Ibuzatrelvir for Coronavirus

Recruiting at 245 trial locations

Overseen By Pfizer CT.gov Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must not be taking: Antivirals, COVID-19 mAbs

Disqualifiers: Severe renal impairment, Active liver disease, others

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: Unknown

Duration: 5 days

2330 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ibuzatrelvir, a potential antiviral drug, to determine its effectiveness for people with COVID-19 who are not hospitalized but are at high risk of severe illness. Participants will receive either ibuzatrelvir or a placebo (a pill resembling the treatment but without the active drug) for five days. Suitable candidates have a confirmed COVID-19 infection, symptoms that began within the last five days, and risk factors such as smoking or diabetes. The trial aims to assess the treatment's effectiveness and safety. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot use any prohibited medications. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that ibuzatrelvir is likely to be safe for humans?

Research has shown that ibuzatrelvir is generally safe and well-tolerated. In earlier studies, all tested doses of ibuzatrelvir caused no major safety problems. Participants experienced no unusual taste changes, a common side effect with some medications. The drug also demonstrated strong antiviral activity, effectively fighting the virus. Additionally, lab studies suggest that ibuzatrelvir is unlikely to raise safety concerns. While these findings are promising, they are based on past research and not the current trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-19?

Ibuzatrelvir is unique because it offers a new approach to treating coronavirus infections. While most current treatments like antivirals work by targeting the virus's replication process, ibuzatrelvir is designed to be taken orally and works by disrupting the virus's ability to multiply at a cellular level. This could potentially lead to faster improvement in symptoms compared to existing options. Researchers are excited about ibuzatrelvir because it promises a quicker, more direct attack on the virus, potentially reducing the duration and severity of illness.

What evidence suggests that ibuzatrelvir might be an effective treatment for COVID-19?

Research shows that ibuzatrelvir is a pill targeting a specific part of the coronavirus, helping to stop it from multiplying. In lab tests, ibuzatrelvir has demonstrated a strong ability to fight COVID-19 and appears to be safe. It effectively blocks the virus in test tubes and seems safe for use. In this trial, participants will receive either ibuzatrelvir or a placebo to evaluate its effectiveness and safety in treating COVID-19. Although more research is needed to confirm its efficacy in people, these early results are promising. ^{1 2 3 4 6}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Adults and adolescents with COVID-19, not hospitalized but at high risk for severe disease. Ages 12-17 must weigh at least 40 kg; ages 18+ can be any weight. Participants need confirmed COVID-19, symptoms within the past 5 days, and specific risk factors like obesity, smoking, chronic diseases or moderate immunosuppression.

Inclusion Criteria

I cannot or do not want to take nirmatrelvir/ritonavir.

I am at a higher risk for severe COVID-19 due to my age.

I am either 12-17 years old weighing at least 40 kg, or I am 18 or older.

Exclusion Criteria

I have been or will be vaccinated for COVID-19 recently.

Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir

I am not taking any medications that are not allowed in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ibuzatrelvir or placebo orally every 12 hours for 5 days

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ibuzatrelvir

Trial Overview

The trial is testing Ibuzatrelvir's effectiveness in preventing severe COVID-19 compared to a placebo. Participants will take the study medicine or placebo orally for five days while continuing standard care treatments.

How Is the Trial Designed?

Group I: ibuzatrelvir Experimental Treatment 1 Intervention

Ibuzatrelvir administered orally every 12 hours (twice daily) for a total of 5 days.

Group II: placebo Placebo Group 1 Intervention

placebo administered orally every 12 hours (twice daily) for 5 days.

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

Published Research Related to This Trial

A phase 3 study is being conducted to evaluate the efficacy and safety of ensitrelvir, a novel oral protease inhibitor, in treating mild-to-moderate COVID-19 in patients regardless of their vaccination status or risk factors.

Preliminary results from a phase 2b study indicated that ensitrelvir reduced the time to resolution of COVID-19 symptoms compared to placebo, suggesting it may be an effective treatment option for patients with mild-to-moderate disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 2/3 study of S-217622 in participants with SARS-CoV-2 infection (Phase 3 part). Yotsuyanagi, H., Ohmagari, N., Doi, Y., et al.[2023]

The INTERCOP trial is investigating the efficacy of IFNβ-1a in treating COVID-19 in 126 patients with mild-to-moderate disease, focusing on its ability to speed up the negative conversion of SARS-CoV-2 and improve clinical outcomes.

IFNβ-1a has shown promise due to its antiviral activity against SARS-CoV-2 in previous studies, and if proven effective and safe, it could become a key treatment option for COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interferon β-1a (IFNβ-1a) in COVID-19 patients (INTERCOP): study protocol for a randomized controlled trial. Bosi, E., Bosi, C., Rovere Querini, P., et al.[2023]

The newly synthesized ibuprofen conjugate, ATV041, significantly enhances the oral bioavailability and tissue distribution of the antiviral drug GS-441524, making it a promising candidate for treating coronaviruses.

In mouse models infected with MHV-A59, ATV041 effectively reduced viral RNA replication and inflammation in the liver and lungs, suggesting its potential to alleviate damage caused by coronavirus infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonsteroidal anti-inflammatory drugs (NSAIDs) and nucleotide analog GS-441524 conjugates with potent in vivo efficacy against coronaviruses. Zhou, Q., Luo, Y., Zhu, Y., et al.[2023]

COVID-19, caused by the SARS-CoV-2 virus, is a highly contagious disease that has led to a global pandemic, prompting urgent efforts to develop vaccines and therapeutic drugs.

While there is currently no effective treatment for COVID-19, repurposing existing drugs with established safety records, such as ivermectin, is being explored as a potential therapeutic option during the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ivermectin: Potential Role as Repurposed Drug for COVID-19. Dixit, A., Yadav, R., Singh, AV.[2021]

Simnotrelvir is a newly developed oral inhibitor targeting the SARS-CoV-2 3C-like protease, showing strong potential as a treatment for COVID-19, especially when combined with ritonavir.

In preclinical studies, simnotrelvir demonstrated high selectivity and efficacy against various SARS-CoV-2 variants, significantly reducing viral loads in the lungs and eliminating the virus from the brains of infected mice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structure-based development and preclinical evaluation of the SARS-CoV-2 3C-like protease inhibitor simnotrelvir. Jiang, X., Su, H., Shang, W., et al.[2023]

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.

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.

3.

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 ...

4.

pfizerclinicaltrials.com

pfizerclinicaltrials.com/find-a-trial/nct06679140-covid-19-sars-cov-2-infection-trial

Clinical Trial for COVID-19 SARS-CoV-2 Infection.

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.

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 ...

6.

pfizerclinicaltrials.com

pfizerclinicaltrials.com/nct07013474-covid-19-trial

ASPIRE-IC COVID-19 oral antiviral clinical trial for adults ...

That is why we are researching a potential medication (ibuzatrelvir) to determine if it is safe and effective for adults who are at increased risk of prolonged ...