What side effects are associated with this type of intervention?

Common treatments for COVID-19 include dexamethasone, interferon, lopinavir-ritonavir, and ribavirin. Dexamethasone can cause psychiatric side effects such as depression, emotional lability, euphoria, insomnia, malaise, personality changes, and psychosis. Interferon may lead to flu-like symptoms, fatigue, and depression. Lopinavir-ritonavir can cause gastrointestinal issues like diarrhea, nausea, and liver enzyme abnormalities. Ribavirin is associated with hemolytic anemia and teratogenic effects. These treatments are being evaluated for their safety and pharmacokinetics, similar to the study of PF-07817883.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19, focusing on their safety and pharmacokinetics. Remdesivir, an antiviral drug, was one of the first to receive FDA approval for treating COVID-19 in both hospitalized and nonhospitalized patients. It is administered intravenously and has shown to reduce recovery time in clinical trials. Another notable treatment is the combination of nirmatrelvir and ritonavir (Paxlovid), which is taken orally and has been effective in reducing severe outcomes in high-risk patients. These treatments, like PF-07817883, have undergone rigorous testing to ensure their safety and efficacy in managing COVID-19.

What other types of research exist?

Promising novel alternatives to PF-07817883 for COVID-19 patients include: 1) Convalescent Plasma Transfusion (CPT), which has been used globally and is under continuous investigation for its efficacy. 2) Hydroxychloroquine (HCQ), which has been modeled for dose optimization in specific COVID-19 patients. 3) Bivalent mRNA vaccines, which are recommended as booster doses to improve immunity against SARS-CoV-2 variants. These alternatives have shown varying degrees of efficacy and safety in clinical settings and are being actively studied and recommended.

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PF-07817883 for Liver Disease

Phase 1

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Additional Exclusion Criteria for HI Cohorts Only: Hepatic dysfunction secondary to acute ongoing hepatocellular process

Additional Exclusion Criteria for HI Cohorts Only: Severe ascites and/or pleural effusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 35

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new medicine called PF-07817883 to see if it is safe and how it behaves in adults with different levels of liver health. Participants will receive the medicine, and researchers will take blood samples to understand how the body processes it.

Who is the study for?

Adults aged 18-75 with varying degrees of liver function damage, or no damage at all, are eligible for this study. They must have a BMI between 17.5 to 38 kg/m2 and be able to stay in the clinic for nearly a week. Those with severe health issues like uncontrolled hypertension, recent transplants, or conditions affecting drug absorption cannot participate.

What is being tested?

The trial is testing PF-07817883's safety and how it's processed by adults with different levels of liver function loss. Participants will receive one dose of the medication and undergo blood tests before and after dosing during their clinic stay.

What are the potential side effects?

Since this is a study to learn about the safety profile of PF-07817883, potential side effects are not explicitly listed but may include typical drug-related reactions such as nausea, headaches, allergic reactions or other unforeseen effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have liver dysfunction due to an active liver disease.

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I do not have severe fluid buildup in my abdomen or chest.

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I have never had a kidney, liver, or heart transplant.

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I do not have severe, uncontrolled high blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 35

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 35

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 35 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area Under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf)

Area Under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast)

Maximum Observed Plasma Concentration (Cmax) of PF-07817883

Secondary study objectives

Number of Participants with Clinically Significant Abnormal Laboratory Values

Number of Participants with Clinically Significant Abnormal Vital Signs

Number of Participants with Clinically Significant ECG Abnormalities

+3 more

Side effects data

From 2023 Phase 2 trial • 240 Patients • NCT05799495

Alanine aminotransferase increased

Supraventricular extrasystoles

100%

80%

60%

40%

20%

Study treatment Arm

PF-07817883 300mg

PF-07817883 100mg

PF-07817883 600mg

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment1 Intervention

Severe hepatic impairment

Group II: Cohort 3Experimental Treatment1 Intervention

Moderate hepatic impairment

Group III: Cohort 2Experimental Treatment1 Intervention

Mild hepatic impairment

Group IV: Cohort 1Experimental Treatment1 Intervention

No hepatic impairment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PF-07817883

2022

Completed Phase 2

~370

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for COVID-19, such as antiviral agents, work by inhibiting the replication of the SARS-CoV-2 virus within the host cells. For example, drugs like remdesivir act by targeting the viral RNA polymerase, thereby preventing the virus from multiplying. Monoclonal antibodies, another treatment option, bind to the spike protein of the virus, blocking its entry into human cells. These mechanisms are vital for COVID-19 patients as they help reduce the viral load, alleviate symptoms, and prevent the progression to severe disease, ultimately improving patient outcomes.

Evidence and the Main Adverse Effects Regarding Drug Therapies in the War Against COVID-19.