Study of ibuzatrelvir tablets in non-hospitalized adults and adolescents with COVID-19 who are at high risk of developing severe illness

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What is this study about?

This study focuses on treating people with COVID-19 who are not in the hospital but have a high risk of developing severe illness. The study will test a new medication called ibuzatrelvir, which comes as a film-coated tablet that is taken by mouth. Some participants will receive ibuzatrelvir while others will receive a placebo.

The purpose of this research is to determine how well ibuzatrelvir works compared to placebo in treating people with COVID-19 who are at high risk of their condition becoming worse. The study will include both adults and adolescents who weigh at least 40 kilograms (about 88 pounds) and who cannot or choose not to take other available COVID-19 treatments.

During the study, participants will take either ibuzatrelvir tablets or placebo tablets. The researchers will monitor participants for 28 days to see if they need emergency care, require oxygen support, need additional treatments, are hospitalized, or experience other health issues. They will also track how quickly symptoms improve and check for any lasting effects of COVID-19 for up to 24 weeks after treatment begins.

1 Initial screening

Your eligibility will be verified based on age (12 years and older, with weight at least 40 kg for ages 12-17) and presence of risk factors for severe COVID-19

A nasal test called RAT (Rapid Antigen Test) will confirm your COVID-19 infection within 24 hours before starting the study

It will be confirmed that you are unable or unwilling to take nirmatrelvir/ritonavir treatment

2 Treatment assignment

You will be randomly assigned to receive either ibuzatrelvir tablets or placebo tablets (tablets without active medication)

Neither you nor your doctor will know which treatment you are receiving

3 Treatment period

You will take the assigned tablets by mouth

Your symptoms will be monitored for 28 days

Any emergency department visits, need for oxygen, additional treatments, hospitalizations, or other medical events will be recorded

4 Follow-up period

You will be monitored for up to 24 weeks after starting treatment

The medical team will assess for any long-term COVID symptoms

Your health status will be evaluated throughout this period

5 Study completion

Final health assessment will be performed at week 24

Your participation in the study will end after completing all required evaluations

Who Can Join the Study?

  • Must be at least 12 years old and weigh at least 40 kg, or be 18 years or older of any weight
  • Must have risk factors that could make COVID-19 more severe, based on age (for example, older adults are at higher risk)
  • Must have a positive COVID-19 test from a rapid antigen test (RAT) using a nasal swab taken within 24 hours before starting the study
  • Must be unable or unwilling to take nirmatrelvir/ritonavir (which is another COVID-19 treatment medication)
  • Both men and women can participate in the study

Who Cannot Join the Study?

  • Patients who are hospitalized due to COVID-19
  • Patients who require supplemental oxygen therapy (extra oxygen support)
  • Individuals who have previously received COVID-19 antiviral treatments for their current infection
  • Patients with severe liver problems or abnormal liver function tests
  • People with known allergies to ibuzatrelvir or its components
  • Pregnant or breastfeeding women
  • Patients taking medications that may interact with ibuzatrelvir
  • People who have participated in another clinical trial within the past 30 days
  • Patients with uncontrolled chronic conditions (such as diabetes or high blood pressure that is not well-managed)
  • Individuals who have received monoclonal antibody therapy (specialized protein treatments) for COVID-19
  • People who cannot take oral medications
  • Patients with severe kidney disease requiring dialysis

