Ibuzatrelvir for COVID-19

Recruiting at 70 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must be taking: Immunosuppressive therapies

Must not be taking: Other antivirals

Disqualifiers: Dialysis, Active liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 38 days

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment, ibuzatrelvir (a potential antiviral drug), both alone and with remdesivir, for people with COVID-19 who have weakened immune systems. It includes three groups: one taking ibuzatrelvir, one taking remdesivir, and one taking both treatments. Suitable candidates for this trial have COVID-19 symptoms, are not on oxygen, and have conditions like organ transplants or certain cancers that weaken their immune systems. As a Phase 3 trial, this study is the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become available to the wider public.

Do I need to stop my current medications to join the trial?

The trial protocol does not clearly specify if you need to stop your current medications. However, it mentions that you cannot use any prohibited medications or refuse to use required ones, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found all tested doses of ibuzatrelvir to be safe and well-tolerated, with no reports of changes in taste and strong antiviral effects. Research suggests that ibuzatrelvir is unlikely to cause safety issues. Researchers are testing ibuzatrelvir in combination with remdesivir, a known antiviral drug, to evaluate their combined effectiveness. Although this trial is in Phase 3, indicating the treatment has passed some safety checks, the safety of the combination remains under careful evaluation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Ibuzatrelvir is unique because it offers a fresh approach to treating COVID-19 by potentially combining antiviral effects with an oral administration method that could enhance convenience and accessibility for patients. Unlike remdesivir, which is typically administered intravenously, ibuzatrelvir can be taken orally, making it simpler to use, especially outside of hospital settings. Researchers are excited about this treatment because it could provide a faster, more easily distributed option in combating COVID-19, potentially easing the burden on healthcare systems.

What evidence suggests that this trial's treatments could be effective for COVID-19?

Studies have shown that ibuzatrelvir has strong antiviral effects against the virus that causes COVID-19. It blocks a part of the virus needed for multiplication. In lab tests, ibuzatrelvir stopped the virus from spreading. In this trial, participants will receive ibuzatrelvir alone, remdesivir alone, or a combination of both. When combined with remdesivir, another COVID-19 treatment, the two drugs might offer enhanced protection. Previous research suggests that using both treatments together could lower the risk of severe illness, such as requiring a ventilator. These findings indicate that ibuzatrelvir, alone or with remdesivir, could effectively treat COVID-19. ^{1 2 3 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for severely immunocompromised adults with symptomatic COVID-19 who are not hospitalized or are in the hospital but don't need extra oxygen. Participants should have a confirmed case of COVID-19 and meet other health criteria that aren't specified here.

Inclusion Criteria

I am 18 years old or older.

I tested positive for COVID-19 recently and started showing symptoms within the last 5 days.

I am severely immunocompromised due to a condition or treatment I am receiving.

Exclusion Criteria

I have an active liver condition.

I currently need extra oxygen due to COVID-19.

History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either ibuzatrelvir, remdesivir, or both for the treatment of symptomatic COVID-19

38 days

Daily visits for IV administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

10 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ibuzatrelvir

Trial Overview The study is testing the effectiveness and safety of a new medicine called Ibuzatrelvir, alone and combined with Remdesivir, compared to just Remdesivir. It's a Phase 3 trial where patients are randomly assigned treatments in a controlled, double-blinded manner.

How Is the Trial Designed?

Group I: Remdesivir Experimental Treatment 2 Interventions

Participants will receive placebo for ibuzatrelvir orally twice a day + IV remdesivir

Group II: Ibuzatrelvir + Remdesivir Experimental Treatment 2 Interventions

Participants will receive ibuzatrelvir orally twice a day + IV remdesivir

Group III: Ibuzatrelvir Experimental Treatment 2 Interventions

Participants will receive ibuzatrelvir orally twice a day + IV placebo for remdesivir

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39486089/

Virologic Response and Safety of Ibuzatrelvir, A Novel ... Ibuzatrelvir is an orally bioavailable SARS-CoV-2 Mpro inhibitor with demonstrated in vitro antiviral activity and low potential for safety concerns.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07013474

NCT07013474 | A Study to Learn About the ... This study will evaluate the efficacy and safety of ibuzatrelvir with and without remdesivir compared with remdesivir alone for the treatment of symptomatic ...

3. academic.oup.com academic.oup.com/cid/article/80/3/673/7863440

Virologic Response and Safety of Ibuzatrelvir, A Novel SARS ... Ibuzatrelvir is an orally bioavailable SARS-CoV-2 M pro inhibitor with demonstrated in vitro antiviral activity and low potential for safety concerns.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06679140

NCT06679140 | A Study to Learn About ... 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 ...

5. pubs.acs.org pubs.acs.org/doi/10.1021/jacsau.4c00508

A Structural Comparison of Oral SARS-CoV-2 Drug Candidate ... ... results suggests that ibuzatrelvir may prove to be effective against many coronaviral infections. However, the potential emergence of drug ...

6. pfizerclinicaltrials.com pfizerclinicaltrials.com/nct07013474-covid-19-trial

ASPIRE-IC COVID-19 oral antiviral clinical trial for adults ... Ibuzatrelvir may help people with weakened immune systems get better and stay out of the hospital. This clinical trial will evaluate ibuzatrelvir when given ...

7. pubs.acs.org pubs.acs.org/doi/10.1021/acs.jmedchem.3c02469

A Second-Generation Oral SARS-CoV-2 Main Protease ... The clinical safety and efficacy data published for nirmatrelvir/ritonavir, the first in class Mpro inhibitor for COVID-19, shows the attractive nature of this ...