Adults 18 to 90, any sex, with Severe Pneumonia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase 2 - Percentage of Participants With Composite Endpoint of Clinical EventsPrimary· Up to Day 1
Composite event is defined as the onset of at least one of the following events:
* supplemental oxygen requirement based on a worsening of PaO2/FiO2 ratio,
* invasive mechanical ventilation use,
* admission to Intensive Care Unit (ICU),
* use of a rescue medication for any reason. Please note that in the measure type "number" actually is a "rate" of patients. Rate is referred to a binomial response rate while the 95% CIs are estimated by using the Clopper-Pearson's method
Composite event
Group
Value
95% CI
Reparixin (FAS)
16.7
6.4 – 32.8
Standard of Care (FAS)
42.1
20.3 – 66.5
Supplemental oxygen requirement based on PaO2/FiO2
Group
Value
95% CI
Reparixin (FAS)
13.9
4.7 – 29.5
Standard of Care (FAS)
26.3
9.1 – 51.2
Invasive Mechanical ventilation
Group
Value
95% CI
Reparixin (FAS)
2.8
0.1 – 14.5
Standard of Care (FAS)
5.3
0.1 – 26.0
Admission to ICU
Group
Value
95% CI
Reparixin (FAS)
2.8
0.1 – 14.5
Standard of Care (FAS)
0.0
0.0 – 17.6
Use of a rescue medication for any reason
Group
Value
95% CI
Reparixin (FAS)
0.0
0.0 – 9.7
Standard of Care (FAS)
26.3
9.1 – 51.2
Phase 2 - Percentage of Patients With Improvement in Clinical Severity Score (as Recommended by WHO for COVID Studies) of at Least Two PointsSecondary· At day 1, day 2, week 1, day 21(end of treatment, EOT), EOS (end of study, i.e. 7±3 days after EOT)
Changes in clinical severity score are defined as the time to clinical improvement of two points from the time of randomization on a seven-category ordinal scale or live discharge from the hospital, whichever came first. The seven-category ordinal scale consisted of the following: 1) not hospitalized, with resumption of normal activities; 2) not hospitalized, but unable to resume normal activities; 3) hospitalized, not requiring supplemental oxygen; 4) hospitalized, requiring supplemental oxygen; 5) hospitalized, requiring high-flow oxygen therapy, non-invasive mechanical ventilation, or both;
Day 1
Group
Value
95% CI
Reparixin (FAS)
0.0
0.0 – 10.0
Standard of Care (FAS)
0.0
0.0 – 17.6
Day 2
Group
Value
95% CI
Reparixin (FAS)
0.0
0.0 – 10.0
Standard of Care (FAS)
0.0
0.0 – 18.5
Week 1
Group
Value
95% CI
Reparixin (FAS)
23.5
10.7 – 41.2
Standard of Care (FAS)
17.6
3.8 – 43.4
EOT
Group
Value
95% CI
Reparixin (FAS)
26.5
12.9 – 44.4
Standard of Care (FAS)
26.3
9.1 – 51.2
EOS
Group
Value
95% CI
Reparixin (FAS)
61.5
40.6 – 79.8
Standard of Care (FAS)
55.6
21.2 – 86.3
Phase 2 - Percentage of Improved Subjects in Dyspnea Severity, Assessed by Liker ScaleSecondary· Baseline, day 1, day 2, week 1, day 21(end of treatment, EOT), 7±3 days after treatment period (end of study, EOS)
The severity of dyspnea can be measured through the Liker scale. The Liker scale is used as follows: the patient grades his current breathing compared to when he first started the drug (from -3 to 3). "0" = no change, "1" =minimally better, "2" =moderately better, "3" =markedly better, "-1" =minimally worse, "-2" =moderately worse, "-3" =markedly worse. The higher the score, the better the outcome. N is the number of subjects for which the evaluation of the dyspnea severity scale at each time point is available. n is the number of subjects improved at each time point in comparison with the ran
Baseline
Group
Value
95% CI
Reparixin (FAS)
0
Standard of Care (FAS)
1
Day 1
Group
Value
95% CI
Reparixin (FAS)
7
Standard of Care (FAS)
2
Day 2
Group
Value
95% CI
Reparixin (FAS)
12
Standard of Care (FAS)
2
Week 1
Group
Value
95% CI
Reparixin (FAS)
23
Standard of Care (FAS)
6
EOT
Group
Value
95% CI
Reparixin (FAS)
20
Standard of Care (FAS)
6
EOS
Group
Value
95% CI
Reparixin (FAS)
16
Standard of Care (FAS)
3
Phase 2 - Change From Baseline in Dyspnea Severity, Assessed by VAS ScaleSecondary· Baseline, day 1, day 2, week 1, day 21(end of treatment, EOT), 7±3 days after treatment period (end of study, EOS)
The severity of dyspnea is measured also through the VAS scale. The VAS scale is used as follows: the patient draws a horizontal line on an axial graph (from 0 to 100) to show the degree of how he feels about breathing. The number "0" equals the worst breathing the patient has ever felt and the number "100" equals the best he has ever felt. N is the number of subjects for which the evaluation of the dyspnea severity scale at each time point is available. n is the number of subjects improved at each time point in comparison with the randomization.
