Hospitalization Clinical Trial
— EPIC-HOSOfficial 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
Verified date | February 2023 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Bulgaria,
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 |
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