Merck, an American pharmaceutical company that has applied for emergency use approval to the U.S. Food and Drug Administration (FDA), is attracting attention as it includes the criteria for prohibiting sexual intercourse for participation in the clinical trial of Molnupiravir, an oral antiviral drug for COVID-19.
According to the US National Institutes of Health (NIH) clinical trial information disclosure on the 7th (local time), Merck has specified the prohibition of sexual intercourse as a limit to the eligibility criteria for clinical participation of this drug.
For men, Merck said, “they must agree to maintain abstinence during the period of the drug and at least four days after the last dose, and to agree to use contraception.” For women, it should be ‘not pregnant or breastfeeding, and there should be no possibility of being pregnant’.
In addition, Merck also said that △ some cases with kidney disease △ some HIV-infected patients who showed a stable response to antiviral therapy △ some history of liver cirrhosis, end-stage disease, hepatocellular carcinoma, hepatitis B and hepatitis C △ platelet count within 5 days Patients with less than 100,000/μL (microliter) or platelet transfusion were excluded from the clinical trial.
Professor Simon Clark, from the University of Reading, UK, said: “It is worth noting that clinical participants were instructed to refrain from sexual intercourse or to use contraception. Because there is a possibility.”
Regarding the treatment of COVID-19 with this drug, “It would be good to prevent 50% of patients from worsening to a serious condition, but the hospitalization rate is still high even after taking the drug,” he said. can’t,” he said.
On the 1st, Merck drew attention by announcing the interim results of the phase 3 clinical trial that the administration of molnupiravir reduced the hospitalization rate and mortality rate of COVID-19 patients by half. Merck said that as a result of a clinical trial on 775 people with mild or severe COVID-19 who had been infected within 5 days, only 7.3% of patients taking molnupiravir were admitted to the hospital, and there were no deaths.
Meanwhile, the government announced on the 5th that it is negotiating with Merck, Pfizer, and Swiss pharmaceutical company Roche to purchase an oral COVID-19 treatment, and has already secured at least 20,000 doses.
The government has prepared a total of 36.2 billion won, including 16.8 billion won in this year’s supplementary budget and 19.4 billion won in next year’s budget to purchase oral therapeutics. The Korea Centers for Disease Control and Prevention (KCDC) announced that it will reflect the cost of purchasing treatments for 18,000 patients in this year’s supplementary budget and 20,000 patients in next year’s budget.