Study of Hydroxychloroquine vs. COVID-19 Planned for SLE Patients
Lupus Therapeutics, an affiliate of the Lupus Research Alliance (LRA), announced that it is working to design and run a clinical trial into whether hydroxychloroquine and other therapies for systemic lupus erythematosus (SLE) can prevent or ease symptoms of COVID-19 in SLE patients.
“This initiative is being done in response to reports that hydroxychloroquine and perhaps other immuno-suppressive agents taken by lupus patients may offer some benefit against COVID-19,” Albert Roy, Lupus Therapeutics’ executive director, said in a press release.
The study will be conducted in collaboration with Lupus Therapeutics’ Lupus Clinical Investigators Network (LuCIN), which includes 57 of the most prestigious academic medical centers in the U.S. and Canada, and follows about 20,000 people with SLE.
With patients’ broad use of medications that include hydroxychloroquine, the LRA aims to assess whether taking such treatments lowers the risk of infection and/or eases COVID-19 severity among people with SLE.
Anecdotal data from several LuCIN’s academic centers suggest this might be the case.
Daniel J. Wallace, MD, of the Cedars-Sinai Medical Center in Los Angeles, and a member of LRA’s board of directors, reported only one lupus patient among more than 1,000 admissions and screenings for COVID-19 to date. He also has found no COVID-19 cases among the 800 lupus patients he regularly follows.
“We are in early stages and it is unclear what our results will find — whether these drug therapies alone, self-quarantining, or a combination of both — are having the most impact” on COVID-19 infection with lupus, Roy added.
The LRA said it will keep the SLE community posted about the progress of “this highly relevant study.”
Originally used to prevent or treat malaria, hydroxychloroquine (sold under the brand names Plaquenil and, in some countries, Quineprox, among others) is the most commonly prescribed treatment for SLE. Its use is associated with reduced disease activity, fewer SLE flares, slower disease progression, and an overall lower mortality, among other benefits.
Based on small studies in China and France, hydroxychloroquine and its related molecule chloroquine (also used to treat malaria and SLE; brand names include Aralen) are being investigated worldwide for their potential to treat COVID-19.
A large clinical trial has been launched by the World Health Organization to better assess their benefit against the new coronavirus. These therapies’ use was authorized by the U.S. Food and Drug Administration to treat hospitalized adults and adolescents (weighing at least 50 kg or 110 pounds) with COVID-19 who are unable to participate in a clinical study.
This increased demand for hydroxychloroquine and chloroquine has raised concerns about the risk of supply shortages for people regularly taking these treatments for SLE and other diseases.
Such shortages have already started to occur, according to the LRA release, a problem that could be aggravated if these treatments are found to be effective against COVID-19.
In light of these concerns, the Lupus Foundation of America (LFA) said recently that it is working to ensure that people with SLE will be protected from a disruption in access to these medications.