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Protease Inhibitor

Nirmatrelvir/ritonavir for COVID-19 (EPIC-HOS Trial)

Q: Are there any patients who can participate in this clinical trial at this time?

<p>Unfortunately, this particular trial is not recruiting patients right now. The trial was originally posted on October 7th, 2022, and was last updated three days later. Although this specific trial is not looking for candidates, there are 1184 other clinical trials that are actively recruiting patients.</p>

Q: Has Nirmatrelvir/ritonavir undergone FDA approval process?

<p>Nirmatrelvir/ritonavir is classified as a Phase 2 drug, meaning that while there is evidence that it is safe, there is no evidence of its efficacy. Our team rates its safety at a 2.</p>

Phase 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 15 through day 45

Awards & highlights

EPIC-HOS Trial Summary

This trial will study a medicine used to treat severe COVID-19 in people at high risk of poor outcomes.

Eligible Conditions

COVID-19
Hospitalizations
Hospitalized Children
Immunocompromised

EPIC-HOS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 15 through day 45

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 15 through day 45

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 15 through day 45 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in SARS-CoV-2 RNA level in nasopharyngeal (NP) swabs

Secondary outcome measures

Incidence of Adverse Events (AEs) or Serious Adverse Events (SAEs) leading to discontinuations

Incidence of Treatment-Related Adverse Events (TEAEs)

Proportion of participants with SARS-CoV-2 RNA <Lower Limit of Quantitation (<LLOQ) (defined as <2.0 log10 copies/mL) in NP swabs

+3 more

EPIC-HOS Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo/ritonavirExperimental Treatment2 Interventions

Participants will receive placebo 0 mg/ritonavir 100 mg every 12 hours for 15 days.

Group II: Nirmatrelvir/ritonavirExperimental Treatment2 Interventions

Participants will receive nirmatrelvir/ ritonavir 300 mg/100 mg (or 150 mg/100 mg for participants with estimated glomerular filtration rate (eGFR) or estimated creatinine clearance (eCrCl) ≥30 to <60 mL/min) every 12 hours from Day 1 through Day 15

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nirmatrelvir

2022

Completed Phase 2

~330

Ritonavir

2005

Completed Phase 4

~2200

Placebo for nirmatrelvir

2022

Completed Phase 2

~160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,911,873 Total Patients Enrolled

67 Trials studying COVID-19

1,438,683 Patients Enrolled for COVID-19

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,093,041 Total Patients Enrolled

49 Trials studying COVID-19

1,427,460 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any patients who can participate in this clinical trial at this time?

"Unfortunately, this particular trial is not recruiting patients right now. The trial was originally posted on October 7th, 2022, and was last updated three days later. Although this specific trial is not looking for candidates, there are 1184 other clinical trials that are actively recruiting patients."

Answered by AI

Has Nirmatrelvir/ritonavir undergone FDA approval process?

"Nirmatrelvir/ritonavir is classified as a Phase 2 drug, meaning that while there is evidence that it is safe, there is no evidence of its efficacy. Our team rates its safety at a 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People With Weakened Immune Systems or at Increased Risk for Poor Outcomes Who Are Hospitalized Due to Severe COVID-19

2022. "A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People With Weakened Immune Systems or at Increased Risk for Poor Outcomes Who Are Hospitalized Due to Severe COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05545319.