Ibuzatrelvir for COVID-19 in Severely Immunocompromised Adults

A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised

Recruiting Phase 3 Interventional Study
COVID-19 Infection
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Pfizer · Industry
Who this trial is looking for

This trial is looking for adults who are severely immunocompromised and have COVID-19. Participants will receive either ibuzatrelvir alone or with another medication to see how well it works against the virus.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am 18 years of age or older
  • I have mild to moderate COVID-19
  • I have confirmed SARS-CoV-2 infection
  • I started having COVID-19 symptoms within the last 5 days
  • I am severely immunocompromised due to a qualifying condition

You may not be able to join if

  • I have severe or critical COVID-19
  • I am currently receiving dialysis
  • I have active liver disease
  • I have a history of serious allergic reactions to study treatments
  • I have a concurrent active infection other than COVID-19
  • My doctor thinks I have less than 30 days to live
  • I have received any other antiviral for my COVID-19
  • I am pregnant or breastfeeding

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial
This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized at baseline with mild-to-moderate CO…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19 2. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attr…
Contacts

Pfizer CT.gov Call Center

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ClinicalTrials.gov_Inquiries@pfizer.com

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