The University of Nebraska Medical Center and Nebraska Medicine have launched a new clinical research trial for adults who live with someone who has tested positive for COVID-19. The trial will evaluate if Molnupiravir, an oral antiviral, can prevent COVID-19. The trial also will assess the safety of the drug.
Clinical trials are research studies performed with human volunteers that aim to evaluate if investigational treatments and vaccines are safe and effective for people.
To date, there have been more than 5 million deaths around the world due to COVID-19, according to the World Health Organization.
Molnupiravir (also known as MK-4482 and EIDD-2801) is an investigational medicine that can be swallowed and, in preclinical studies, demonstrated an ability to prevent the growth of SARS-CoV-2, the virus that causes COVID-19. The trial is sponsored by Merck Sharp & Dohme Corp.
The primary objective of the randomized, double-blind, placebo-controlled phase 2 and 3 study, called MOVe-AHEAD, is to evaluate if Molnupiravir, compared to placebo, is safe and effective at preventing hospitalization or death in adults residing with a person who has COVID-19.
Study participants will be randomly assigned to receive either the study drug or placebo every 12 hours for five days. There will be follow-up visits that take place on days five, 14, 21 and 29. Some visits may be completed by telephone or video call.
Diana Florescu, MD, professor in the UNMC Department of Internal Medicine and an infectious diseases specialist at Nebraska Medicine, is leading the UNMC clinical trial.
"For many years, antivirals such as this drug, have been effective in preventing illness after exposure to a variety of pathogens and to reduce the risk of spreading the infection to close contacts," Dr. Florescu said. "We hope that Molnupiravir will decrease SARS-CoV-2 transmission between family members and prevent illness after exposure to SARS-CoV-2, including variants with spike gene mutations for which current vaccines may not provide protection."
About 1,300 participants will be recruited for the international study, which will take about one month from the time the participant provides documented informed consent, through the final contact.
There is no cost for the trial drug or the trial-related medical tests and exams.
You may qualify if you:
- Are at least 19 years old
- Have not received a COVID-19 vaccine
- Have never had COVID-19
- Live with someone who recently tested positive for COVID-19
If you are interested in learning more about the study, email FlorescuResearchTeam@unmc.edu or call 402-559-7685 and reference IRB# 465-21-CB study.
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