Trial Outcomes & Findings for PBI-0451 (Pomotrelvir) Phase 2 Study in Nonhospitalized Symptomatic Adults With COVID-19 (NCT NCT05543707)
NCT ID: NCT05543707
Last Updated: 2024-12-11
Results Overview
The primary efficacy endpoint was the proportion of participants below LOD for infectious SARS-CoV-2 on Day 3 by IVA from MT nasal swabs for the mITTV analysis set.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
242 participants
Primary outcome timeframe
Day 3
Results posted on
2024-12-11
Participant Flow
Participant milestones
| Measure |
PBI-0451 (Pomotrelvir)
PBI-0451(Pomotrelvir): 2 x 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
PBI-0451 (Pomotrelvir): 2 × 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
|
Placebo
PBI-0451(Pomotrelvir): 2 x placebo to match PBI-0451(Pomotrelvir) tablets administered orally twice daily (BID) with food for 5 days (10 total doses)
Placebo: 2 × placebo to match PBI-0451(Pomotrelvir) tablets administered orally BID with food for 5 days (10 total doses)
|
|---|---|---|
|
Overall Study
STARTED
|
162
|
80
|
|
Overall Study
COMPLETED
|
154
|
77
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
PBI-0451 (Pomotrelvir)
PBI-0451(Pomotrelvir): 2 x 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
PBI-0451 (Pomotrelvir): 2 × 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
|
Placebo
PBI-0451(Pomotrelvir): 2 x placebo to match PBI-0451(Pomotrelvir) tablets administered orally twice daily (BID) with food for 5 days (10 total doses)
Placebo: 2 × placebo to match PBI-0451(Pomotrelvir) tablets administered orally BID with food for 5 days (10 total doses)
|
|---|---|---|
|
Overall Study
Study drug non-compliance/
|
5
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
concurrent illness
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PBI-0451 (Pomotrelvir)
n=162 Participants
PBI-0451(Pomotrelvir): 2 x 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
PBI-0451 (Pomotrelvir): 2 × 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
|
Placebo
n=80 Participants
PBI-0451(Pomotrelvir): 2 x placebo to match PBI-0451(Pomotrelvir) tablets administered orally twice daily (BID) with food for 5 days (10 total doses)
Placebo: 2 × placebo to match PBI-0451(Pomotrelvir) tablets administered orally BID with food for 5 days (10 total doses)
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=162 Participants
|
1 Participants
n=80 Participants
|
2 Participants
n=242 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
161 Participants
n=162 Participants
|
79 Participants
n=80 Participants
|
240 Participants
n=242 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=162 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=242 Participants
|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 12.29 • n=162 Participants
|
42.4 years
STANDARD_DEVIATION 11.75 • n=80 Participants
|
42.6 years
STANDARD_DEVIATION 12.09 • n=242 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=162 Participants
|
42 Participants
n=80 Participants
|
127 Participants
n=242 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=162 Participants
|
38 Participants
n=80 Participants
|
115 Participants
n=242 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
162 Participants
n=162 Participants
|
80 Participants
n=80 Participants
|
242 Participants
n=242 Participants
|
PRIMARY outcome
Timeframe: Day 3Population: The mITTV analysis set included a subset of the mITT anaylsis set who had detectable infectious SARS-CoV-2 at baseline/Day 1.
The primary efficacy endpoint was the proportion of participants below LOD for infectious SARS-CoV-2 on Day 3 by IVA from MT nasal swabs for the mITTV analysis set.
Outcome measures
| Measure |
PBI-0451 (Pomotrelvir)
n=84 Participants
PBI-0451(Pomotrelvir): 2 x 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
PBI-0451 (Pomotrelvir): 2 × 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
|
Placebo
n=39 Participants
PBI-0451(Pomotrelvir): 2 x placebo to match PBI-0451(Pomotrelvir) tablets administered orally twice daily (BID) with food for 5 days (10 total doses)
Placebo: 2 × placebo to match PBI-0451(Pomotrelvir) tablets administered orally BID with food for 5 days (10 total doses)
|
|---|---|---|
|
Virologic Efficacy of PBI-0451 (Pomotrelvir)
|
37 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Day 1-28Population: The safety analysis set included all randomized participants who received ≥ 1 dose of study drug.
