Frequently Asked Questions
Do you test participants for coronavirus/COVID-19?
Is there any financial compensation for this study / will I be paid?
I was closely exposed to a person, but their COVID-19 test is still pending, can I enroll? I am currently asymptomatic.
I am already taking hydroxychloroquine for medical reasons, am I eligible to enroll in the study?
I am outside of the U.S., can I enroll?
I do not meet the current eligibility criteria. Can I be involved in later studies?
I completed a screening survey or emailed [email protected], and I have not heard back.
Are you enrolling pregnant or breastfeeding women?
Can I donate blood, breastmilk, saliva, or other body fluids for testing to assess antibodies if I have already recovered from COVID-19?
Does your study involve infecting healthy colunteers with coronavirus?
Are you looking at prophylaxis for those individuals who are at high-risk?
How can I help with your study?
Are you looking for additional study sites?
Where are you getting hydroxychloroquine? Pharmacies here are out/low on stock.
Does the use of hydroxychloroquine in this study on COVID-19 take away from patients who are using HCQ for other medical reasons?
Will this study examine the effects of other medications in addition to hydroxychloroquine (such as azithromycin and/or zinc)?
What dose of hydroxychloroquine are you using?
Does hydroxychloroquine cause heart problems?
The dose and duration of therapy are important. The dosing used in our UMN trial is modified from the dosing used for malaria, which gives: 800mg once, then 400mg in 6-8 hours, then 400mg once daily. Based on the target therapeutic concentration for this virus, we have increased the subsequent daily doses to 600mg. Normal dosing for rheumatoid arthritis is up to 600mg/day.
Hydroxychloroquine and chloroquine have a ~65-70 year track record of safety when used acutely for malaria treatment in the outpatient setting at the current doses. In treatment of malaria for the past 70 years, getting an EKG prior to starting treatment has not standard practice. In a 2018 review of short-term antimalarial treatment trials (n=1076 with chloroquine), no serious cardiac adverse events were reported among 35,548 participants receiving acute therapy for malaria (Haeusler). Similarly, in rheumatology, EKGs are not performed in routine practice. The average QTc change is approx +10 msec, which is not generally clinically significant. Long-term use (>1 year) has been associated with the development of cardiomyopathy and arrhythmias. Specifically, chronic use has been associated with a mean +25msec prolongation of the QT interval after a median use of 3.5 years in patients with autoimmune diseases. If one exceeds the normal dose, such as in a recent Brazilian study which used twice the normal malaria dose (at 1200mg Chloroquine base per day, equivalent to 2000mg chloroquine phosphate), then heart toxicity can occur.
Reference: Haeusler IL, Chan XHS, Guerin PJ, White NJ. The arrhythmogenic cardiotoxicity of the quinoline and structurally related antimalarial drugs: A systematic review. BMC Med. 2018;16:200. PMC6220451.
How are these clinical trials being funded?
These trials are funded by private donors and the University of Minnesota. Donors include: Jan and David Baszucki, the Alliance of Minnesota Chinese Organizations, and the Minnesota Chinese Chamber of Commerce. If you wish to contribute, please go to: http://c-fund.us/r6j