Phase 3
N=270
Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia.
Pneumonia, Viral
Bottom Line
View on ClinicalTrials.gov: NCT04878055 ↗Enrolled (actual)
270
Serious AEs
12.2%
Results posted
Jun 2024
Primary outcome: Primary: Proportion of Patients Alive and Free of Respiratory Failure at Day 28 — 152; 71 participants — p=0.216
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Reparixin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dompé Farmaceutici S.p.A
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Alive and Free of Respiratory Failure at Day 28 |
152; 71 | 0.216 |
| SECONDARY Proportion of Patients Alive and Free of Respiratory Failure at Day 60 |
141; 66 | 0.377 |
| SECONDARY Mortality Rates up to Day 28 |
10; 7 | 0.17 |
| SECONDARY Incidence of ICU Admission Until Day 28 |
27; 18 | 0.168 |
| SECONDARY Time to Recovery (Category 1 - 2 - 3 of the 7-point WHO Ordinal Scale of Clinical Improvement (WHO-OS)) Until Day 28 |
141; 63 | 0.167 |
| SECONDARY Proportion of Patients Alive and Free of Respiratory Failure at Fixed Timepoints |
179; 87; 171; 79; 160; 73 | 0.55 |
| SECONDARY Mean Changes From Baseline in Clinical Severity Score Based on the 7-point WHO-OS at Fixed Timepoints |
-0.1; 0.0; -0.4; -0.3; -1.7; -1.5 | 0.047 sig |
| SECONDARY Number of Patients With Clinical Improvement 1 up to Day 28 (Decline of 1 Category in the 7-point WHO-OS) |
0; 0; 19; 6; 56; 22 | 0.07 |
| SECONDARY Percentage of Participants With Clinical Improvement 1 up to Day 28 |
87.2; 81.1 | 0.07 |
| SECONDARY Number of Patients With Clinical Improvement 2 up to Day 28 (Decline of 2 Categories in the 7-point WHO-OS) |
0; 0; 0; 0; 19; 6 | 0.668 |
| SECONDARY Percentage of Participants With Clinical Improvement 2 up to Day 28 |
69.9; 67.7 | 0.668 |
| SECONDARY Time to Discharge From Hospital up to Day 28 |
0; 0; 2; 0; 19; 10 | 0.23 |
| SECONDARY Clinical Status Either in Hospital or at Home (7-point WHO-OS) at Fixed Time Points |
0; 0; 0; 0; 5; 1 | 0.444 |
| SECONDARY The Number of Patients With Different Dyspnea Severity Scores Using the Likert Scale at Fixed Timepoints |
1; 0; 1; 3; 5; 1 | 0.997 |
| SECONDARY Change From Baseline to Fixed Timepoints in Pulse Oximetry by Measurement of Peripheral Arterial Oxygen Saturation (SpO2). |
0.79; 0.36; 0.76; 0.49; 0.46; -0.83 | 0.053 |
| SECONDARY Change From Baseline in Dyspnea Severity (VAS Scale) at Fixed Timepoints |
6.4; 2.2; 8.3; -0.2; 12.7; 6.6 | 0.399 |
| SECONDARY Duration of Supplemental Oxygen Treatment up to Day 28 |
10.5; 10.8 | 0.447 |
| SECONDARY Number of Patients Requiring Invasive Mechanical Ventilation Use, or ECMO up to Day 28 and up to Day 60 |
9; 10; 9; 10 | 0.065 |
| SECONDARY Duration of Non-invasive Mechanical Ventilation up to Day 60 |
9.0; 10.1 | 0.485 |
| SECONDARY Duration of Invasive Mechanical Ventilation, or ECMO up to Day 60 |
24.8; 15.9 | 0.267 |
| SECONDARY Duration of ICU Admission up to Day 60 |
17.9; 11.4 | 0.137 |
| SECONDARY Change From Baseline to Fixed Timepoints of Partial Pressure of Oxygen (PaO2) |
13.377; -5.274; 3.147; 12.777; 4.002; -7.257 | 0.002 sig |
| SECONDARY Change From Baseline to Fixed Timepoints in PaO2/FiO2 Ratio. |
30.329; 0.398; 77.528; 65.291; 127.111; 111.220 | 0.005 sig |
| SECONDARY Change From Baseline to Fixed Endpoints in High-Sensitivity C Reactive Protein (Hs-CRP) |
-30.7; -21.67; -25.90; -29.62; -25.21; -45.24 | 0.68 |
| SECONDARY Mortality Rates up to Days 60 and 90 |
11; 7; 11; 7 | 0.232 |
| SECONDARY Freedom From (Time to) Death or Respiratory Failure up to Day 90 |
0; 0; 2; 1; 4; 2 | 0.33607 |
| SECONDARY Number of Subjects Who Exhibited at Least 1 TEAE, at Least 1 Severe TEAE, at Least 1 Serious TEAE, at Least 1 Non-serious TEAE, at Least 1 ADR, at Least 1 Serious ADR, at Least 1 TEAE Leading to Discontinuation of IMP, Etc. |
83; 48; 20; 13; 16; 12 | — |
Summary
The study objective is to assess Efficacy and safety of Reparixin treatment as compared to placebo (both on top of standard treatment) in adult patients with severe COVID-19 pneumonia.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 90, male and female subject of any race
- Reverse transcriptase Polymerase Chain Reaction (rt-PCR)-confirmed COVID-19 infection based on a nasal / oropharyngeal swab within 10 days before randomization
- At least one of the following: 1) Respiratory distress with tachypnea (RR ≥ 24 breaths/min without oxygen); 2) Partial arterial oxygen pressure (PaO2) / Fraction of inspiration O2 (FiO2), P/F >100 and 5 times the upper limit.
- Renal dysfunction with estimated glomerular filtration rate (MDRD) < 50 mL/min/1.73 m2 or patient receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
- Bacterial sepsis (besides COVID-19 sepsis).
- Known congenital or acquired immune deficiency.
- Positive or missing pregnancy test before first drug intake or day 1; pregnant or lactating women; women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study.
Data sourced from ClinicalTrials.gov (NCT04878055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.