Baseline
Group
Value
95% CI
Reparixin (FAS)
56.9
± 37.3
Standard of Care (FAS)
4.0
± 5.5
to Day 1
Group
Value
95% CI
Reparixin (FAS)
4.3
± 8.5
Standard of Care (FAS)
20.0
± 40.0
to Day 2
Group
Value
95% CI
Reparixin (FAS)
32.3
± 40.3
Standard of Care (FAS)
44.8
± 51.7
Week 1
Group
Value
95% CI
Reparixin (FAS)
29.0
± 34.0
Standard of Care (FAS)
86.0
± 5.3
EOT
Group
Value
95% CI
Reparixin (FAS)
33.0
± 41.8
Standard of Care (FAS)
89.7
± 0.6
EOS
Group
Value
95% CI
Reparixin (FAS)
22.5
± 31.8
Changes From Baseline in Body Temperature to Any Post-baseline TimepointsSecondary· Baseline, Day 1, Day 2, Week 1, EOT and EOS
Variations in the mean body temperature from baseline to any post-baseline timepoint were assessed.
n is the number of subjects for which the evaluation of the body temperature at each time point is available.
Baseline
Group
Value
95% CI
Reparixin (FAS)
36.4
± 0.5
Standard of Care (FAS)
36.5
± 0.5
to Day 1
Group
Value
95% CI
Reparixin (FAS)
-0.2
± 0.5
Standard of Care (FAS)
0.2
± 0.9
to Day 2
Group
Value
95% CI
Reparixin (FAS)
-0.1
± 0.7
Standard of Care (FAS)
-0.1
± 0.6
to Week 1
Group
Value
95% CI
Reparixin (FAS)
-0.1
± 0.6
Standard of Care (FAS)
-0.2
± 0.6
to EOT
Group
Value
95% CI
Reparixin (FAS)
-0.2
± 0.6
Standard of Care (FAS)
-0.4
± 0.6
to EOS
Group
Value
95% CI
Reparixin (FAS)
-0.1
± 0.5
Standard of Care (FAS)
-0.5
± 0.6
Phase 2 - Percentage of Subjects Worsened, During Supplemental Oxygen Treatment, From Randomization According to PaO2/FiO2Secondary· At day 1, day 2, week 1, day 21(end of treatment), follow-up (FU) (7±3 days after treatment period)
Cumulative quantity of oxygen treatment (L) = Sum of all Quantity (L) in CONCOMITANT OXYGEN TREATMENT form, from randomization to time point of interest.
According to PaO2/FiO2, the classification is 'mild' if 200 \<= PaO2/FiO2 \< 300 mmHg, 'moderate' if 100 \<= PaO2/FiO2 \< 200 mmHg, 'severe' if PaO2/FiO2 \< 100 mmHg. A patient with ARDS (PaO2/FiO2\<300 mmHg) is considered 'worsened' in case of a decrease of PaO2/FiO2 of at least one third (-33,3%) from the baseline PaO2/FiO2 value.
