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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2024-01-06

Brief Summary

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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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Nirmatrelvir

Intervention Type DRUG

Participants will receive 2 tablets of nirmatrelvir (or 1 tablet for participants with eGFR or eCrCl ≥30 to \<60 mL/min) every 12 hours

Ritonavir

Intervention Type DRUG

Participants will receive 1 capsule of ritonavir every 12 hours

Placebo/ritonavir

Participants will receive placebo 0 mg/ritonavir 100 mg every 12 hours for 15 days.

Group Type EXPERIMENTAL

Ritonavir

Intervention Type DRUG

Participants will receive 1 capsule of ritonavir every 12 hours

Placebo for nirmatrelvir

Intervention Type DRUG

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.

Interventions

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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

Intervention Type DRUG

Ritonavir

Participants will receive 1 capsule of ritonavir every 12 hours

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Paxlovid Norvir

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No