MSD and Ridgeback Biotherapeutics announce initiation of Pivotal Phase 3 MOVe-AHEAD study evaluating Molnupiravir for Post-Exposure Prophylaxis of COVID-19 infection
MSD, known as Merck
& Co., Inc., Kenilworth N.J., USA
(NYSE:MRK) in the U.S. and Canada and Ridgeback Biotherapeutics recently announced the initiation of the Phase 3 MOVe-AHEAD clinical trial to evaluate molnupiravir, an investigational oral antiviral therapeutic, for the prevention of COVID-19 infection.
The global study is enrolling individuals who are at least 18 years of age and reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms
.
“As the pandemic continues to evolve and surges are being reported in many places around the world, it is important that we investigate new ways to protect individuals exposed to the virus from becoming infected with symptomatic disease,” said Dr. Nick Kartsonis, senior vice president, vaccines and infectious diseases, clinical research, Merck Research Laboratories. “If successful, molnupiravir could provide an important additional option towards reducing the burden of COVID-19 on our communities.”
MOVe-AHEAD (MK-4482-013) is a Phase 3 multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of orally administered molnupiravir compared to placebo in preventing the spread of SARS-CoV-2, the virus that causes COVID-19, within households. The trial will enroll approximately
1,332 participants
who will be randomized to receive either molnupiravir (800 mg) or placebo orally every 12 hours for five days. The study will enroll participants who are at least 18 years of age and currently residing in the same household with someone who received a positive test for SARS-CoV-2, has at least one sign or symptom of COVID-19 and has not had those signs and symptoms for more than five days. Participants are not eligible for the trial if they have received the first dose of a COVID-19 vaccine more than seven days prior to enrollment, have previously had COVID- 19 or are showing any signs or symptoms of COVID-19.
In the Philippines, Asian Hospital and Medical Center (AHMC) and Quirino Memorial Medical Center (QMMC) are the clinical trial sites for the study, set to begin this November 2021.
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Individuals who wish to participate or healthcare professionals who would like to refer patients may call or text the Asian Hospital and Medical Center at 0968 558 3091 or 0927 007 6602; or the Quirino Memorial Medical Center at
0917-841-3314.
The primary endpoints of the trial include percentage of participants with COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14, percentage of participants with an adverse event and percentage of participants who discontinued study intervention due to an adverse event.
For more information, please visit
http://merckcovidresearch.com
.
ADVT
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