Not recruiting

Study of GS-5245 for Treating COVID-19 in Children and Adolescents

Verified siteInvestigationalNo placebo

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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 COVID-19 in children and adolescents. The treatment being tested is a medication called Obeldesivir, also known by its code name GS-5245. This medication is provided in the form of film-coated tablets, available in two strengths: 175 mg and 350 mg. The purpose of the study is to evaluate the safety and how the body processes Obeldesivir in young patients with COVID-19.

Participants in the study will take the medication orally, which means it is swallowed. The study will monitor the participants over a period of time to observe any side effects and how well the medication is tolerated. The study will also look at how the medication affects the symptoms of COVID-19 and whether it helps in reducing the virus in the body. The study will not use a placebo, meaning all participants will receive the actual medication.

The trial will include children and adolescents under 18 years of age who have been diagnosed with COVID-19. The study will track the participants' health and any changes in their condition, including the need for additional medical support, over a period of up to 35 days. The goal is to gather information that could help in understanding how Obeldesivir works in treating COVID-19 in younger patients.

The research process

The trial runs in 5 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 asked to provide written consent. If you are under 18, your legal guardian will provide consent, and you may be asked to give your agreement, known as assent, if possible.
Step 2
Initial screening
You will undergo an initial screening to confirm your eligibility. This includes confirming a positive test for SARS-CoV-2, the virus that causes COVID-19, within the last 5 days. You must also have shown symptoms of COVID-19 within the last 5 days.
Step 3
Medication administration
You will receive the medication Obeldesivir (also known as GS-5245) in the form of film-coated tablets. The dosage will depend on your age and weight, and the medication will be taken orally. The specific dosage and frequency will be explained to you by the study team.
Step 4
Monitoring and follow-up
Throughout the study, your health will be closely monitored. This includes regular check-ups to assess the safety and effectiveness of the medication. You will be observed for any side effects or changes in your condition.
Step 5
End of study participation
The study will conclude after a specified period, and you will have a final assessment. This will include evaluating your overall health and any changes in your COVID-19 symptoms.

Who can join the trial?

19 criteria

The participant or their legal guardian must be willing and able to provide written consent before any study procedures begin. If possible, participants should also agree to participate, according to local rules and the investigator's judgment.
The participant must be under 18 years old and meet specific weight and age criteria:
- Cohort 1: 6 to under 18 years old and weigh at least 40 kg.
- Cohort 2: 6 to under 18 years old and weigh between 20 kg and less than 40 kg.
- Cohort 3: 2 to under 18 years old and weigh between 12 kg and less than 20 kg.
- Cohort 4: 28 days to under 18 years old and weigh between 3 kg and less than 12 kg.
- Cohort 5: 14 to under 28 days old, born at or after 37 weeks of pregnancy, and weigh at least 2.5 kg.
- Cohort 6: 0 to under 14 days old, born at or after 37 weeks of pregnancy, and birth weight of at least 2.5 kg.
- Cohort 7: 0 to under 56 days old, born before 37 weeks of pregnancy, and birth weight of at least 1.5 kg.
- The participant must have a confirmed infection with the virus that causes COVID-19, verified by a test called polymerase chain reaction (PCR) or another similar test, within 5 days before the screening.
- The participant must have started showing signs or symptoms of COVID-19 within 5 days before the screening and have at least one symptom such as fever, cough, tiredness, shortness of breath, sore throat, headache, or muscle/joint pain at the time of screening.
- The participant must have at least one characteristic or underlying medical condition that increases the risk of severe illness from COVID-19, including:
  - Obesity: Body mass index (BMI) above the 95th percentile for their age and sex.
  - Diabetes
  - Chronic lung disease: Such as asthma or interstitial lung disease.
  - Cardiac disease: Such as congenital heart disease.
  - Immunosuppressive disease: Or receiving treatments that weaken the immune system, leading to moderate or severe immune system compromise.
  - Neurologic disorders: Such as epilepsy, convulsions, or cerebral palsy.
  - Genetic conditions: Such as trisomy or other chromosomal abnormalities.
  - Medical complexity: Including dependence on medical technology not related to COVID-19, such as a tracheostomy or positive pressure ventilation.
  - Other medical conditions that the investigator considers a risk factor.

Who cannot join the trial?

7 criteria

Participants who are not diagnosed with COVID-19 cannot join the study.
Participants who are not within the specified age range for the study cannot join. The study is for children.
Participants who are not able to follow the study procedures or take the study medication as required cannot join.
Participants who have certain medical conditions that might interfere with the study cannot join. These conditions will be assessed by the study doctor.
Participants who are taking other medications that might interfere with the study medication cannot join. The study doctor will review all medications.
Participants who have had a severe allergic reaction to similar medications in the past cannot join.
Participants who are part of another clinical trial cannot join this study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

ASST Fatebenefratelli Sacco
Verified
Milan, Italy
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital De La Santa Creu I Sant Pau
Verified
Barcelona, Spain

Trial locations

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Investigated drugs

Obeldesivir is a medication being studied for its potential to help children who have COVID-19. This medication is designed to work by stopping the virus from multiplying in the body, which may help reduce the severity of the illness. The study aims to understand how the medication moves through the body and how safe it is for children to use. Researchers are looking at how well children tolerate the medication and if it can effectively help them recover from COVID-19.

Gs-5245

What is already known about the treatment

Obeldesivir – Obeldesivir is administered orally and is currently being studied in clinical trials for its use in treating COVID-19, particularly in children. It is in the experimental phase, meaning it is not yet widely available or fully approved for general medical use. The main purpose of Obeldesivir is to help treat COVID-19 by interfering with the virus's ability to replicate, which can help reduce the severity of the disease. It belongs to a class of drugs known as antiviral medications, which are designed to combat viral infections.

Investigated diseases

COVID-19 – COVID-19 is an infectious disease caused by the 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 may also affect other organs, leading to complications such as kidney injury or heart problems. The progression of symptoms can vary widely, with some individuals experiencing mild symptoms and others developing severe illness. The virus spreads mainly through respiratory droplets from coughs, sneezes, or talking.