Clinical trial NCT05545319: 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
Official title: AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED NIRMATRELVIR/RITONAVIR COMPARED WITH PLACEBO/RITONAVIR FOR THE TREATMENT OF SEVERE COVID-19 IN HOSPITALIZED PARTICIPANTS WHO ARE IMMUNOCOMPROMISED OR AT INCREASED RISK FOR SEVERE COVID-19 OUTCOMES
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Coronavirus Disease 2019 (COVID-19)
Immunocompromised
Hospitalization
Child, Hospitalized
Keywords: COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
Ribonucleic acid (RNA) virus Infections
Lung Diseases
Respiratory Tract Diseases
Ritonavir
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms
Pharmacological Action
Anti-human immunodeficiency virus (HIV) Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Paxlovid
Nirmatrelvir
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in SARS-CoV-2 RNA level in nasopharyngeal (NP) swabs
timeFrame: Day 1 through Day 5
Secondary outcomes:
measure: Time to sustained clinical recovery.
timeFrame: Day 1 through Day 30
measure: Proportion of participants with death from any cause or initiation of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
timeFrame: Day 1 through Day 30
measure: Proportion of participants with SARS-CoV-2 RNA <Lower Limit of Quantitation (<LLOQ) (defined as <2.0 log10 copies/mL) in NP swabs
timeFrame: Day 1 through Day 15
measure: Proportion of participants with sustained NP swab SARS-CoV-2 RNA <LLOQ (defined as <2.0 log10 copies/mL)
timeFrame: Day 15 through Day 45
measure: Incidence of Treatment-Related Adverse Events (TEAEs)
timeFrame: Day 1 through Day 45
measure: Incidence of Adverse Events (AEs) or Serious Adverse Events (SAEs) leading to discontinuations
timeFrame: Day 1 through Day 45
Other outcomes:
Locations:
city: Cooperstown
country: United States
facility: Bassett Medical Center
state: New York
city: New York
country: United States
facility: Harlem Hospital Center
state: New York
city: Lom
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Sveti Nikolay Chudotvoretz
state: Montana
city: Kozloduy
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Kozloduy EOOD
state: Vratsa
city: Haskovo
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Haskovo AD
city: Haskovo
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Haskovo EOOD
city: Pernik
country: Bulgaria
facility: "Specialized Hospital for Active Treatment of Lung Diseases - Pernik" EOOD
city: Pleven
country: Bulgaria
facility: "University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
city: Pleven
country: Bulgaria
facility: MHAT - Heart and Brain
city: Plovdiv
country: Bulgaria
facility: "Multiprofile Hospital for Active Treatment - Medical Complex Sveti Ivan Rilski" EOOD
city: Stara Zagora
country: Bulgaria
facility: UMHAT "Prof. Dr. Stoyan Kirkovich"AD
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: