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New treatment option for COVID-19 SARS-CoV-2 Infection
Official title A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease
ClinicalTrials.gov ID: NCT06679140
What this study is testing
What is ibuzatrelvir?
ibuzatrelvir is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for covid-19 sars-cov-2 infection.
Also referred to as PF-07817883.
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
- The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 12 to \<18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
- Presence of risk factors for progression to severe COVID-19 at the time of screening based on age:
- 12 to 49 years of age with at least two risk factors, where one must be moderate immunocompromise;
- 50 to 64 years of age with at least two risk factors;
- 65 to 74 years of age with at least one risk factor;
You likely can't join if
- Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness (eg, SpO2 \ 30 breaths/minute, or lung...
- Receiving dialysis or have known severe renal impairment [ie, eGFR consistently \<30 mL/min/1.73 m2 for adults or CrCl \<30 mL/min for adolescents]...
- Active liver disease with AST or ALT \>3 ULN, Total bilirubin ≥2 × ULN (for Gilbert's syndrome, direct bilirubin \>ULN is exclusionary) within the...
- Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study...
- Ongoing Long COVID or Post Acute Sequelae of COVID-19 diagnosis.
- Severely immunocompromised.
See the full eligibility criteria
- 12 to \<18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
- Presence of risk factors for progression to severe COVID-19 at the time of screening based on age:
- 12 to 49 years of age with at least two risk factors, where one must be moderate immunocompromise;
- 50 to 64 years of age with at least two risk factors;
- 65 to 74 years of age with at least one risk factor;
- For participants 75 years of age or older, there are no requirements related to risk factors. The list of risk factors includes: BMI ≥35 kg/m2; Current smoker; Chronic lung disease; Cardiovascular disease; Type 1 or...
- Confirmed SARS-CoV-2 infection as determined by RAT in nasal or NP specimen collected within 1 day prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to randomization and at...
- Participants must be unable or unwilling to take nirmatrelvir/ritonavir.
- Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness (eg, SpO2 \ 30 breaths/minute, or lung infiltrates \>50%) or due to other medical conditions requiring...
- Receiving dialysis or have known severe renal impairment [ie, eGFR consistently \<30 mL/min/1.73 m2 for adults or CrCl \<30 mL/min for adolescents], using the serum creatinine-based CKD-EPI formula or the Cockroft...
- 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...
- Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
- Ongoing Long COVID or Post Acute Sequelae of COVID-19 diagnosis.
- Severely immunocompromised.
- Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.
- History of hypersensitivity or other contraindication to any of the components of the study interventions.
- 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...
- Current use of any prohibited concomitant medication(s). 10.Has received any other antiviral for the treatment of COVID-19, including remdesivir, nirmatrelvir/ritonavir, molnupiravir, or COVID-19 mAbs within 30 days or...
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Bakersfield, California, United States
- Huntington Park, California, United States
- Inglewood, California, United States
- Long Beach, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Oxnard, California, United States
- Redding, California, United States
- San Diego, California, United States
- South Gate, California, United States
- Torrance, California, United States
- Wheat Ridge, Colorado, United States
- Washington D.C., District of Columbia, United States
- Clearwater, Florida, United States
- Coconut Creek, Florida, United States
- DeLand, Florida, United States
- Doral, Florida, United States
- Flagami, Florida, United States
- Fort Lauderdale, Florida, United States
+ 185 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 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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Bakersfield, California, United States; Huntington Park, California, United States; Inglewood, California, United States; Long Beach, California, United States; Los Alamitos, California, United States and 199 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.