COVID-19 PEP Study

Frequently Asked Questions

Where can I learn about the study findings?

The study findings announcement is available here.

I heard that a recent study found that hydroxychloroquine does not work to prevent the coronavirus disease. Is that true and why are you continuing to test hydroxychloroquine?

A recent study by David Boulware and colleagues tested hydroxychloroquine to prevent coronavirus disease. Overall they found no effect of hydroxychloroquine on prevention. They did find that among household contacts, hydroxychloroquine prevented coronavirus disease in 31% of people and the effect was stronger if medication was started earlier (possibly 50% fewer infections) but the study was not designed to look at household members so we are not certain about that result. Also, participants were not tested in the study and only reported results if they were tested outside the study. Because our study is designed to measure the effect of hydroxychloroquine to prevent coronavirus disease within households and we test all participants every day, it is critical that we continue in order to test hydroxychloroquine for coronavirus disease prevention.

Importantly, the Boulware et. al. trial found that hydroxychloroquine was safe.

Is this study safe?

The Data and Safety Monitoring Board (DSMB) is an independent group of clinical research experts and patient advocates who monitor the progress of a clinical trial and review safety and effectiveness data while the trial is ongoing. The COVID-19 PEP Study was reviewed on May 28, 2020, and no safety concerns were identified. The DSMB recommended continued recruitment and enrollment. More. Additionally, this study is approved by the Western Institutional Review Board (WIRB).

The study’s number is NCT04328961.

Does recent research in The Lancet regarding HCQ/CQ in COVID-19, and the temporary suspension then restart of enrollment in the HCQ arm of the WHO SOLIDARITY trial, mean that all HCQ trials are not safe?

The World Health Organization (WHO) recently paused the hydroxychloroquine (HCQ) arm of the SOLIDARITY trial in order to review The Lancet research published by Mehra et al. on May 22, 2020. The Lancet has since retracted the Mehra et. al. paper because the data used for the analysis could not be verified. Also, the World Health Organization restarted the hydroxychloroquine arm of the SOLIDARITY trial. Multiple clinical trials have reviewed their study data and found that hydroxychloroquine trials are safe to continue.

In our study we will be able to assess the efficacy and safety of hydroxychloroquine in a rigorous manner. We are recruiting participants while they are well enough to be at home and when the study medication can be effective.

Hydroxychloroquine has been used for more six decades and has a good safety profile. Laboratory data supports hydroxychloroquine activity against the coronavirus and is encouraging. Rigorously conducted clinical trials, which closely monitor safety, are the most reliable way to learn about hydroxychloroquine efficacy to prevent and treat COVID-19. We urgently need multiple, rapid, high quality studies to evaluate hydroxychloroquine for COVID-19 prevention and treatment.

Three studies in India reported that hydroxychloroquine works for preventing coronavirus infection and the Indian government is expanding hydroxychloroquine use to protect essential workers. Why is the COVID-19 PEP Study continuing to enroll participants?

While the India study’s results are encouraging, those studies are observational studies. We don’t know whether strategies to prevent infection, such as using personal protective equipment, could explain the findings. Similar to the case of observational studies that show no effect of hydroxychloroquine, rigorous clinical trials – such as the COVID-19 PEP and Treatment trials – are needed to evaluate whether hydroxychloroquine works to prevent and treat COVID-19.

I don’t feel well and am worried I have coronavirus. Can the COVID-19 PEP Study help me?

The COVID-19 PEP Study is a clinical trial, and not a clinical service. The purpose is to answer if hydroxychloroquine (HCQ) works to prevent people getting COVID-19 when taken by individuals who have had recent exposure to someone with the virus, through conducting a carefully controlled study. The COVID-19 PEP Study is not a substitute for checking in with your healthcare provider. If you don’t feel well or suspect you might have COVID-19, stay home, contact your healthcare provider, and follow public health guidance.

I submitted my study application a while ago. Will I get a response?

All applications are carefully reviewed, and only those participants who have been accepted for the study will receive a response. If you have not received a response to your application within two days of submission, this indicates that your application has not fit with the current study needs and availability.

I saw that the drug remdesivir can be used for coronavirus/COVID-19 treatment. Why are you not testing remdesivir in your study?

