What you need to know about anti-malarial drugs and COVID-19
Editor’s note: As what we know about COVID-19 evolves, so could the information contained in this story. Find our most recent COVID-19 blog posts here, and learn the latest in COVID-19 prevention at the Centers for Disease Control and Prevention.
During the coronavirus pandemic, researchers are furiously working to develop a vaccine to protect people from COVID-19. In the meantime, physicians are trying a variety of existing drugs—including anti-malarials, anti-virals and antibiotics—to see if any are effective in treating patients with this potentially life-threatening disease.
In particular, there’s been lots of hype around using anti-malarial drugs, including chloroquine and a related derivative, hydroxychloroquine, as a possible cure for COVID-19.
President Donald Trump has touted both drugs, which are already proven to treat malaria, common rheumatologic conditions and autoimmune conditions, including rheumatoid arthritis and system lupus erythematosus.
For patients with these autoimmune diseases, clinical trials have shown these drugs can improve physical function, decrease inflammation in joints and/or slow the progression of joint damage. In malaria, they’ve been shown to prevent the risk of infection from the parasite that causes the disease.
The U.S. Food and Drug Administration has authorized the emergency use of the drugs for COVID-19 when clinical trials aren’t available, despite limited and conflicting data on their use in these patients. These drugs are being considered as possible COVID-19 treatments because they may impair the release of the virus within cells, which could reduce the viral load and lead to fewer infections.
Just this week, a panel of experts convened by the National Institute of Allergy and Infectious Diseases recommended against doctors using a combination of hydroxychloroquine and the antibiotic azithromycin for the treatment of COVID-19 patients because of potential toxicities.
What do clinical trials show for these drugs to treat or prevent COVID-19?
On March 20, the International Journal of Antimicrobial Agents published the results of a small French clinical trial looking at the use of hydroxychloroquine and the antibiotic azithromycin to treat COVID-19. This study, which involved 20 patients, concluded “hydroxychloroquine treatment is significantly associated with viral load reduction/disappearance in COVID-19 patients and its effect is reinforced by azithromycin.”
However, two weeks later, the journal published a statement saying that the study “does not meet the (International Society of Antimicrobial Chemotherapy’s) expected standard, especially relating to the lack of better explanations of the inclusion criteria and the triage of patients to ensure patient safety.”
Are there any clinical trials studying these drugs for COVID-19?
There are multiple clinical trials ongoing in the United States and worldwide to evaluate the effectiveness of chloroquine and hydroxychloroquine in COVID-19 patients.
A new Veteran’s Administration study of 368 patients showed that the 97 patients who took hydroxychloroquine had a 27.8% death rate. The 158 patients who didn’t take the drug had an 11.4% death rate. Even though this isn’t a randomized, double-blind study, it’s still an important study with a larger number of participants.
But it’s important to remember that there are no double-blind, randomized controlled trials proving the effectiveness for chloroquine or hydroxychloroquine in the treatment of COVID-19. This type of clinical trial is considered the “gold-standard.”
Also of note, there are no studies indicating that people who normally take these drugs for other diseases are less likely to develop COVID-19 or are more likely to recover from it.
What are the risks of taking these drugs?
Chloroquine, which has been used since 1934, and hydroxychloroquine (since 1955), are generally well-tolerated, but a common side effect may be gastrointestinal upset. Toxic levels of the drugs, particularly over time, can lead to irreversible retinal pigmentation and blindness.
Patients may also develop severe skin rash or muscle or cardiac toxicity, characterized by muscle weakness or cardiomyopathy.
Will there be enough of these drugs to continue treating autoimmune patients and COVID patients?
Unfortunately, there have been reports of doctors and patients hoarding these medications to either treat or prevent COVID-19. Unregulated and unsupervised usage may lead to shortages of these drugs, particularly for patients with autoimmune disorders.
If patients with lupus or rheumatoid arthritis find they can’t refill their prescriptions, they can contact their primary care prescriber. A special code applied to their prescription lets the pharmacist know they’re receiving hydroxychloroquine or chloroquine for an FDA-approved indication.
Kevin Hackshaw is a rheumatologist at The Ohio State University Wexner Medical Center and an Associate Professor at The Ohio State University College of Medicine.