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Artromac N.O. Kosice Slovakia
Mizexhm Czeizx Hiqf Ehqs Sofia Bulgaria
Hjrbrpzl Vzok dxaubyqp Barcelona Spain
Rxfaot Slsopxosq Holbæk Denmark
Hieuswce Uwotbhvtyzejg dd A Caybtu A Coruna Galicia Spain
Crnskqm Uqtioyeumierbclrqbpr Bcvawb Ksu Berlin Germany
Avvqprk Utemhtfcfl Hbopiczp Aalborg Denmark
Mxxhils Cqlpcg &ezofuv Udqmialdrr Od Fuajftwa Freiburg Im Breisgau Germany
Kfhiupwp dfe Uboktitcamxk Meubjewx Acw Munich Germany
Rdpnle Mckqxysdori Aarhus Denmark
Hodgelcf Vlqumj Xobal Ieyioerpavavd Benalmadena Spain
Upmuxptutn Mnfvphv Cdrlre Hwwccomrvsqbevdhf Hamburg Germany
Fvwqcgrdf Puzy Lx Ihvkbjlhrghyy Bglkjnxuk Dmu Hggbgqcr Uxjccpaxitcvs Lr Pjy Madrid Spain
Ubcdhuscxt Mnvfymtsitpw Hkkwdnjg Frn Azveix Tklatncto Swivv Gjospz Epe Plovdiv Bulgaria
Nqqikvzqwt Bcdaug Gyq Berlin Germany
Pjvmethf asdiboevmi Hynovtay seyklr Spisska Nova Ves Slovakia
Prfsxs Eujkxgqqnm Cologne Germany
Phwlo samajb Presov Slovakia
Rvcarl Ayrqzqgh Mbzg Ai Pernik Bulgaria
Mdtwebr Cubkqb Dexcnikp 2yfz Ekrs Yambol Bulgaria
Vovit syywzk Trnava Slovakia
Shicafe Sa sxeoxa Nove Mesto Nad Vahom Slovakia
Apxerlravy Fts Itrkmynfxh Pdnqixs Mykowol Aug Dob Poelnin Pqzilgx Plvd En Sofia Bulgaria
Svowlnomwkisa Hiissznbndrab Munich Germany
Oelehinu Hwhkhzfe sgwwba Ceske Budejovice Czechia
Hpajmhnr Ufmoyngadtdmk Vuursp Dr Vstoc Sevilla Spain
Apltb Alken Belgium
Mbkoxhln Mffixuu Aqbbdqa Pleven Bulgaria
Hletwrrv Axzten Czbleiuvm Vigo Spain
Hmbjexvt Hxgwsehi Hillerød Denmark
Uixrybyjqtmarsvfetllw Asesntex Augsburg Germany
Hlrglflv Uzuiaveecqimg Ioxipya Lmlori Madrid Spain
zxdq Zmsdzqq fhdp Iagndmceqfonb Bcibxo Pfxgrynubz Byth Gkmw Berlin Germany
Mntazlt Caolzm Poptbjjhwy Erdy Haskovo Bulgaria
Pyusgumjjk Namur Belgium
Aysixuuir Mdovpbu Cyjwwd Oyf Dupnitsa Bulgaria
Mulj Mfjgaec sdkdby Moldava Nad Bodvou Slovakia
Dmvtjtzkqm Cekucbrwramg Cxsyhx 1 Lhr Enic Lom Bulgaria
Hrtfugfk Utbtrbbonzsbv Hfqrcoef Tubzm y Pskuww Ieslflya Cuwhfq dacbnmcpootlhwlba (mlrb Badalona Spain
Muyfjhk Cuqhjd 1 Sthkhnfl Errt Sevlievo Bulgaria
Sqaysyf Rdrdgd &idan Dqfup Gjus Obertshausen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
05.07.2025
Bulgaria Bulgaria
Recruiting
05.07.2025
Czechia Czechia
Recruiting
05.07.2025
Denmark Denmark
Recruiting
05.07.2025
Finland Finland
Recruiting
05.07.2025
Germany Germany
Recruiting
05.07.2025
Slovakia Slovakia
Recruiting
05.07.2025
Spain Spain
Recruiting
05.07.2025

Trial locations

Investigated Drugs:

Ibuzatrelvir is an oral antiviral medication being studied for treating COVID-19. It is designed to help people who have COVID-19 but are not hospitalized and are at high risk of their illness becoming more severe. The medication works by targeting the virus that causes COVID-19, aiming to reduce the severity of the infection and prevent the disease from progressing to a more serious state.

Investigated Diseases:

COVID-19 – A respiratory disease caused by the SARS-CoV-2 virus that primarily affects the lungs and respiratory system. The infection typically begins with symptoms such as fever, cough, fatigue, and loss of taste or smell. In some cases, the disease can progress from mild to more severe symptoms, particularly in individuals with certain risk factors. The condition can affect multiple body systems and may lead to varying degrees of respiratory difficulties. Some people may develop longer-lasting symptoms known as Long COVID, where effects persist beyond the initial infection period.

Long COVID – A condition where symptoms persist or develop after the initial COVID-19 infection has resolved. Symptoms can include ongoing fatigue, shortness of breath, cognitive difficulties (often called “brain fog”), muscle weakness, and various other physical and neurological effects. The condition can affect daily activities and may fluctuate in intensity over time. Long COVID can occur even in people who had mild initial COVID-19 symptoms.

Trial ID:
2024-517727-39-00
Protocol code:
C5091017
NCT ID:
NCT06679140
Trial Phase:
Therapeutic confirmatory (Phase III)

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