Researchers at the University of Nebraska Medical Center and Nebraska Medicine are recruiting patients for a clinical trial testing whether an oral drug can prevent COVID-19 in adults who live with someone who has tested positive for COVID.
The researchers earlier participated in a trial to determine whether the drug, an antiviral medication called molnupiravir, could reduce COVID symptoms, recovery time, hospitalizations and even deaths in people who took it shortly after they developed symptoms.
Drugmaker Merck reported in September that the pill cut rates of hospitalization and death by 50% in people with early symptoms. The Food and Drug Administration is scheduled to review the results and consider Merck’s request for emergency use of the drug later this month.
Dr. Diana Florescu, who is leading the trial at UNMC, said researchers now want to know whether the drug is safe and effective at preventing hospitalization and death in those living with someone ill with the virus.
Family members of infected people are at highest risk because they have prolonged contact, limited ability to isolate within the household and typically don’t wear masks in the home.
“The exposure is much higher for family members,” said Florescu, a professor in UNMC’s internal medicine department and an infectious diseases physician with Nebraska Medicine.
Researchers worldwide have been working since the pandemic began to develop an oral medication that infected people could take soon after symptoms emerge to head off the worst of the illness. Currently, available COVID-19 treatments are delivered intravenously or by injection.
The United Kingdom authorized Merck’s drug earlier this month. The firm also has agreed to let other companies make the pill available in poorer countries.
On Tuesday, drugmaker Pfizer announced a similar arrangement for its COVID-19 pill. The company said it reduced the risk of hospitalization and death by nearly 90% in people with mild to moderate coronavirus infections, the Associated Press reported.
Florescu said the new trial is intended to test the Merck drug in patients soon after exposure, without waiting for symptoms to begin.
“The earlier you start, the more likelihood the medication would work, because there’s a low viral load,” she said.
The drug is not, however, a substitute for COVID-19 vaccines, Florescu said. The vaccines provide immunity for months, while the drug would provide protection only during its five-day course.
If the drug proves effective, it could help ease the strain on hospitals. “If we have a drug that is available for post-exposure prophylaxis and it decreases the rate of hospitalizations,” she said, “it would have a significant impact on health care.”
About 1,300 participants will be recruited for the international study, which will take about a month from the time participants provide consent through the final contact.
Volunteers must be at least 19 years old and live with someone who recently tested positive for COVID-19. They cannot have received a COVID vaccine or had the coronavirus. Eligible participants will be assigned to get either the drug or a placebo. Those interested in learning more about the study can email FlorescuResearchTeam@unmc.edu or call 402-559-7685. Reference the IRB# 465-21-CB study.
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