Remdesivir is an investigational broad-spectrum antiviral that is administered via daily infusion and is used to treat patients with severe COVID-19 who are admitted to the hospital. This study aims to test medications that can be administered orally at home. Similar to remdesivir, early data for hydroxychloroquine are encouraging and clinical trials, such as this one, are needed to test whether it works.

The US FDA has recently issued a warning on chloroquine and hydroxychloroquine. How does this study address this?

Our study differs from what the FDA is warning about in two ways: First, the dose of hydroxychloroquine in our study is lower than other studies. At the dose we given in this study, hydroxychloroquine has been used safely for decades to treat people with autoimmune disorders. Second, participants in our study are at home and generally well. In the other study, participants were hospitalized with severe disease. Importantly, in the PEP Study, participants can reach out to the study team for guidance on side effects.

The FDA  encourages clinical trials to answer important questions on whether hydroxychloroquine works against COVID-19. Within the context of a clinical trial, we are able to rigorously measure its impact on health.

I heard that a study in Brazil was stopped early due to side effects of chloroquine. Is that something to be concerned about?

No. The PEP Study is different in important ways from the Brazil study that was stopped early. First, we are testing hydroxychloroquine, which is safer than chloroquine. Second, the dose of hydroxychloroquine is much lower in our study – 66% lower – than the other study. At the dose we are using in this study, hydroxychloroquine has been proven to be used safely for decades to treat people with autoimmune disorders. Third, participants in our study are at home and generally well. In the other study, participants were hospitalized with severe disease and received other antibiotics which could cause adverse effects. Importantly, in the PEP Study, participants can reach out to the study team for guidance on side effects.

I have been accepted to the study and received and followed instructions from my healthcare provider. Will my sample be tested for coronavirus? Can I know the result?

We will be testing COVID-19 PEP Study research samples for COVID-19. Now there are clearer guidelines for COVID-19 results that can be given to participants under a new lab certification received on March 19. Participants who signed a consent form are eligible to receive COVID-19 results.

What is the incubation time for COVID 19?

Typically 5-7 days.

Why the excitement about hydroxychloroquine?

This particular drug first made waves when a small study out of France noted that patients who had COVID-19 had less of the SARS-CoV-2 virus in their blood after taking hydroxychloroquine in combination with antibiotic azithromycin (Zithromax). Another study of 100 patients in China showed similar results. Although the data were promising, these studies were not controlled clinical trials, a quality standard in medical research. For that reason, more research needs to be done to confirm the effectiveness of the drug for this particular disease.

What is the basis for studying hydroxychloroquine(HCQ) for COVID post-exposure prophylaxis?

Hydroxychloroquine (HCQ) is approved for the suppressive treatment and treatment of acute attacks of malaria, the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis, and is safe and well-tolerated.HCQ has antiviral activity against coronaviruses, including the one that causes COVID-19. Pharmacologic modelling suggests that HCQ prophylaxis could prevent SARS-CoV-2 infection after exposure and/or shorten the duration of viral shedding, if someone becomes infected. One advantage of studying HCQ is that it is already approved and available so could be implemented quickly if it is shown to be effective in humans exposed to COVID-19.

Does hydroxychloroquine (HCQ) work to treat COVID?

While the drug hydroxychloroquine has generated some buzz for its potential benefits in treating COVID-19, we don’t yet know if it works. The drug is an existing medication that’s been used to treat malaria and autoimmune disorders, but the research on its use for COVID-19 is still limited.

A small study in France suggests that HCQ might have clinical benefit to treat people who are sick with COVID 19. Additional studies are underway to provide more data about HCQ for treatment of COVID 19.

Why are you studying hydroxychloroquine (HCQ) compared to a placebo?

There isn’t enough evidence to know that HCQ is effective in preventing COVID 19 disease. It is very important to find this out because it could have implications not just in the US but globally. It is not a good idea for people to take HCQ if it does not work to reduce their chances of getting sick and/or shedding the virus. The best way to know whether it works is to compare it to something that does not work against COVID-19, and that gives us the most reliable information without bias.

Should the public buy hydroxychloroquine?

If you’re not currently taking hydroxychloroquine for an autoimmune disorder or other condition, we urge you to avoid stockpiling this drug. Doing so can create a shortage for those who rely on it for their quality of life. Taking hydroxychloroquine without medical supervision can also lead to improper dosing and health complications, including hospitalization or death.