The drug Hydroxychloroquine has long been studied as a treatment for malaria and autoimmune diseases. When the coronavirus pandemic spread across the globe, many countries resorted to using the drug in the hopes that it would improve outcomes of hospitalized patients affected by the coronavirus disease (COVID-19).
A team of researchers, who conducted the first randomized clinical trial that tests Hydroxychloroquine as an early treatment for mild coronavirus illness, has found that the drug was no better than a placebo in patients who were not hospitalized.
Published in the journal Annals of Internal Medicine, the study has found that about 24 percent of the patients given Hydroxychloroquine had persisting symptoms over 14 days, while an estimated 30 percent of the group given a placebo also had persistent symptoms over the same period. The researchers concluded that the difference between the two was not statistically significant.
To arrive at their findings, the researchers at the University of Minnesota, conducted the study from March through May. The findings add to the evidence that the malaria drug, which was first acknowledged as a treatment based on scant data early in the pandemic, did not substantially reduce symptom severity in outpatients with early and mild COVID-19, which is caused by the pathogen severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Novel Coronavirus SARS-CoV-2 Colorized scanning electron micrograph of a cell (blue) heavily infected with SARS-CoV-2 virus particles (red), isolated from a patient sample. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. Credit: NIAID
The randomized, placebo-controlled study was conducted on 491 outpatient patients, but due to the shortage of test kits in the country, only 58 percent of the participants were tested for COVID-19. The team also revealed that five people who were given the drug were hospitalized or died because of the infection, compared with eight people given a placebo.
Of the participants, half received five days hydroxychloroquine, and the other half received five days of a placebo. They were recruited and enrolled in the study within the first four days of reporting the symptoms. About 56 percent of the patients had symptoms on the first day of the trial.
Clinicians monitored the condition of the patients for 14 days. At the end of two weeks, the team discovered that the drug had no significant effect, and it offered no advantage in relieving the symptoms of the disease or preventing its progression. Further, hospitalizations nearly the same, with 2 percent in the hydroxychloroquine group ending up being hospitalized, compared to 3 percent in the placebo group. The death rate was the same in the two groups, at 0.4 percent.
The prescriptions for Hydroxychloroquine in the United States skyrocketed between February and March, the researcher said.
Hydroxychloroquine use in COVID-19
The drug has been included in the World Health Organization (WHO)’s Solidarity Trial, which is an international clinical trial to help find an effective drug or treatment for COVID-19. On June 17, the health agency announced that it is stopping the use of Hydroxychloroquine in patients infected with the novel coronavirus due to findings that the drug did not reduce mortality of hospitalized patients when compared with the standard of care.
Meanwhile, on July 1, the U.S. Food and Drug Administration (FDA), released a report regarding the safety issues tied to the use of Hydroxychloroquine and chloroquine in patients with COVID-19. Based on the report, the FDA cautions against the use of the drug for COVID-19 outside of the hospital setting or a clinical trial due to a risk of heart rhythm problems.
On July 4, the WHO accepted the recommendation from the Solidarity Trial’s International Steering Committee to discontinue the trial’s Hydroxychloroquine and lopinavir/ritonavir arms. The committee has found that Hydroxychloroquine produces little or no reduction in deaths in hospitalized patients with COVID-19.
So far, there is still no drug or vaccine available for COVID-19, but many vaccine candidates are conducting clinical trials. The coronavirus death toll has topped 605,000, while the number of confirmed cases exceeded 14.44 million. The United States has reported more than 3.76 million confirmed cases and at least 140,000 deaths, the highest in the world.