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

Pfizer

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

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

Interventions

NirmatrelvirDRUG

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

RitonavirDRUG

Participants will receive 1 capsule of ritonavir every 12 hours

Placebo for nirmatrelvirDRUG

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.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (11)

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

Outcomes

Primary Outcomes

Change from baseline in SARS-CoV-2 RNA level in nasopharyngeal (NP) swabs

Evaluate effect of nirmatrelvir/ritonavir compared to placebo/ritonavir on SARS-CoV-2 viral RNA levels in NP swabs in hospitalized participants.

Time frame: Day 1 through Day 5

Secondary Outcomes

Time to sustained clinical recovery.

Evaluate effect of nirmatrelvir/ritonavir compared to placebo/ritonavir treatment on clinical outcomes when added to background usual care, for the treatment of severe COVID-19 in hospitalized participants. Time to sustained clinical recovery is defined as the first day during the 30 days after randomization in which a participant attains a score of 1, 2, or 3 on the 8-point ordinal scale (ie, remains alive and is either not hospitalized or is hospitalized but no longer requires ongoing inpatient medical care for COVID-19) for at least 7 consecutive days.

Time frame: Day 1 through Day 30

Proportion of participants with death from any cause or initiation of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)

Time frame: Day 1 through Day 30

Proportion of participants with SARS-CoV-2 RNA <Lower Limit of Quantitation (<LLOQ) (defined as <2.0 log10 copies/mL) in NP swabs

Evaluate effect of nirmatrelvir/ritonavir compared to placebo/ritonavir on SARS-CoV-2 viral RNA levels in NP swabs in hospitalized participants.

Time frame: Day 1 through Day 15

Proportion of participants with sustained NP swab SARS-CoV-2 RNA <LLOQ (defined as <2.0 log10 copies/mL)

To evaluate the effect of nirmatrelvir/ritonavir compared to placebo/ritonavir on SARS-CoV-2 viral RNA levels in NP swabs in hospitalized participants.

Data from ClinicalTrials.gov

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