Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).

Phase 2

Terminated

• Conditions: COVID-19
• Interventions: Drug: PF-07321332; Drug: Placebo; Drug: Ritonavir

• Registration Number: NCT05011513
• Lead Sponsor: Pfizer

Brief Summary

The primary hypothesis to be tested is whether or not there is a difference in time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28 between PF-07321332/ritonavir and placebo.

Detailed Description

Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or at another non-clinic location, if available. The total study duration is up to 24 weeks.

Study Timeline

• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-08-16
• Study First Posted: 2021-08-18
• Study Start: 2021-08-25
• Primary Completion: 2022-07-25
• Study Completion: 2022-07-25
• Status Verified: 2023-07
• Results First Submitted: 2023-07-20
• Results First Submitted QC: 2023-07-20
• Last Update Submitted: 2023-07-20
• Results First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1440

Inclusion Criteria

• Confirmed SARS-CoV-2 infection 5 days prior to randomization
• Initial onset of COVID-19 signs/symptoms within 5 days of randomization
• Fertile participants must agree to use a highly effective method of contraception

Exclusion Criteria

• Has at least one underlying medical condition associated with an increased risk of developing severe illness from COVID-19
• History of or need for hospitalization for the medical treatment of COVID-19
• Prior diagnosis of SARS-CoV-2 infection (reinfection)
• Known medical history of liver disease
• Receiving dialysis or have known renal impairment
• Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml or taking prohibited medications for HIV treatment
• Suspected or confirmed concurrent active systemic infection other than COVID-19
• Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
• Has received or is expected to receive monoclonal antibody treatment or convalescent COVID-19 plasma
• Has received any SARS-CoV-2 vaccine within 12 months of screening
• Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
• Known prior participation in this trial or other trial involving PF-07321332
• Oxygen saturation of < 92% on room air
• Females who are pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-07321332/ritonavir	PF-07321332	Orally administered PF-07321332+ritonavir
PF-07321332/ritonavir	Ritonavir	Orally administered PF-07321332+ritonavir
Placebo	Placebo	Orally administered Placebo

Primary Outcome Measures

Name	Time	Method
Time to Sustained Alleviation of Overall COVID-19 Signs and Symptoms Through Day 28	From Day 1 to Day 28	Sustained alleviation of targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. Missing severity at baseline was considered as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported consolidated for overall COVID-19 signs and symptoms.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation	From start of study intervention (Day 1) up to Day 34	An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening ; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity ; congenital anomaly/birth defect; or that was considered as an important medical event. TEAEs were defined as events that started on or after the study medication start date and time. AEs included both serious and all non-serious adverse events. AEs that led to study discontinuation and AEs that led to discontinuation of study intervention and then continued study were also reported in this outcome measure.
Duration of Hospitalization and Intensive Care Unit (ICU) Stay Through Day 28	From Day 1 to Day 28
Percentage of Participants With Progression to Worsening Status of COVID-19 Signs and Symptoms	From Day 1 to Day 28	Participants recorded a daily severity rating of their symptom severity over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe. Vomiting and diarrhea was rated on a 4-point frequency scale where 0 is reported for no occurrence, 1 (mild) for 1 to 2 times, 2 (moderate) for 3 to 4 times, and 3 (severe) for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).
Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28	From Day 1 to Day 28	Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier (KM) method.
Percentage of Participants With Death Through Week 24	From Day 1 to Week 24	Percentage of participants with death (all-cause) event were reported in this outcome measure.
Plasma Concentration Versus Time Summary of PF-07321332	Day 1: 1 hour post dose; Day 5: 0 minutes pre-dose
Number of COVID-19 Related Medical Visits Per Day Through Day 28	From Day 1 to Day 28	Number of COVID-19 related medical visits per day were reported in this outcome measure.
Percentage of Participants With Severe Signs and Symptoms of COVID-19 Through Day 28	From Day 1 to Day 28	Participants recorded a daily severity rating of their symptom severity over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Vomiting and diarrhea each was rated on a 4-point frequency scale where 0 was reported for no occurrence, 1 for 1 to 2 times, 2 for 3 to 4 times, and 3 for 5 or greater. Sense of smell and sense of taste each be rated on a 3-point Likert scale where 0 was reported if the sense of smell/taste was the same as usual, 1 if the sense of smell/taste was less than usual, and 2 for no sense of smell/taste.
Time to Sustained Alleviation of Each COVID-19 Signs and Symptoms Through Day 28	From Day 1 to Day 28	Sustained alleviation of targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. Missing severity at baseline was treated as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported for each COVID-19 signs and symptoms.
Percentage of Participants With Resting Peripheral Oxygen Saturation Greater Than or Equal to (>=) 95% at Day 1 and Day 5	Day 1 and Day 5	Percentage of participants with a resting peripheral oxygen saturation \>=95% were reported in this outcome measure.
Time to Sustained Resolution of Overall COVID-19 Signs and Symptoms Through Day 28	From Day 1 to Day 28	Sustained resolution was defined as when targeted symptoms are scored as absent for 4 consecutive days. The first day of the 4 consecutive-day period was considered the first event date.
Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Days 3, 5, 10 and 14	Baseline, Days 3, 5, 10 and 14	Nasal samples were collected to estimate the viral load in participants in terms of logarithm to base 10 (log10) copies per milliliter.
Time to Sustained Resolution of Each COVID-19 Signs and Symptoms Through Day 28	From Day 1 to Day 28	Sustained resolution was defined as when targeted symptoms are scored as absent for 4 consecutive days. The first day of the 4 consecutive-day period was considered the first event date. In this outcome measure time to sustained resolution is reported consolidated for each COVID-19 signs and symptoms.

Trial Locations

Locations (220)

Cahaba Research Inc; 🇺🇸 Pelham, Alabama, United States

The Institute for Liver Health dba Arizona Clinical Trials; 🇺🇸 Tucson, Arizona, United States

Matrix Mobile Health Clinic #49, #35, and #62; 🇺🇸 Scottsdale, Arizona, United States

Hope Clinical Research; 🇺🇸 Canoga Park, California, United States

Lightship; 🇺🇸 El Segundo, California, United States

Ascada Research; 🇺🇸 Fullerton, California, United States

Atella Clinical Research LLC.; 🇺🇸 La Palma, California, United States

Ark Clinical Research; 🇺🇸 Long Beach, California, United States

South Bay Clinical Research Institute; 🇺🇸 Redondo Beach, California, United States

Benchmark Research; 🇺🇸 Sacramento, California, United States

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