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.
This trial has an enrollment number planned at 3500. It has 1400+ participants enrolled so far. Enrollment will likely be active for another month, until end of May (5/31/2020).
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. 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 FedEx 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.
*Side note: UMN also has a post-exposure prophylaxis trial ongoing, more information at covidpep.umn.edu.
This trial has an enrollment number planned at 3500. It has 1400+ participants enrolled so far. Enrollment will likely be active for another month, until end of May (5/31/2020).
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. 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 FedEx 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.
*Side note: UMN also has a post-exposure prophylaxis trial ongoing, more information at covidpep.umn.edu.
