Study Overview
The study will test the safety and effectiveness of molnupiravir, an antiviral study drug, which may reduce symptoms and recovery time for people who tested
positive for COVID-19 in the last 7 days.
This clinical study will heIp researchers Iearn whether the study drug:
Is Safe
Decreases symptoms and how well it controls the COVID-19 infection
Is handled well by the body
What requirements are in place to help protect clinical trial participants?
There are rules in place to help protect the rights, safety, and well-being of people who volunteer tor research studies. These rules are put in place to make sure studies follow strict scientific and ethical guidelines.
Before a clinical research study can begin a review board must review the study. This group is called an IRB
or institutional review board. An IRB is made up of doctors, scientists and members of the community
Who Can Join
To participate in the molnupiravir sstudy for non-hospitalized patients,
participants must be 18 years or older and:
Test positive for COVID-19
in the last 7 days
Currently have at least
one symptom of COVID-19
Not hospitalized or expecting
to be in the near future
What To Expect
This study will have participants involved for
about 7 months over 3 trial phases
Screening Phase
(Up to 48 hours)
1
To ensure participants qualify we may do:
-
A Physical Exam
-
An intake of his/her medical history
-
Blood Test
Treatment Phase
(29 Days)
2
If they qualify and agree to take part, study patients will be put into a group by chance to get either molnupiravir
(the antiviral sludy drug) or placebo. A placebo looks like the study drug, but does not contain any active medicine.
Participants will:
-
Take study treatment twice a day for 5 days
-
Have blood tests
-
Have swab tests of nose and/or throat
-
Have Physical Exams
-
Keep diaries of taking his/her study drug and symptoms
Follow-up Phase
(After about 6 months)
3
We'll schedule a phone call about 6 to 8 months after your last treatment to:
-
Provide the study doctor or a member of the study staff with updates on how participants are feeling
Why participate in this study
A clinical trial is a research study that tries to answer questions about how medicines work in the people who take them. Researchers run studies to test whether an investigational medication is safe and effective. These studies may help doctors find new ways to help, prevent, detect, or treat health problems. Information learned from this clinical research study may help other people in the future.
Additional care may also be provided for COVID-19 for those participating. This may include:
Medical Care
Treatment for COVID-19 and related symptoms
Is this mandatory?
Will it cost anything?
Taking part in this study is voluntary and the participant may stop at any time for any reason.
In addition, there is no cost for the study drug or study-related care, tests and exams.