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

Hospitalization Clinical Trial

— EPIC-HOS  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05545319
• Other study ID #: C4671031
• Secondary ID: 2022-002447-22
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 13, 2022
• Est. completion date: January 6, 2024

Study information

• Verified date: February 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 6, 2024
• Est. primary completion date: September 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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
• Ritonavir
Participants will receive 1 capsule of ritonavir every 12 hours
• 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.

Locations

Country	Name	City	State
Bulgaria	Multiprofile Hospital for Active Treatment - Haskovo AD	Haskovo
Bulgaria	Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Haskovo EOOD	Haskovo
Bulgaria	Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - Kozloduy EOOD	Kozloduy	Vratsa
Bulgaria	Multiprofile Hospital for Active Treatment - Sveti Nikolay Chudotvoretz	Lom	Montana
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
United States	Bassett Medical Center	Cooperstown	New York
United States	Harlem Hospital Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 through Day 5
Secondary	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.	Day 1 through Day 30
Secondary	Proportion of participants with death from any cause or initiation of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)	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.	Day 1 through Day 30
Secondary	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.	Day 1 through Day 15
Secondary	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.	Day 15 through Day 45
Secondary	Incidence of Treatment-Related Adverse Events (TEAEs)	To describe the safety and tolerability of nirmatrelvir/ritonavir relative to placebo/ritonavir for the treatment of severe COVID-19 in hospitalized participants.	Day 1 through Day 45
Secondary	Incidence of Adverse Events (AEs) or Serious Adverse Events (SAEs) leading to discontinuations	To describe the safety and tolerability of nirmatrelvir/ritonavir relative to placebo/ritonavir for the treatment of severe COVID-19 in hospitalized participants.	Day 1 through Day 45

External Links

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