COVID-19 SARS-CoV-2 Infection study: Ibuzatrelvir
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?
This is an investigational pill being studied to see if it helps treat COVID-19 in people at high risk for getting sicker.
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
- This study checks if ibuzatrelvir is safe and works to prevent mild cases from getting worse.
- Who it's for
- Adults and teenagers with mild COVID-19 who are at high risk of becoming very sick.
- What's involved
- Participants take a pill by mouth for 5 days. They may also receive standard care for their symptoms.
- Time commitment
- The study lasts about 6 months and involves follow-up visits to check on health.
- 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.
- 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
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.
- 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
- Confirmed SARS-CoV-2 infection as determined by RAT in nasal or NP specimen collected within 1 day prior to randomization.
- 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 is enrolling
- Huntsville, Alabama, United States
- 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
- 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
- Doral, Florida, United States
- Flagami, Florida, United States
- Fort Lauderdale, Florida, United States
- Fort Myers, Florida, United States
+ 176 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, 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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Huntsville, Alabama, United States; Little Rock, Arkansas, United States; Bakersfield, California, United States; Huntington Park, California, United States; Inglewood, California, United States; Long Beach, California, United States and 190 more locations. Enter your location above to see the nearest enrolling 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 ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.