Ibuzatrelvir for Coronavirus
Recruiting in Palo Alto (17 mi)
+52 other locations
Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Pfizer
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.
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.
12345Will 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.
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 tested positive for COVID-19 yesterday and started feeling sick within the last 5 days.
Exclusion Criteria
I have been or will be vaccinated for COVID-19 recently.
I am not taking any medications that are not allowed in the study.
I might need to be hospitalized soon due to severe COVID-19 symptoms or other serious health issues.
I am currently experiencing long-term effects from COVID-19.
I do not have any active infections that could affect the study results, except for COVID-19.
My immune system is very weak.
I haven't taken COVID-19 treatments like remdesivir or molnupiravir in the last 30 days.
My liver is not functioning well, with high enzyme levels or severe impairment.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ibuzatrelvirExperimental Treatment1 Intervention
Ibuzatrelvir administered orally every 12 hours (twice daily) for a total of 5 days.
Group II: placeboPlacebo Group1 Intervention
placebo administered orally every 12 hours (twice daily) for 5 days.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Applied Research Center of ArkansasLittle Rock, AR
National Institute of Clinical Research - BakersfieldBakersfield, CA
Long Beach Research InstituteLong Beach, CA
Downtown L.A. Research Center, Inc.Los Angeles, CA
More Trial Locations
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Who is running the clinical trial?
PfizerLead Sponsor
References
Ivermectin: Potential Role as Repurposed Drug for COVID-19. [2021]Severe acute respiratory illness caused by 2019 novel coronavirus (2019-nCoV), officially named severe acute respiratory syndrome coronavirus (SARS-CoV-2) in late December 2019 is an extremely communicable disease. World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19) as a pandemic as it has spread to at least 200 countries in a short span of time. Being a new disease there is lack of information about pathogenesis and proliferation pathways of this new coronavirus. Currently there is no effective treatment for coronavirus infection; major effort is to develop vaccine against the virus and development of therapeutic drugs for the disease. The development of genome-based vaccine and therapeutic antibodies require thorough testing for safety and will be available after some time. In the meanwhile, the available practical approach is to repurpose existing therapeutic agents, with proven safety record as a rapid response measure for the current pandemic. Here we discuss the presently used repurposed drugs for COVID-19 and the potential for ivermectin (IVM) to be used as a therapeutic option in COVID-19.
Interferon β-1a (IFNβ-1a) in COVID-19 patients (INTERCOP): study protocol for a randomized controlled trial. [2023]Pharmacological therapies of proven efficacy in coronavirus disease 2019 (COVID-19) are still lacking. We have identified IFNβ-1a as the most promising drug to be repurposed for COVID-19. The rationale relies on the evidence of IFNβ anti-viral activity in vitro against SARS-CoV-2 and animal models resembling SARS-CoV-2 infection and on a recent clinical trial where IFNβ was indicated as the key component of a successful therapeutic combination.
Nonsteroidal anti-inflammatory drugs (NSAIDs) and nucleotide analog GS-441524 conjugates with potent in vivo efficacy against coronaviruses. [2023]Coronaviruses (CoVs) infect a broad range of hosts, including humans and various animals, with a tendency to cross the species barrier, causing severe harm to human society and fostering the need for effective anti-coronaviral drugs. GS-441524 is a broad-spectrum antiviral nucleoside with potent anti-CoVs activities. However, its application is limited by poor oral bioavailability. Herein, we designed and synthesized several conjugates via covalently binding NSAIDs to 5'-OH of GS-441524 through ester bonds. The ibuprofen conjugate, ATV041, exhibited potent in vitro anti-coronaviral efficacy against four zoonotic coronaviruses in the alpha- and beta-genera. Oral-dosed ATV041 resulted in favorable bioavailability and rapid tissue distribution of GS-441524 and ibuprofen. In MHV-A59 infected mice, ATV041 dose-dependently decreased viral RNA replication and significantly reduced the proinflammatory cytokines in the liver and the lung at 3 dpi. As a result, the MHV-A59-induced lung and liver inflammatory injury was significantly alleviated. Taken together, this work provides a novel drug conjugate strategy to improve oral PK and offers a potent anti-coronaviral lead compound for further studies.
A phase 2/3 study of S-217622 in participants with SARS-CoV-2 infection (Phase 3 part). [2023]Limited treatment options exist for patients with mild-to-moderate coronavirus disease 2019 (COVID-19), irrespective of vaccination history or risk status. Ensitrelvir is a novel oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 3C-like (3CL) protease inhibitor. While phase 2 studies of ensitrelvir have demonstrated promising results in treating mild-to-moderate COVID-19, evaluation of its clinical efficacy due to shifting vaccination status and emergence of the Omicron variant represents significant challenges. Here, we describe the protocol for a phase 3 study designed to evaluate the efficacy and safety of ensitrelvir in patients with mild-to-moderate COVID-19, regardless of risk status or vaccination history.
Structure-based development and preclinical evaluation of the SARS-CoV-2 3C-like protease inhibitor simnotrelvir. [2023]The persistent pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its variants accentuates the great demand for developing effective therapeutic agents. Here, we report the development of an orally bioavailable SARS-CoV-2 3C-like protease (3CLpro) inhibitor, namely simnotrelvir, and its preclinical evaluation, which lay the foundation for clinical trials studies as well as the conditional approval of simnotrelvir in combination with ritonavir for the treatment of COVID-19. The structure-based optimization of boceprevir, an approved HCV protease inhibitor, leads to identification of simnotrelvir that covalently inhibits SARS-CoV-2 3CLpro with an enthalpy-driven thermodynamic binding signature. Multiple enzymatic assays reveal that simnotrelvir is a potent pan-CoV 3CLpro inhibitor but has high selectivity. It effectively blocks replications of SARS-CoV-2 variants in cell-based assays and exhibits good pharmacokinetic and safety profiles in male and female rats and monkeys, leading to robust oral efficacy in a male mouse model of SARS-CoV-2 Delta infection in which it not only significantly reduces lung viral loads but also eliminates the virus from brains. The discovery of simnotrelvir thereby highlights the utility of structure-based development of marked protease inhibitors for providing a small molecule therapeutic effectively combatting human coronaviruses.