Be Part of Research - Trial Details

Recruiting

Open to: All Genders

Age: 18 Years - 100 Years

Medical Conditions

Acute upper respiratory infections
Influenza and pneumonia

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Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) is a research study being conducted in many countries around the world,and funded by the National Institutes of Health,USA. STRIVE will evaluate the safety and effectiveness of new and already approved treatments and different combinations of treatments,to treat adults hospitalised with acute respiratory infections,like COVID-19 or influenza. Within the research study,several different research trials will be conducted at the same time.

The first trial in STRIVE is a randomised (this means people are allocated into one of 2 different groups by a computer programme) trial in adults hospitalised with COVID-19. STRIVE trial-1 will assess whether a 5-day course of tablets of the antiviral drug ensitrelvir (S-217622) or a matching placebo (a dummy pill that looks exactly the same as the real pill) in addition to standard-of-care treatments (which can include other antivirals like remdesivir; and medication like steroids to dampen down the harmful immune response),is safe and effective. Consenting participants will be randomised with an equal chance to S-217622 or placebo and receive 5 days of treatment,on the first day there are 3 tablets by mouth,and then 1 tablet every day for the next 4 days. The trial is conducted double-blind,this means that the participants and the Doctors and nurses don’t know whether the participant received active medication or the placebo. All participants will receive the full 5-day course,so this means if they are discharged from hospital before course of tablets is completed,they will take the remaining tablets at home. The course of tablets come in a blister pack,so it’s very easy to take the tablets on the correct days. In terms of what’s required,the participant will be seen on the day of the first tablets (Day 0),and then on days 1-7,14,28,42 and 60. These visits are quite short,and the researchers will assess how someone is doing i.e. their health status,check for any side-effects of the medication,any changes in other medication and take bloods for future COVID-19 research (on visit Days 3 and 5) and a nose swab on Day 5. The reason a nose swab is taken on Day 5 is we will measure the levels of the SARS-CoV-2 virus (this is the virus that caused COVID-19) to see what effect the antiviral is having if they are on the active medication,compared to what the levels are if they are on the placebo drug. There is an option to give bloods on Day 14,but if participants don’t want to do this,that’s fine. For the study visits where no blood samples or nose swab tests are needed,the visits can be done on the phone.

You can take part if:

You may not be able to take part if:

STRIVE Platform Exclusion Criteria: 1. The patient is expected to be discharged from the hospital within the next 24 hours. 2. Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization. 3. Moribund condition,defined as prior cardiac arrest during this hospitalization and life expectancy less than 48 hours of randomization. 4. Patient undergoing comfort care measures only such that treatment focuses on end-of-life symptom management over prolongation of life. 5. Expected inability or unwillingness to participate in study procedures. 6. In the opinion of the investigator,participation in a trial is not in the best interest of the patient. Additional Trial 1 Exclusion Criteria: 1. Allergy to investigational agent or vehicle 2. Use of a concomitant medication that is contraindicated due to a drug-drug interaction with S-217622 (see section 6.3 and protocol instruction materials) 3. Moderate to severe hepatic impairment (i.e.,Child-Pugh class B or C) or acute liver failure. 4. Known estimated glomerular filtration rate (eGRF) <30 mL/min/1.73m2 5. Continuous renal replacement therapy or chronic dialysis 6. Current pregnancy 7. Current breastfeeding and unwillingness to defer breastfeeding for 30 days after the last dose of investigational agent. 8. Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception through 30 days from the last dose of the investigational agent. 9. Men who are unwilling to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 30 days from the last dose of the investigational agent.

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for Trial ID: CPMS 61089

Last updated 25 April 2025

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STRIVE

Recruiting

Open to: All Genders

Age: 18 Years - 100 Years

Medical Conditions

Interventional

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STRIVE

Recruiting

Open to: All Genders

Age: 18 Years - 100 Years

Medical Conditions

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Interventional

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This page is to help you find out about a research study and if you may be able to take part