A Study to Learn About a Study Medicine Called Ibuzatrelvir in People With Coronavirus Disease 2019 (COVID-19) and a Severely Compromised Immune System
EU CTIS ID: 2024-517671-21-00
What this study is testing
To compare the efficacy of ibuzatrelvir alone or combined with remdesivir on clinical and virological responses in symptomatic adult participants with COVID-19 who are severely immunocompromised.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening who are non-hospitalized or hospitalized with mild-to-moderate COVID-19. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
- 2. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test as noted in Section 8.2.5) in nasal specimen collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization (see Section 10.10 for criteria). Randomization must occur no later than the fifth day, where the onset of symptoms is the first day. • Participants who are already in the hospital at the time COVID-19 is diagnosed must have at least 1 COVID-19 symptom of moderate or severe intensity present at the time of randomization.
- 3. Severely immunocompromised due to: Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy; Active hematologic malignancy (eg, chronic lymphocytic leukemia, non- Hodgkin lymphoma, multiple myeloma, acute leukemia); Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy; Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing
You likely can't join if
- 1. Severe or critical COVID-19, or current need for supplemental oxygen (for definition of “severe COVID-19” and “critical COVID-19” refer to Appendix 12: COVID-19 Severity Definitions).
- Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.
- Prior participation in this trial or any clinical trial of ibuzatrelvir.
- Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
- 2. Receiving dialysis or have current kidney failure (ie, eGFR consistently <15 mL/min using the serum creatinine-based CKD-EPI formula).
See the full eligibility criteria
Who can join
- 1. 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening who are non-hospitalized or hospitalized with mild-to-moderate COVID-19. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
- 2. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test as noted in Section 8.2.5) in nasal specimen collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization (see Section 10.10 for criteria). Randomization must occur no later than the fifth day, where the onset of symptoms is the first day. • Participants who are already in the hospital at the time COVID-19 is diagnosed must have at least 1 COVID-19 symptom of moderate or severe intensity present at the time of randomization.
- 3. Severely immunocompromised due to: Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy; Active hematologic malignancy (eg, chronic lymphocytic leukemia, non- Hodgkin lymphoma, multiple myeloma, acute leukemia); Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy; Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing
What rules you out
- 1. Severe or critical COVID-19, or current need for supplemental oxygen (for definition of “severe COVID-19” and “critical COVID-19” refer to Appendix 12: COVID-19 Severity Definitions).
- Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.
- Prior participation in this trial or any clinical trial of ibuzatrelvir.
- Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
- 2. Receiving dialysis or have current kidney failure (ie, eGFR consistently <15 mL/min using the serum creatinine-based CKD-EPI formula).
- Active liver disease with AST or ALT >3 ULN, total bilirubin ≥2 × ULN (for Gilbert’s syndrome, direct bilirubin >ULN is exclusionary) within the past 3 months, or liver function impairment with Class C per Child Pugh classification.
- History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator
- Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
- Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- Has received any other antiviral for the treatment of the current COVID-19 infection, including remdesivir, nirmatrelvir/ritonavir, molnupiravir, or mAb treatment (within 30 days or 5 half-lives [whichever is longer] prior to screening), or received convalescent COVID-19 plasma within 12 months. Use of mAb therapy for prevention (eg, pemivibart) of COVID-19 is prohibited within 3 months prior to screening.
- Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). Refer to Section 6.9.
The study team makes the final eligibility decision.
Where it's taking place
- Slovakia
- Germany
- Sweden
- Denmark
- France
- Greece
- Belgium
- Netherlands
- Spain
- Turkey
- Korea, Republic of
- Canada
- Japan
- United States
- Argentina
- Mexico
- Brazil
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Slovakia; Germany; Sweden; Denmark; France; Greece and 12 more locations. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.