Ibuzatrelvir for Coronavirus

Recruiting at 52 trial locations

Overseen By Pfizer CT.gov Call Center

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Pfizer

Must not be taking: Antivirals, COVID-19 mAbs

Disqualifiers: Severe renal impairment, Active liver disease, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

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.

How does the drug Ibuzatrelvir differ from other COVID-19 treatments?

Ibuzatrelvir is unique because it is a 3C-like protease inhibitor, similar to other drugs like ensitrelvir and simnotrelvir, which target a specific enzyme in the coronavirus to prevent it from replicating. This mechanism is different from other treatments like interferon β-1a, which boosts the immune response, or repurposed drugs like ivermectin, which have different modes of action. ^{1 2 3 4 5}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Ibuzatrelvir (Virus Therapy)

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.

Participant Groups

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

Findings from Research

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A phase 2/3 study of S-217622 in participants with SARS-CoV-2 infection (Phase 3 part). [2023]

2. France pubmed.ncbi.nlm.nih.gov

Nonsteroidal anti-inflammatory drugs (NSAIDs) and nucleotide analog GS-441524 conjugates with potent in vivo efficacy against coronaviruses. [2023]

3. Malaysia pubmed.ncbi.nlm.nih.gov

Ivermectin: Potential Role as Repurposed Drug for COVID-19. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Structure-based development and preclinical evaluation of the SARS-CoV-2 3C-like protease inhibitor simnotrelvir. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Interferon β-1a (IFNβ-1a) in COVID-19 patients (INTERCOP): study protocol for a randomized controlled trial. [2023]