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New treatment option for COVID-19 Infection
Official title A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
ClinicalTrials.gov ID: NCT07013474
What this study is testing
What is ibuzatrelvir?
ibuzatrelvir is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for covid-19 infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized for observation or study intervention administration but do not require supplemental oxygen for COVID-19.
- Phase 3: a large, late-stage study
- Time commitment: about 24 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years of age or older at screening who are non-hospitalized or hospitalized for observation or with the intent of administering the study...
- Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of...
- 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);
You likely can't join if
- Severe COVID-19, or current need for supplemental oxygen for treatment of COVID-19.
- Receiving dialysis or have current kidney failure (ie, eGFR consistently \<15 mL/min/1.73 m2)
- Active liver disease
- 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...
- Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.
See the full eligibility criteria
- 18 years of age or older at screening who are non-hospitalized or hospitalized for observation or with the intent of administering the study intervention.
- Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of...
- 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.
- Severe COVID-19, or current need for supplemental oxygen for treatment of COVID-19.
- Receiving dialysis or have current kidney failure (ie, eGFR consistently \<15 mL/min/1.73 m2)
- Active liver disease
- 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...
- Has received any other antiviral for the treatment of the current COVID-19 infection
- Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Canoga Park, California, United States
- Granada Hills, California, United States
- La Jolla, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Hialeah, Florida, United States
- Margate, Florida, United States
- Miami, Florida, United States
- Savannah, Georgia, United States
- Boise, Idaho, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Silver Spring, Maryland, United States
- Boston, Massachusetts, United States
- Burlington, Massachusetts, United States
- Worcester, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
+ 84 more site(s).
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 - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canoga Park, California, United States; Granada Hills, California, United States; La Jolla, California, United States; Sacramento, California, United States; San Diego, California, United States; Aurora, Colorado, United States and 98 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.