NOTE that: N is the number of subjects for which the evaluation of the PaO2/FiO2 ratio at each time point is
Day 1 - subjects worsened (%)
Group
Value
95% CI
Reparixin (FAS)
7.4
0.9 – 24.3
Standard of Care (FAS)
14.3
1.8 – 42.8
Day 2 - subjects worsened (%)
Group
Value
95% CI
Reparixin (FAS)
12.9
3.6 – 29.8
Standard of Care (FAS)
20.0
4.3 – 48.1
Week 1 - subjects worsened (%)
Group
Value
95% CI
Reparixin (FAS)
0.0
0.0 – 13.2
Standard of Care (FAS)
21.4
4.7 – 50.8
EOT - subjects worsened (%)
Group
Value
95% CI
Reparixin (FAS)
0.0
0.0 – 11.9
Standard of Care (FAS)
8.3
0.2 – 38.5
EOS - subjects worsened (%)
Group
Value
95% CI
Reparixin (FAS)
0.0
0.0 – 30.8
Standard of Care (FAS)
0.0
0.0 – 70.8
Phase 2 - Percentage of Subjects Worsened, During Supplemental Oxygen Treatment, From Randomization According to Oxygen Delivery System ClassificationSecondary· day 1, day 2, week 1, day 21(end of treatment), follow-up (FU) (7±3 days after treatment period)
Duration of oxygen administration (hours) = Administration end date/time - Administration start date/time / 60. N is the number of subjects for which the evaluation of the Oxygen Delivery System Classification at each time point is available. n is the number of subjects worsened at each time point, expressed in percentage, in comparison with the randomization. According to Oxygen Delivery System, the classification is 'invasive' if there is Invasive Medicinal Ventilation or ECMO, else 'high flow' if there is High Flow Nasal Cannula or BIPAP or CPAP, else 'low flow' if there is Nasal Cannula or
Day 1 - subjects worsened
Group
Value
95% CI
Reparixin (FAS)
5.6
0.7 – 18.7
Standard of Care (FAS)
0.0
0.0 – 17.6
Day 2 - subjects worsened
Group
Value
95% CI
Reparixin (FAS)
5.6
0.7 – 18.7
Standard of Care (FAS)
5.3
0.1 – 26.0
Week 1 - subjects worsened
Group
Value
95% CI
Reparixin (FAS)
2.9
0.1 – 15.3
Standard of Care (FAS)
17.6
3.8 – 43.4
EOT - subjects worsened
Group
Value
95% CI
Reparixin (FAS)
2.9
0.1 – 14.9
Standard of Care (FAS)
15.8
3.4 – 39.6
EOS - subjects worsened
Group
Value
95% CI
Reparixin (FAS)
3.6
0.1 – 18.3
Standard of Care (FAS)
8.3
0.2 – 38.5
Phase 2 - Oxygen Cumulative Duration During the StudySecondary· Week 1, EOT, EOS
This outcome assesses the oxygen cumulative duration during the study. N is the number of subjects for which the evaluation of the PaO2/FiO2 ratio or Oxygen Delivery System Classification at each time point is available. n is the number of subjects worsened at each time point in comparison with the randomization.
week 1
Group
Value
95% CI
Reparixin (FAS)
141.93
± 55.68
Standard of Care (FAS)
130.22
± 80.89
EOT
Group
Value
95% CI
Reparixin (FAS)
151.55
± 75.53
Standard of Care (FAS)
134.00
± 86.21
EOS
Group
Value
95% CI
Reparixin (FAS)
195.26
± 198.62
Standard of Care (FAS)
155.71
± 135.93
Phase 2 - Oxygen Cumulative Quantity During the StudySecondary· Week 1, EOT and EOS
In this endpoint is assessed the oxygen cumulative quantity needed at each single timepoint.
N is the number of subjects for which the evaluation of the PaO2/FiO2 ratio or Oxygen Delivery System Classification at each time point is available. n is the number of subjects worsened at each time point in comparison with the randomization.
