Frequently Asked Questions

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Do you test participants for coronavirus/COVID-19?

Unfortunately, our study is solely online and survey-based and we are not performing laboratory testing at this time. Please contact your local primary care provider or state department of health for assistance on how to obtain a COVID-19 test.

Is there any financial compensation for this study / will I be paid?

We do not offer compensation for this study. There is no charge to participate in the trial. The study medicine is provided free of cost.

I was closely exposed to a person, but their COVID-19 test is still pending, can I enroll? I am currently asymptomatic.

At this time, you are not eligible to enroll unless your contact is confirmed to have COVID-19 and your exposure was within 4 days from the date of enrollment. We understand test results can be delayed and this may limit eligibility. If your contact's test comes back positive OR if you develop symptoms after your exposure and are within the first 4 days of symptom onset, you may retake the screening survey to reassess your eligibility.

I am already taking hydroxychloroquine for medical reasons, am I eligible to enroll in the study?

Unfortunately not. We are not actively recruiting those persons already taking hydroxychloroquine on a regular basis. Taking hydroxychloroquine or chloroquine is an exclusion criterion for this study, and taking more would likely be dangerous.

I am outside of the U.S., can I enroll?

Currently, we are only enrolling participants in the United States and Canada for regulatory reasons. If you reside in Canada, please visit http://www.covid-19research.ca for more information on how to enroll in Quebec, Ontario, Manitoba, or Alberta.   We are pleased that Puerto Rico is part of the United States, and we would welcome participation. Persons in Guam or U.S. overseas territories would expect to have limitations with two-day shipping.

I do not meet the current eligibility criteria. Can I be involved in later studies?

While your symptoms may preclude you from being involved in this particular study, we may be interested in having you participate in offshoot studies. You can fill out this survey, and we may use your contact email to reach out to you in the event we launch a new trial you may be interested in.

I completed a screening survey or emailed [email protected], and I have not heard back.

Please check your spam folder for an email. The responses are instantaneous automated responses and should have been received within ~2 minutes of your survey completion or original email.

Are you enrolling pregnant or breastfeeding women?

Yes, pregnant and breastfeeding women are allowed to enroll.

Can I donate blood, breastmilk, saliva, or other body fluids for testing to assess antibodies if I have already recovered from COVID-19?

Unfortunately, our study is solely online/survey-based, and we are not performing laboratory testing at this time.

Does your study involve infecting healthy colunteers with coronavirus?

No. There is no part of our study that proposes infecting persons with SARS-CoV-2 virus. That would be highly unethical.

Are you looking at prophylaxis for those individuals who are at high-risk?

Yes! We have started a pre-exposure prophylaxis trial using hydroxychloroquine in those at high risk of infection (healthcare workers and first responders). For more information, email us at "[email protected]" or visit our website at COVID-19 Pre-exposure Prophylaxis Clinical Trial

How can I help with your study?

One of the best things you can do to help us at the moment is simply to spread the word about the study to those who may qualify for enrollment. Feel free to share our patient information sheet and link to our website with friends, family, colleagues, and patients.

Are you looking for additional study sites?

We are not currently recruiting additional formal study sites; however, anyone can participate (if eligible).
This is a national, internet-based study. Anyone can participate anywhere in the US. The trial is attempting to be conducted as quickly as possible, thus we are avoiding inter-institutional contracts, IRB reliance agreements, and other paperwork that would slow down the conduct of the trial or stop people from participating --- while paperwork is completed.

Where are you getting hydroxychloroquine? Pharmacies here are out/low on stock.

Hydroxychloroquine is being donated from Rising Pharmaceuticals. This is not a commercial source. In Canada, the study drug was NOT obtained from any pre-existing pharmacy supply chain and was obtained directly from Apotex for research purposes.

Does the use of hydroxychloroquine in this study on COVID-19 take away from patients who are using HCQ for other medical reasons?

No. This study drug was donated from Rising Pharmaceuticals for research purposes. This does not take away from any commercial supply.

Will this study examine the effects of other medications in addition to hydroxychloroquine (such as azithromycin and/or zinc)?

No. Safety is a very important consideration for this study. There are known increased risks in combining multiple medications (e.g. heart rhythm problems) with unknown benefit. The U.S. FDA and Health Canada both thought this combination would be too risky in a prevention trial. For a person hospitalized with coronavirus infection, this may be an acceptable risk in a monitored hospital setting, but not in a prevention trial.
It is important to note that there is no convincing scientific evidence at this time to indicate that any medication, alone or in combination, is effective at improving outcomes from COVID-19. While some small observational studies and anecdotal reports of clinical successes exist, these are not supported by clinical trials, and thus have not widely been adopted into guidelines. We hope this randomized control trial will help us understand if hydroxychloroquine alone, compared with placebo, is effective in preventing COVID-19 disease or reducing symptom duration.

What dose of hydroxychloroquine are you using?

Information on the treatment regimen can be found at ClinicalTrials.gov

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