Number of treatment-emergent adverse events (AEs), serious adverse events (SAEs), discontinuations due to AEs, and Grade 3 or 4 laboratory abnormalities
Outcome measures
| Measure |
PBI-0451 (Pomotrelvir)
n=161 Participants
PBI-0451(Pomotrelvir): 2 x 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
PBI-0451 (Pomotrelvir): 2 × 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
|
Placebo
n=80 Participants
PBI-0451(Pomotrelvir): 2 x placebo to match PBI-0451(Pomotrelvir) tablets administered orally twice daily (BID) with food for 5 days (10 total doses)
Placebo: 2 × placebo to match PBI-0451(Pomotrelvir) tablets administered orally BID with food for 5 days (10 total doses)
|
|---|---|---|
|
Safety and Tolerability of PBI-0451(Pomotrelvir)
Adverse Events
|
26 events
|
4 events
|
|
Safety and Tolerability of PBI-0451(Pomotrelvir)
Serious Adverse Events
|
1 events
|
0 events
|
|
Safety and Tolerability of PBI-0451(Pomotrelvir)
Discontinuation of study drug due to AEs
|
1 events
|
0 events
|
|
Safety and Tolerability of PBI-0451(Pomotrelvir)
Grade 3 Lab Abnormalities
|
15 events
|
4 events
|
|
Safety and Tolerability of PBI-0451(Pomotrelvir)
Grade 4 Lab Abnormalities
|
1 events
|
3 events
|
SECONDARY outcome
Timeframe: Day 1 - 28Population: Participants who met sustained resolution of symptoms through Day 28
Number of Pomotrelvir treated participants with sustained symptom resolution through Day 28 versus untreated Placebo participants
Outcome measures
| Measure |
PBI-0451 (Pomotrelvir)
n=153 Participants
PBI-0451(Pomotrelvir): 2 x 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
PBI-0451 (Pomotrelvir): 2 × 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
|
Placebo
n=77 Participants
PBI-0451(Pomotrelvir): 2 x placebo to match PBI-0451(Pomotrelvir) tablets administered orally twice daily (BID) with food for 5 days (10 total doses)
Placebo: 2 × placebo to match PBI-0451(Pomotrelvir) tablets administered orally BID with food for 5 days (10 total doses)
|
|---|---|---|
|
Clinical Efficacy of PBI-0451(Pomotrelvir) Versus Placebo Through Study Day 28
|
132 participants
|
66 participants
|
SECONDARY outcome
Timeframe: Day 1-28Population: Numbers reflect subjects with sufficient viral load at baselline for whole genome sequencing.
Presence of SARS-CoV-2 virus, viral RNA or viral antigen based on IVA, quantitative reverse transcriptase polymerase chain reaction (qRT-PCR), and rapid antigen test (RAT), as specified in the Clinical Virology Analysis Plan (CVAP)
Outcome measures
| Measure |
PBI-0451 (Pomotrelvir)
n=53 Participants
PBI-0451(Pomotrelvir): 2 x 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
PBI-0451 (Pomotrelvir): 2 × 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
|
Placebo
n=32 Participants
PBI-0451(Pomotrelvir): 2 x placebo to match PBI-0451(Pomotrelvir) tablets administered orally twice daily (BID) with food for 5 days (10 total doses)
Placebo: 2 × placebo to match PBI-0451(Pomotrelvir) tablets administered orally BID with food for 5 days (10 total doses)
|
|---|---|---|
|
Effect of PBI-0451(Pomotrelvir) on SARS-CoV-2
|
37 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Day 1-28Population: The median number of days to cessation of 14 targeted CVOID-19 symptoms reported at baseline.
The median number of days to sustained resolution of of all 14 COVID-19 symptoms for the PBI-0451 vs Placebo groups through Day 28.
