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Study on the Effectiveness and Safety of Bemnifosbuvir for High-Risk COVID-19 Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of COVID-19 in individuals who are at high risk of severe illness. The study will evaluate the effectiveness and safety of a medication called Bemnifosbuvir Hemisulfate, also known by its code name AT-527. Participants in the study will receive either Bemnifosbuvir Hemisulfate or a placebo, which is a substance with no active medication. The goal is to determine if Bemnifosbuvir Hemisulfate can reduce the chances of hospitalization or death in patients with COVID-19 who are receiving only supportive care, which means they are not receiving any other specific treatment for the virus.

The study will involve taking the medication in the form of tablets by mouth for a period of up to five days. Participants will be monitored for any changes in their health, including any potential side effects or complications related to COVID-19. The study will track the number of participants who are hospitalized or who die from any cause within 29 days of starting the treatment. Additionally, the study will look at other outcomes, such as the occurrence of COVID-19-related complications and the need for medical visits due to the virus.

By participating in this study, researchers hope to gather important information about the potential benefits of Bemnifosbuvir Hemisulfate in treating high-risk patients with COVID-19. This information could help in developing effective treatments for those who are most vulnerable to severe outcomes from the virus. The study is designed to ensure the safety and well-being of all participants while providing valuable insights into the treatment of COVID-19.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to receive either the study medication or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient. This process is called a double-blind study, meaning neither you nor the study team will know which one you are receiving.
Step 2
Medication administration
If you are assigned to the group receiving the study medication, you will take Bemnifosbuvir Hemisulfate orally in tablet form. The dosage and frequency will be provided by the study team. If you are in the placebo group, you will take a tablet that looks the same but does not contain the active ingredient.
Step 3
Monitoring and follow-up
Throughout the study, you will be monitored for any changes in your health. This includes regular check-ins with the study team to discuss any symptoms or side effects you may experience. You will also be asked to report any hospital visits or medical appointments related to COVID-19.
Step 4
End of study participation
The study will conclude after a specified period, and you will have a final visit with the study team. During this visit, your health will be assessed, and you will have the opportunity to discuss your experience in the study.

Who can join the trial?

12 criteria

Willing and able to provide informed consent, which means you understand the study and agree to participate.
Have a positive test for SARS-CoV-2 (the virus that causes COVID-19) within 5 days before joining the study. This can be a PCR test or a rapid antigen test.
Have mild or moderate COVID-19 symptoms that started within 5 days before joining the study. Symptoms can include fever, cough, sore throat, headache, muscle pain, nausea, vomiting, diarrhea, or loss of taste or smell. You should not have severe symptoms like difficulty breathing.
If you are a female who can have children, you must agree to use birth control or not have heterosexual intercourse during the study and for 30 days after the last dose of the study drug.
If you are a female who can have children, you must have a negative pregnancy test before starting the study drug.
Must be able to take oral tablet medications.
Must be willing and able to follow the study drug schedule and all other study requirements, as determined by the study doctor.
Must be considered high risk for severe COVID-19, which includes:
- Being 70 years or older.
- Being 55 years or older with one of the following conditions: obesity (body mass index of 30 or more), diabetes, heart disease, high blood pressure, or chronic lung disease.
- Being 50 to 54 years old with two of the following conditions: obesity, diabetes, heart disease, high blood pressure, or chronic lung disease.
- Being 18 years or older with one of the following: Down syndrome, sickle cell disease, dementia, Parkinson's disease, living in a care home, or having a weakened immune system due to certain conditions or treatments.
- Adolescents aged 12 to 17 years may be allowed to join after a specific point in the study is reached.

Who cannot join the trial?

6 criteria

Patients who are currently hospitalized cannot participate.
Patients who have received any other treatment for COVID-19 besides supportive care are not eligible.
Patients with a history of severe allergic reactions to any of the study medications cannot join.
Pregnant or breastfeeding women are excluded from the study.
Patients with any other serious medical condition that might interfere with the study cannot participate.
Patients who are unable to follow the study procedures or instructions are not eligible.

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Verified sites

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Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Ludwig Maximilian University Of Munich
Responsive
Munich, Germany
Region Vaesterbotten
Responsive
Umea, Sweden

Trial locations

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Investigated drugs

Bemnifosbuvir is a medication being studied for its potential to help people with COVID-19 who are at high risk of severe illness. It is designed to reduce the chances of hospitalization or death from any cause in patients who are only receiving supportive care. This means that the medication is being tested to see if it can help prevent serious outcomes in people who have COVID-19 but are not receiving other specific treatments for the virus. The study aims to find out if this medication can make a significant difference in the health of these patients.

What is already known about the treatment

Bemnifosbuvir – Bemnifosbuvir is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating COVID-19. It is not yet widely used in medicine, as it is still under investigation to determine its safety and efficacy. The main therapeutic indication for Bemnifosbuvir is to reduce the risk of hospitalization or death in high-risk outpatients with COVID-19. At the molecular level, it works by inhibiting the replication of the virus that causes COVID-19, thereby helping to control the infection. It is classified as an antiviral medication.

Investigated diseases

COVID-19 – COVID-19 is an infectious disease caused by the novel coronavirus SARS-CoV-2. It primarily affects the respiratory system, leading to symptoms such as fever, cough, and difficulty breathing. The disease can progress to more severe respiratory issues, including pneumonia and acute respiratory distress syndrome. In some cases, it can also affect other organs, leading to complications like sepsis, coagulopathy, and cardiac issues. The progression of the disease varies widely among individuals, with some experiencing mild symptoms and others developing severe illness. COVID-19 is primarily spread through respiratory droplets from coughs, sneezes, or talking.