lncpeter Posted April 16, 2020 Share Posted April 16, 2020 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. 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. Quote Link to comment Share on other sites More sharing options...
lncpeter Posted April 17, 2020 Author Share Posted April 17, 2020 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. " Quote Link to comment Share on other sites More sharing options...
cinntsp Posted April 18, 2020 Share Posted April 18, 2020 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. Quote Link to comment Share on other sites More sharing options...
lncpeter Posted April 19, 2020 Author Share Posted April 19, 2020 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. Quote Link to comment Share on other sites More sharing options...
lncpeter Posted April 19, 2020 Author Share Posted April 19, 2020 (edited) 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 April 19, 2020 by lncpeter Quote Link to comment Share on other sites More sharing options...
lncpeter Posted April 21, 2020 Author Share Posted April 21, 2020 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) Quote Link to comment Share on other sites More sharing options...
Moderator EMEDPA Posted April 21, 2020 Moderator Share Posted April 21, 2020 https://www.cnn.com/2020/04/21/health/hydroxychloroquine-veterans-study/index.html Quote Link to comment Share on other sites More sharing options...
MediMike Posted April 21, 2020 Share Posted April 21, 2020 1 hour ago, EMEDPA said: https://www.cnn.com/2020/04/21/health/hydroxychloroquine-veterans-study/index.html 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 Quote Link to comment Share on other sites More sharing options...
Moderator EMEDPA Posted April 21, 2020 Moderator Share Posted April 21, 2020 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 1 Quote Link to comment Share on other sites More sharing options...
cinntsp Posted April 22, 2020 Share Posted April 22, 2020 I received my HCQ from the trial today. Wish me luck! 1 Quote Link to comment Share on other sites More sharing options...
Cideous Posted April 22, 2020 Share Posted April 22, 2020 It doesn't work...the end. https://www.huffpost.com/entry/hydroxychloroquine-study-finds-more-deaths-no-benefit_n_5e9f482ec5b660af08adeab8 1 1 Quote Link to comment Share on other sites More sharing options...
Moderator LT_Oneal_PAC Posted April 22, 2020 Moderator Share Posted April 22, 2020 15 hours ago, Cideous said: It doesn't work...the end. https://www.huffpost.com/entry/hydroxychloroquine-study-finds-more-deaths-no-benefit_n_5e9f482ec5b660af08adeab8 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. 2 Quote Link to comment Share on other sites More sharing options...
Moderator LT_Oneal_PAC Posted April 22, 2020 Moderator Share Posted April 22, 2020 16 hours ago, cinntsp said: I received my HCQ from the trial today. Wish me luck! Good luck! Quote Link to comment Share on other sites More sharing options...
Moderator LT_Oneal_PAC Posted April 22, 2020 Moderator Share Posted April 22, 2020 19 hours ago, EMEDPA said: 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 Way safer too Quote Link to comment Share on other sites More sharing options...
Moderator EMEDPA Posted April 22, 2020 Moderator Share Posted April 22, 2020 3 hours ago, LT_Oneal_PAC said: Way safer too yup. Have taken before after coming home from Haiti. Quote Link to comment Share on other sites More sharing options...
lncpeter Posted April 23, 2020 Author Share Posted April 23, 2020 On 4/21/2020 at 7:30 PM, cinntsp said: I received my HCQ from the trial today. Wish me luck! Good luck! Quote Link to comment Share on other sites More sharing options...
lncpeter Posted April 23, 2020 Author Share Posted April 23, 2020 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. Quote Link to comment Share on other sites More sharing options...
cinntsp Posted April 27, 2020 Share Posted April 27, 2020 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! 1 Quote Link to comment Share on other sites More sharing options...
lncpeter Posted April 27, 2020 Author Share Posted April 27, 2020 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! Quote Link to comment Share on other sites More sharing options...
lncpeter Posted April 30, 2020 Author Share Posted April 30, 2020 Quote Link to comment Share on other sites More sharing options...
Moderator LT_Oneal_PAC Posted April 30, 2020 Moderator Share Posted April 30, 2020 On 4/30/2020 at 11:09 AM, lncpeter said: What N are you looking to have? Quote Link to comment Share on other sites More sharing options...
lncpeter Posted May 6, 2020 Author Share Posted May 6, 2020 On 4/30/2020 at 4:05 PM, LT_Oneal_PAC said: What N our you looking to have? We are aiming for n=3,500! 1 Quote Link to comment Share on other sites More sharing options...
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