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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Meeting 1 of the 2 categories of COVID-19 risk: - Category A: Immunocompromised - Category B: Non-Immunocompromised, but with ≥2 risk factors - Onset of signs/symptoms attributable to COVID-19 ≤10 days prior to the day of randomization for non-immunocompromised participants (Category B). - Confirmed SARS-CoV-2 infection as determined by Reverse transcription polymerase chain reaction (RT-PCR) or acceptable test method performed by a health care provider in any specimen collected within 48 hours prior to randomization. - Hospitalized for inpatient care for the treatment of clinical manifestations of severe COVID-19. - Requirement for oxygen supplementation (via nasal cannula, mask, non-invasive ventilation [NIV] or high flow oxygen) to maintain SpO2 ≥94% at the time of Screening and Randomization.

Exclusion Criteria

  • Critical illness, defined by ≥1 of the following: - Requirement for mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at randomization, or likely to require intermittent mandatory ventilation (IMV) or ECMO within 12 hours of randomization . - Multi-organ dysfunction/failure. - Hemodynamically unstable, eg. septic shock, cardiac failure or requiring vasopressors. - Participant not expected to survive 24 hours from time of randomization. - History of severe chronic liver disease - Receiving dialysis of any kind or severe renal impairment - Use of nirmatrelvir/ritonavir as an outpatient to treat the current COVID-19 related illness ≤7 days of randomization

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Nirmatrelvir/ritonavir 		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
  • Drug: Nirmatrelvir
    Participants will receive 2 tablets of nirmatrelvir (or 1 tablet for participants with eGFR or eCrCl ≥30 to <60 mL/min) every 12 hours
    Other names:
    • Paxlovid
  • Drug: Ritonavir
    Participants will receive 1 capsule of ritonavir every 12 hours
    Other names:
    • Norvir
Experimental
Placebo/ritonavir 		Participants will receive placebo 0 mg/ritonavir 100 mg every 12 hours for 15 days.
  • Drug: Ritonavir
    Participants will receive 1 capsule of ritonavir every 12 hours
    Other names:
    • Norvir
  • Drug: Placebo for nirmatrelvir
    Participants will receive 2 tablets of placebo for nirmatrelvir (or 1 tablet for participants with eGFR or eCrCl ≥30 to <60 mL/min) every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied.

Recruiting Locations

More Details

NCT ID
NCT05545319
Status
Withdrawn
Sponsor
Pfizer

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.