A clinical study will begin in Korea soon to compare HIV drug Kaletra (ingredient: lopinavir/ritonavir) with malaria treatment Oxiklorin (hydroxychloroquine) in treating patients with mild symptoms of the new coronavirus infection.
According to the government’s clinical trial information site, the Ministry of Food and Drug Safety approved Asan Medical Center to go ahead with the investigator-initiated clinical trial on Friday.
|AbbVie's HIV treatment Kaletra (left) and Elyson Pharmaceutical's antimalarial treatment Oxiklorin,|
The open-labeled trial will randomly administer Kaletra, hydroxychloroquine, and no treatment to COVID-19 patients with mild symptoms.
The health authorities recommend Kaletra and hydroxychloroquine as the first-line treatment for COVID-19 patients. As local physicians rarely use hydroxychloroquine, most COVID-19 patients in Korea are receiving Kaletra, media reports said.
However, a recent report by Chinese researchers on the New England Journal of Medicine said Kaletra showed no treatment benefit for COVID-19 patients with severe symptoms.
The report diverted attention towards hydroxychloroquine.
In contrast to the study on Kaletra, a recent French paper showed that hydroxychloroquine had an antiviral effect against COVID-19 in confirmed cases.
According to the French study released on the International Journal of Antimicrobial Agents, the official journal of the International Society of Antimicrobial Chemotherapy, hydroxychloroquine showed a statistically meaningful effect for COVID-19 patients from the third day of administration, compared to the untreated group.
Besides, hydroxychloroquine in combination with an antibiotic, azithromycin, enhanced the efficacy. The combo therapy group tested negative 100 percent in the nasopharyngeal PCR test from the fifth day of administration, according to the study.
The patent of hydroxychloroquine already expired. With its affordable price and easy supply, the drug has drawn attention since the initial outbreak of COVID-19. Doctors in other countries have cited the drug’s strong establishment of safety profile for decades as the treatment’s significant advantage.
Hydroxychloroquine proved its antiviral effect through in vitro clinical results on COVID-19 patients. In China, the drug is undergoing a trial on COVID-19 patients.
The comparative study at Asan Medical Center will be the first to administer hydroxychloroquine to COVID-19 patients.
The study will use Oxiklorin by Elyson Pharm for the test of hydroxychloroquine.
In Korea, 26 hydroxychloroquine-containing medicines received authorization, and 15 of them supplied by five domestic drugmakers are receiving the health insurance benefit.