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HCQ Effective for COVID-19 in Small Randomized Trial

by Molly Walker, Associate Editor, MedPage Today

Hospitalized patients in China with COVID-19 coronavirus treated with hydroxychloroquine (HCQ), an antimalarial also used to treat autoimmune diseases, had a shorter time to clinical recovery, as well as improved pneumonia, a randomized trial found.

Patients randomized to receive hydroxychloroquine with standard treatment had a significantly shorter time to body temperature recovery of about a day, as well as a significantly reduced time to cough remission of about a day versus patients receiving only standard treatment, reported Zhan Zhang, MD, of Wuhan University in China, and colleagues.

Moreover, a larger proportion of patients in the HCQ group had improved pneumonia compared with patients in the control group (80.6% vs 54.8%), they wrote in a manuscript posted on the medRxiv preprint server.

HCQ and chloroquine for COVID-19 treatment have been in the spotlight ever since President Trump first touted their benefits in a press briefing 2 weeks ago. The FDA said it was looking into conducting randomized trials of the drug in COVID-19 patients, though some hospitals have already opted for off-label use of these agents.

One person in Arizona died after ingesting chloroquine phosphate, also sold for cleaning fish tanks, prompting the CDC to issue a warning against this practice.

Previous trials had explored in vivo activity of the drug, and one pilot study found no benefit in clinical measures or viral clearance compared with standard of care.

Still, the drug continues to be tested in ad hoc trials, including this one by Zhang and colleagues. They randomized 62 patients hospitalized with laboratory-confirmed COVID-19 infection in February. All patients received standard treatment, including oxygen therapy, antiviral agents, antibacterial agents, and immunoglobulin, with or without corticosteroids; patients in the intervention group also received oral HCQ sulfate tablets 400 mg/day on days 1-5.

Primary endpoint was time to clinical recovery, defined as “return to body temperature and cough relief, maintained for more than 72 [hours].” Mean patient age was about 45 and almost half were men, with no significant differences in the age and sex distribution between groups, the authors said.

Patients in the HCQ group had a significantly shorter time to body temperature recovery versus controls (2.2 days vs 3.2 days, P=0.0008). Similar results were seen for time to cough remission for the HCQ and control groups (2.0 vs 3.1 days, P=0.0016).

They noted four of 62 patients progressed to severe illness, all in the control group.

Two patients reported mild adverse reactions in the HCQ group, one with a rash and one with a headache.

Retinopathy is a known side effect of long-term therapy with HCQ — often seen in lupus patients who may stay on the drug for years — and patients occasionally experience arrhythmias and, more rarely, gastrointestinal reactions, cramps, and liver dysfunction. Patients should be monitored for these, but “short-term application of HCQ is relatively safe,” Zhang and colleagues wrote.

While acknowledging a need for large-scale clinical trials and other research to clarify the specific treatment mechanism and optimize the treatment plan, the authors concluded that “considering that there is no better option at present, it is a promising practice to apply HCQ to COVID-19 under reasonable management.”