, concurrent use of HCQ, HCQ allergy, on medication with potential QT prolongation, or on medication with known significant drug-drug interaction will be excluded.

We would like to know the answer sooner rather than later. And you can help us by spreading the trial information. If HCQ were truly prophylactic, we will be protecting our brave front-liners not only in the hospital but also from community asymptomatic spread. I would think protecting our critical medical staff is just as important as procuring PPE, ventilators, and bed capacity.

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This is Dr. David Boulware's (one of the lead investigators on the trial) tweet today regarding the COVID PrEP trial: "Nationwide #COVID hydroxychloroquine prophylaxis trial for high risk healthcare workers or #FirstResponders Go to http://covidprep.umn.edu for more information. #MedTwitter #CriticalCare Over 1000 participants enrolled in first week. "

 

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Please read carefully about the inclusion and exclusion criteria. UMN have two HCQ prophylaxis trials ongoing:

 

1) Pre-exposure prophylaxis trial (PrEP). This is for high risk healthcare personnel/first responders without confirmed diagnosis or symptomatic complaints. The website for this trial is covidprep.umn.edu.

 

2) Post-exposure prophylaxis trial (PEP). This is for anyone with known exposure to COVID-19 positive patients within 4 days. The website for this trial is covidpep.umn.edu.

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22 hours ago, cinntsp said:

Interesting.  I signed up because what the heck.  We've stopped using HCQ on our patients on ID's recommendations due to some recent data that came out.

Yeah. A lot of places and other ongoing/upcoming clinical trials are using daily high dose. That dose has known significant side effects, including but not exclusive to retinopathy and QT prolongation. The dose used in this UMN Pre-Exposure Prophylaxis trial is a weekly low dose regimen with a long established safety profile. We hope to find out whether HCQ has prophylactic effect at this dosing regimen soon.

Edited by lncpeter
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http://covidprep.umn.edu with some more information regarding the study:

Pre-Exposure Prophylaxis for Coronavirus

The University of Minnesota, in collaboration with Vanderbilt University and Oregon Health and Science University, is conducting a research study to determine if taking a medication called hyroxychloroquine (Plaquenil) can help in preventing COVID-19 disease (commonly referred to as coronavirus). 

We are looking for participants who are healthcare workers in settings that are high risk for exposure to COVID-19:

  • Persons primarily working in Emergency Departments (physicians, nurses, ancillary staff, triage personnel)
  • Persons primarily working in Intensive Care Units (physicians, nurses, ancillary staff, respiratory therapists)
  • Persons performing aerosol generating procedures (ex. anesthesiologists, nurse anesthetists (CRNAs))
  • First responders (ex: EMTs, paramedics)
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1 hour ago, EMEDPA said:

Will be interesting to see the study design... Wonder who got the Plaquenil, if it was the sicker of the patients vs provider preference? Also where'd the other 100+ patients go? Was there any matching?

I'm the last one to believe in this medication, but I'm also a little tired of rando poorly designed "studies" popping up. Gives just as much ammo to the uneducated proponents as it does those against

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19 minutes ago, MediMike said:

Will be interesting to see the study design... Wonder who got the Plaquenil, if it was the sicker of the patients vs provider preference? Also where'd the other 100+ patients go? Was there any matching?

I'm the last one to believe in this medication, but I'm also a little tired of rando poorly designed "studies" popping up. Gives just as much ammo to the uneducated proponents as it does those against

The ivermectin study seems a bit more promising as does the Gilead trial. 

https://www.webmd.com/lung/news/20200407/parasite-drug-shows-early-promise-against-covid-19

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15 hours ago, Cideous said:

While I would love for the people to stop talking about this drug, they are now going to test it for early use, prophylaxis, which will be inconclusive, or they will say it works because people so badly want it to, because the n wound have to be in the 100 thousands range to detect anything significant.

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Nationwide COVID-19 hydroxychloroquine prophylaxis trial (http://covidprep.umn.edu) for high risk healthcare workers and first responders. 1300+ enrolled so far. Looking for more participants! If HCQ were truly prophylactic, we will be protecting our brave front-liners not only in the hospital but also from community asymptomatic spread. Please help us by spreading the trial information.

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13 hours ago, cinntsp said:

I got a little nauseous after the first dose, but otherwise no problems.  My heart seems to be beating normally still, so hopefully that means my QT is doing a-okay!

Good to know. GI side effects can usually be minimized if taken with a meal or with milk. Also, you could split up the dose by taking one tab in the morning and the other at night. Stay well!

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