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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Coronavirus Disease 2019 (COVID-19), Immunocompromised, Hospitalization, Child, Hospitalized

In brief

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

Key facts

Study ID

NCT05545319

Run by

Pfizer

People needed

0

Starts

2022-12-13

Expected to finish

2024-01-06

Last updated by the study team

2023-03-01

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Bassett Medical Center — Cooperstown, New York, United States
• Harlem Hospital Center — New York, New York, United States
• Multiprofile Hospital for Active Treatment - Sveti Nikolay Chudotvoretz — Lom, Montana, Bulgaria
• Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Kozloduy EOOD — Kozloduy, Vratsa, Bulgaria
• Multiprofile Hospital for Active Treatment - Haskovo AD — Haskovo, Bulgaria
• Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Haskovo EOOD — Haskovo, Bulgaria
• "Specialized Hospital for Active Treatment of Lung Diseases - Pernik" EOOD — Pernik, Bulgaria
• "University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD — Pleven, Bulgaria
• MHAT - Heart and Brain — Pleven, Bulgaria
• "Multiprofile Hospital for Active Treatment - Medical Complex Sveti Ivan Rilski" EOOD — Plovdiv, Bulgaria
• UMHAT "Prof. Dr. Stoyan Kirkovich"AD — Stara Zagora, Bulgaria

Full record on ClinicalTrials.gov

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