Short Trial Name: Clinical trial of Molnupiravir in non-hospitalised adults with COVID-19 who are at high risk of getting worse (MOVe-NOW Clinical Trial)

Full Trial Name: A Phase 3, Randomised, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalised Adults with COVID-19 at High Risk for Disease Progression         

Protocol Number: MK-4482-023

IRAS Number: 1010819

We are inviting you to take part in a research trial

  • We would like to invite you to take part in a clinical trial with a drug molnupiravir (MK-4482). This trial is for people who have COVID-19.
  • This information sheet summarises why the trial is being done and what is involved.
  • Taking part in this trial is voluntary.   It is up to you to decide whether or not to take part. 
  • You do not need to take part in this trial to be treated for your COVID-19.
  • You can stop taking part in the trial at any time without giving a reason, by telling your trial doctor your decision.

What is the trial?

This trial is testing molnupiravir in adults who have COVID-19 and have not been hospitalised.

Molnupiravir has been approved in the UK to treat adults with COVID-19 who are at high risk for severe illness.

The trial drug may be available by prescription for COVID-19. This trial will compare molnupiravir to placebo.

A placebo looks like a trial drug, but it has no active ingredients.

This trial is being done to:

  • Test the safety of molnupiravir compared to placebo.
  • See how well molnupiravir works to prevent death or the need for medical care or hospitalisation after infection with COVID-19, compared to placebo.
  • See how well molnupiravir works to reduce COVID-19 symptoms, compared to placebo.
  • Measure how well molnupiravir works to lower levels of the virus that causes COVID-19, compared to placebo.
  • See how well molnupiravir works to prevent long COVID-19, compared to placebo.

If you take part in this trial, you will visit the trial doctor at the trial site as explained in the study 

diagram below. Most visits will last about 2 to 3 hours.

How long you will be in the trial depends on whether you have COVID-19 when you join the trial or not. If you start taking the trial drug/placebo, you will be in the trial for about 6 months.

The following diagram shows the trial design:

picture1

This trial is being sponsored by the pharmaceutical company Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, USA (“MSD”). Whiteladies Health Centre will be paid by MSD.

Who can be in this trial?

You can be in this trial if you have COVID-19. There may be reasons why you cannot be in this trial.  The trial doctor or staff will discuss these reasons with you.   About 3,082 participants will take part in the in trial 25 countries. 

What drug will I get?

The drug you get will depend on which group you are placed in. This trial has 2 groups:

  • Group 1 will get molnupiravir.
  • Group 2 will get the placebo.

A computer will decide which group you are put in. You have an equal chance of either getting molnupiravir or placebo.

You, your trial doctor, and the trial staff won’t know what drug you are getting. In case of a health emergency, they can find out.

Molnupiravir is a tablet. Two tablets are taken by mouth 2 times daily (every 12 hours) for 5 days.

If you take the placebo, the tablet will look close to or exactly like molnupiravir, but it does not contain any active ingredients.

Expenses and payments

All trial drugs and trial-related tests will be provided at no cost to you.  You will and your companion or carer, if applicable will be reimbursed for your transportation, hotel (if an overnight stay is required), parking, meals and refreshments, or other reasonable expenses related to your participation in this trial.

In addition to your expenses, you will also be offered monetary payments for the trial visits and completing questionnaires. The trial staff will provide more information on this.

How will my privacy be protected?

The trial team and Sponsor have strict privacy and confidentiality policies in place to protect your information. The Sponsor will ensure adequate safeguards are in place to protect your data and abide by UK data privacy laws. Information about you will be collected and shared as described in the main participant information sheet, which will be given to you if you would like more information about the trial.

What happens next?

If you would like further details on this trial, please contact your trial doctor whose contact details are in the “How to contact us” section at the end of this document. If you wish to consider taking part in the trial, you must read and sign the main participant information sheet and consent form.

How to contact us

If you have any questions about this trial, please contact your trial doctor at:

Dr Stephen Granier

Whiteladies Health Centre 

Whatley Road 

Clifton

Bristol 

BS8 2PU

0117 973 1201  

Steve.granier@nhs.net