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 (EPIC-HOS)

Pfizer

Status and phase

Withdrawn

Phase 2

Conditions

Child, Hospitalized

Hospitalization

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Coronavirus Disease 2019 (COVID-19)

Immunocompromised

Treatments

Drug: Ritonavir

Drug: Placebo for nirmatrelvir

Drug: Nirmatrelvir

Study type

Interventional

Funder types

Industry

Identifiers

NCT05545319

2022-002447-22 (EudraCT Number)

C4671031

Details and patient eligibility

About

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

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

0 participants in 2 patient groups

Nirmatrelvir/ritonavir

Experimental group

Description:

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

Treatment:

Drug: Ritonavir

Drug: Nirmatrelvir

Placebo/ritonavir

Experimental group

Description:

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

Treatment:

Drug: Placebo for nirmatrelvir

Drug: Ritonavir