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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | 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