Outcome measures
| Measure |
PBI-0451 (Pomotrelvir)
n=153 Participants
PBI-0451(Pomotrelvir): 2 x 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
PBI-0451 (Pomotrelvir): 2 × 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
|
Placebo
n=77 Participants
PBI-0451(Pomotrelvir): 2 x placebo to match PBI-0451(Pomotrelvir) tablets administered orally twice daily (BID) with food for 5 days (10 total doses)
Placebo: 2 × placebo to match PBI-0451(Pomotrelvir) tablets administered orally BID with food for 5 days (10 total doses)
|
|---|---|---|
|
Clinical Efficacy of PBI-0451(Pomotrelvir) Versus Placebo Through Study Day 1-28
|
10 days
Interval 8.0 to 11.0
|
11 days
Interval 8.0 to 11.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1-28Percentage of participantss with clinical and/or virologic rebound
Outcome measures
| Measure |
PBI-0451 (Pomotrelvir)
n=153 Participants
PBI-0451(Pomotrelvir): 2 x 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
PBI-0451 (Pomotrelvir): 2 × 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
|
Placebo
n=77 Participants
PBI-0451(Pomotrelvir): 2 x placebo to match PBI-0451(Pomotrelvir) tablets administered orally twice daily (BID) with food for 5 days (10 total doses)
Placebo: 2 × placebo to match PBI-0451(Pomotrelvir) tablets administered orally BID with food for 5 days (10 total doses)
|
|---|---|---|
|
Incidence of Rebound SARS-CoV-2 Infection
|
14 Participants
|
2 Participants
|
Adverse Events
PBI-0451 (Pomotrelvir)
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PBI-0451 (Pomotrelvir)
n=162 participants at risk
PBI-0451(Pomotrelvir): 2 x 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
PBI-0451 (Pomotrelvir): 2 × 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
|
Placebo
n=80 participants at risk
PBI-0451(Pomotrelvir): 2 x placebo to match PBI-0451(Pomotrelvir) tablets administered orally twice daily (BID) with food for 5 days (10 total doses)
Placebo: 2 × placebo to match PBI-0451(Pomotrelvir) tablets administered orally BID with food for 5 days (10 total doses)
|
|---|---|---|
|
Gastrointestinal disorders
hemorrhoidal hemorrhage
|
0.62%
1/162 • Number of events 1 • 14 days
|
0.00%
0/80 • 14 days
|
Other adverse events
| Measure |
PBI-0451 (Pomotrelvir)
n=162 participants at risk
PBI-0451(Pomotrelvir): 2 x 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
PBI-0451 (Pomotrelvir): 2 × 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
|
Placebo
n=80 participants at risk
PBI-0451(Pomotrelvir): 2 x placebo to match PBI-0451(Pomotrelvir) tablets administered orally twice daily (BID) with food for 5 days (10 total doses)
Placebo: 2 × placebo to match PBI-0451(Pomotrelvir) tablets administered orally BID with food for 5 days (10 total doses)
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.3%
7/162 • Number of events 7 • 14 days
|
0.00%
0/80 • 14 days
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
3/162 • Number of events 3 • 14 days
|
1.2%
1/80 • Number of events 1 • 14 days
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
2/162 • Number of events 2 • 14 days
|
0.00%
0/80 • 14 days
|
|
Gastrointestinal disorders
Food poisoning
|
1.2%
2/162 • Number of events 2 • 14 days
|
0.00%
0/80 • 14 days
|
|
Renal and urinary disorders
Urinaryl tract infection
|
1.2%
2/162 • Number of events 2 • 14 days
|
0.00%
0/80 • 14 days
|
|
General disorders
Dysgeusia
|
1.2%
2/162 • Number of events 2 • 14 days
|
0.00%
0/80 • 14 days
|
|
Gastrointestinal disorders
other GI
|
1.2%
2/162 • Number of events 2 • 14 days
|
3.8%
3/80 • Number of events 3 • 14 days
|
|
Infections and infestations
other infection
|
1.2%
2/162 • Number of events 2 • 14 days
|
0.00%
0/80 • 14 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place