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
Medical Center Hera EOOD Sofia Bulgaria
Hospital Universitario Infanta Leonor Madrid Spain
Pneumocare Namur Belgium
Asclepius Medical Center OOD Dupnitsa Bulgaria
Diagnostic Consultative Center 1 Lom EOOD Lom Bulgaria
Medical Center Pulmo-2018 EOOD Haskovo Bulgaria
Artromac N.O. Kosice Slovakia
zibp Zentrum fuer Infektiologie Berlin Prenzlauer Berg GmbH Berlin Germany
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Studienpraxis Heimeranplatz Munich Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Aalborg University Hospital Aalborg Denmark
Hospital Universitario Virgen De Valme Sevilla Spain
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Region Midtjylland Aarhus Denmark
Hospital Vithas Xanit Internacional Benalmadena Spain
Anima Alken Belgium
Hospital Alvaro Cunqueiro Vigo Spain
Praxis Ebertplatz Cologne Germany
Region Sjaelland Holbæk Denmark
Medical Center 1 Sevlievo EOOD Sevlievo Bulgaria
Ordinace Hradebni s.r.o. Ceske Budejovice Czechia
Studien Rahman & Detho GmbH Obertshausen Germany
Usxudnoidb Mamglwd Cgnwkm Hinaptiuoxdmiqhud Hamburg Germany
Uenvjhjpazumoecqpdpty Aqapeqno Augsburg Germany
Pvkrv sfwush Presov Slovakia
Vvxof sdejhg Trnava Slovakia
Scizllt Sv sxcyve Nove Mesto Nad Vahom Slovakia
Axeykyplcl Fnp Iatysfkjwf Pcksbdz Mafvclg Agl Dmo Psxuwlu Pawfqwp Pjvm Ez Sofia Bulgaria
Ryhjwd Amqhqose Mstp Av Pernik Bulgaria
Mkcfwby Czwoxe Dujerbns 2abq Ezyg Yambol Bulgaria
Neecnxebcl Bbjxgm Gsp Berlin Germany
Hdgarowb Hyacppov Hillerød Denmark
Psakxfyz aljihxzann Hlpsbtaq souaxx Spisska Nova Ves Slovakia
Kwmmymok dvp Uhblpybduwur Myckyknn Amw Munich Germany
Mcofrpup Mmbwgqx Aobfsqh Pleven Bulgaria
Fpidgrlwc Pjfz Lq Igudrqnvckscd Bbwttbbqy Dxm Hvhvahto Ucoeokuugglhw La Pql Madrid Spain
Mtix Mmnmkmc sngfed Moldava Nad Bodvou Slovakia
Hbnrdfnb Uleyqzsoynbat Hhqmepgu Tsmgy y Ppmovm Idyhcnqo Cgqpjc dpbsvzooehmbxfjrw (gvyt Badalona Spain
Hagkjzja Vvvx dasoepzu Barcelona Spain
Heugmqvf Uwankzvjjutjp dg A Cttyqn A Coruna Galicia Spain

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.

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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