A Phase 3, Multi-Center, Randomized, Double-Blind, 24-Week Study of the Clinical and Antiviral Effect of S-217622 Compared with Placebo in Non-Hospitalized Participants with COVID-19 (ACTIV 2D STUDY)

December 26, 2024| Completed Project | Reading time: 8 min

Introduction

Kintampo Health Research Centre (KHRC) has ended this ACTIV 2D study, that explored a new treatment for COVID-19, potentially reducing hospitalizations and saving lives. The study, funded by the National Institute of Allergy and Infectious Diseases (NIH), Division of AIDS (DAIDS), tested the antiviral drug S-217622 and was conducted across multiple research centres.

Investigators

Dr. Seyram Kaali, Dr. Kwaku Poku Asante, Dr. Samuel Harrison, Dr. Prince Darko Agyapong, Dr. Cynthia Yaa Bema, Dr. Felicia Serwah, Dr. Afia Korkor Opare Yeboah, Mr. Elvis Ato Wilson, Mr. Zakariah Buwah, Mr. Francis Mensah Kornu.

Background

COVID-19, caused by the SARS-CoV-2 virus, was first identified in Wuhan, China, in December 2019 and quickly spread worldwide, becoming a pandemic. Vaccination has been an important tool to reduce infection and complications of infections, and vaccination campaigns are underway globally with variable reach, course completion, and uptake.

Unfortunately, new variants of SARS-CoV-2 have appeared that spread more easily and may weaken the effectiveness of vaccines, especially as time passes. During the Omicron surge, studies showed that vaccine protection against symptoms and, in some cases, hospitalization declined after 3 to 4 months. This means that even people who are fully vaccinated or have received booster shots can still get COVID-19. Some may even experience severe illness, especially if their vaccine protection has weakened over time or if they have higher risk factors like a weakened immune system or older age.

Even though some treatments, like emergency-approved COVID-19 antibodies and repurposed drugs, are being used in the U.S. and other countries, effective medications for adults with COVID-19 who aren’t hospitalized are still hard to find or access. As a result, deaths from COVID-19 are still happening around the world.

Objectives
The main objective of the study was to evaluate the efficacy of S-217622 vs. placebo. The study also seeks to determine whether S-217622 reduces COVID-19- related hospitalization (adjudicated) and all deaths regardless of occurrence outside of hospital or during hospitalization (not adjudicated) through Day 29.

Study Methodology
This study was conducted at multiple locations and involved participants with mild or moderate COVID-19 who were not at high risk of severe illness. Participants were randomly assigned to three groups:

A low-dose group receiving S-217622 (375 mg on the first day, then 125 mg daily for 4 days).

A high-dose group receiving S-217622 (750 mg on the first day, then 250 mg daily for 4 days).

A placebo group receiving no active treatment. All three groups received 5 days of total treatment.

The study had two main phases:

Phase 2a tested if repeated doses of S-217622 could reduce the virus in the body and helped decide the right dose to be implemented in Phase 3 studies.

Phase 2b/3 checked how well the treatment worked in participants with mild, moderate, or no symptoms and no risk factors for severe disease.

The study also looked at how long it took for participants to stop spreading the virus, for symptoms to improve or disappear, and whether those without symptoms developed any. Around 2,600 people were expected to take part in the study.

Expected Outcomes
The ACTIV-2d study is expected to generate evidence towards the discovery of a safe and effective medicine that will relieve participants of symptoms of COVID-19 as well as prevent hospitalization of covid-19 positive participants.

Funder
National Institute of Allergy and Infectious Diseases (NIH), Division of AIDS (DAIDS)

Conclusion
This study has laid the foundation for further research into S-217622, which could become a n effective treatment for COVID-19. The results hold promise for reducing the burden of the disease, especially for those unable to access hospital care. As data from this study is analyzed, it may lead to more effective therapies being made widely available to combat COVID-19 globally.

Study Duration: One (1) Year
Start Date: September
End Date: September 2024