PROTOCOL
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection with Symptoms) in Adults Residing With a Person With COVID-19
SUMMARY
The World Health Organization (WHO) declared COVID-19 a global pandemic on 11 March 2020. As of 2 August 2022, WHO states that there were:
- 575, 887, 042 confirmed COVID-19 cases worldwide with 6, 398, 412 deaths
- 337, 622 confirmed COVID-19 cases in Kenya with 5, 672 deaths
Kenya Medical Research Institute (KEMRI) in partnership with MSD, a drug manufacturing company is conducting a new COVID-19 prevention study- the MOVe AHEAD study.
MOVe AHEAD study is a clinical research trial testing a new medication that may prevent COVID-19 among people who live with someone who has COVID-19. For people who are not/ do not want to be vaccinated, this new drug may provide an alternative option.
The study has been approved by Pharmacy and Poison Board (PPB) and the KEMRI Scientific Ethics Review Unit (KEMRI- SERU). The trial medication comes in a capsule form, 4 capsules should be taken 2 times a day for 5 days. The trial aims to evaluate whether the new drug (molnupiravir) prevents the spread of COVID-19 in households.
You may be able to join this trial if you are at least 18 years old and above and live with an adult or a child who has symptoms and tested positive for COVID-19 in the past 5 days. Other adults within your household may also be able to join this trial. You are requested to share with them and consider asking them if they also want to join the trial. There may be reasons why you cannot be in this clinical trial of which the study doctor or staff will discuss with you. Being part of this clinical trial is voluntary.
If you join, you will be in the trial for up to one month. You will have 5 visits to the study site and 1 virtual visit (phone call). The study site is at the KEMRI CIS building in Lumumba Subcounty Hospital, Kisumu. Anyone living within Kisumu county who meets eligibility can join the study. If you would like to learn more about this trial, please contact the study staff by visiting KEMRI CIS building in Lumumba Subcounty Hospital, Kisumu or by dialling 0780 139 961.
SPONSORS AND PARTNERS
Study Design
| Study Phase | Phase 3 |
| Primary purpose | Prevention |
| Indication | Prophylaxis of COVID-19 in adults |
| Population | Participants ≥18 years of age |
| Study type: | Interventional study |
| Study intervention/ treatment: | Molnupiravir (MK4482) or placebo |
| Estimated enrolment: | 1336 (Up to 150 at Kisumu site) |
| Type of control | Placebo-controlled |
| Study Blinding | Double-blind with in-house blinding |
| Blinding Roles | Participants or Subjects Investigator Sponsor |
| Official Title: | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection with Symptoms) in Adults Residing with a Person with COVID-19 |
| Short Title: | MOVe AHEAD study |
| Study start date: | July 2022 |
| Estimated study completion date: | November 2022 |
RCTP-cmr 