Can this oral drug protect you from getting COVID after exposure at home?
Are you living with someone who tested positive for COVID-19 within the last five days?
If yes, and you haven’t been vaccinated, do not have any symptoms, and have never had COVID-19, MSD and Ridgeback Biotherapeutics need you.
MSD and Ridgeback Biotherapeutics recently announced the initiation of the pivotal Phase 3 of the MOVe-AHEAD Study, evaluating molnupiravir for post-exposure prophylaxis of COVID-19 infection.
The global study is now enrolling individuals who are at least 18 years old 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, in a press statement. “If successful, molnupiravir could provide an important additional option towards reducing the burden of COVID-19 on our communities.”
MOVe-AHEAD is a Phase 3 multi-center, 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.
Let the trial begin
In the Philippines, Asian Hospital and Medical Center (AHMC) and Quirino Memorial Medical Center (MMMC) are the clinical trial sites for the study, which began in November 2021. Recruitment of enrollees will be held until February 2022.
The trial will enroll approximately 1,332 participants who will be randomized to receive either molnupiravir or placebo in preventing the spread of SARS-CoV-2 within households.
“The MOVe-AHEAD study would be the post-exposure prophylaxis study for molnupiravir,” said Dr. Joel Santiaguel, principal investigator, QMMC.
Prior to the MOVe-AHEAD Study, Merck-Ridgeback conducted the MOVe-Out Study in adults with mild-to-moderate COVID-19.
“For MOVe-AHEAD, we’re looking for those who were exposed to the index case (COVID-19 patients). And we’re doing this clinical trial to demonstrate whether this drug is an effective drug for post-exposure prophylaxis,” explained Dr. Benjamin Co, principal investigator, AHMC.
According to Dr. Co, post-exposure prophylaxis will make a big difference “in the way we’ll handle the pandemic eventually.”
“Imagine, when you get exposed to somebody who has COVID-19, just take this pill and you won’t get infected,” he added.
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.
Participants are not eligible for 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.
The signs to watch out for are: fever or chills, cough, sore throat, shortness of breath, fatigue, nasal congestion, runny nose, headache, muscle or body ache, feeling sick to your stomach or throwing up, diarrhea, and loss of taste or smell.
The primary endpoints of the trial include percentage of participants with COVID-10 through Day 14, percentage of participants with an adverse event and percentage of participants who discontinued study intervention due to an adverse event.
So, what will happen if you take part in the study?
“If you qualify and agree to take part, you will be given molnupiravir or placebo to take by mouth every 12 hours for five days,” explained Dr. Co.
There will also be trial visits, which may take place at a hospital, home, or virtually.
“The total time you will take part in the trial is about one month,” added Dr. Co.
Taking part in this trial is voluntary and you may stop for any reason at any time. If you decide to stop taking part, or stop taking the trial treatment, your attending physician will ask you to have a final visit for medical tests and exams.
If you quality and agree to take part, you may help researchers learn more about treatment options for COVID-19.
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Individuals who wish to participate or healthcare professionals who would like to refer patients may call or text AHMC at 0968-5583091 or 0927-0076602; or QMMC at 0917-8413314.
To learn more, visit msdcovidresearch.com.