Week 1
Group
Value
95% CI
Reparixin (FAS)
24.99
± 22.22
Standard of Care (FAS)
29.20
± 29.51
EOT
Group
Value
95% CI
Reparixin (FAS)
25.64
± 22.16
Standard of Care (FAS)
29.73
± 31.53
EOS
Group
Value
95% CI
Reparixin (FAS)
26.54
± 22.31
Standard of Care (FAS)
33.38
± 31.64
Phase 2 - Percentage of Subjects Requiring Mechanical Ventilation Use, OverallSecondary· Baseline, day 1, day 2, week 1, day 21(end of treatment), follow-up (FU) (7±3 days after treatment period)
Percentage along with the 95% confidence interval (Clopper-Pearson's formula) of subjects requiring mechanical ventilation are calculated and compared. N is the number of subjects for which the evaluation of the use of mechanical ventilation is available. n is the number, expressed in percentage, of subjects requiring mechanical ventilation, overall.
Baseline - subjects requiring
Group
Value
95% CI
Reparixin (FAS)
11.1
3.1 – 26.1
Standard of Care (FAS)
10.5
1.3 – 33.1
Day1 - subjects requiring
Group
Value
95% CI
Reparixin (FAS)
11.1
3.1 – 26.1
Standard of Care (FAS)
10.5
1.3 – 33.1
Day 2 - subjects requiring
Group
Value
95% CI
Reparixin (FAS)
11.4
3.2 – 26.7
Standard of Care (FAS)
16.7
3.6 – 41.4
Week 1- subjects requiring
Group
Value
95% CI
Reparixin (FAS)
8.8
1.9 – 23.7
Standard of Care (FAS)
11.8
1.5 – 36.4
EOT - subjects requiring
Group
Value
95% CI
Reparixin (FAS)
8.6
1.8 – 23.1
Standard of Care (FAS)
5.3
0.1 – 26.0
EOS -subjects requiring
Group
Value
95% CI
Reparixin (FAS)
0.0
0.0 – 12.8
Standard of Care (FAS)
0.0
0.0 – 30.8
Phase 2 - Cumulative Duration of Mechanical Ventilation Use, OverallSecondary· Baseline, day 1, day 2, week 1, day 21(end of treatment), follow-up (FU) (7±3 days after treatment period)
Cumulative duration of mechanical ventilation (in hours) = Sum of duration of mechanical ventilation (hours) in mechanical ventilation form, from randomization to time point of interest.
Duration of mechanical ventilation (hours) = End date/time - Start date/time / 60. n is the number of subjects for which the evaluation of the use of mechanical ventilation is available
Week 1
Group
Value
95% CI
Reparixin (FAS)
162.54
± 58.92
Standard of Care (FAS)
142.42
± 44.89
EOT
Group
Value
95% CI
Reparixin (FAS)
149.99
± 53.23
Standard of Care (FAS)
146.86
± 43.80
EOS
Group
Value
95% CI
Reparixin (FAS)
179.51
± 78.30
Standard of Care (FAS)
154.86
± 56.52
Phase 2 - Percentage of Subjects With Intensive Care Unit (ICU) Admission NeedSecondary· Baseline, day 1, day 2, week 1, day 21(end of treatment), follow-up (FU) (7±3 days after treatment period)
Percentage, along with the 95% confidence interval (Clopper-Pearson's formula), of subjects requiring ICU admission are calculated and compared.N is the number of subjects for which the evaluation of the ICU admission need is available.
Baseline - subjects admitted to ICU
Group
Value
95% CI
Reparixin (FAS)
2.8
0.1 – 14.5
Standard of Care (FAS)
5.3
0.1 – 26.0
Day 1 - subjects admitted to ICU
Group
Value
95% CI
Reparixin (FAS)
2.8
0.1 – 14.5
Standard of Care (FAS)
5.3
0.1 – 26.0
Day 2 - subjects admitted to ICU
Group
Value
95% CI
Reparixin (FAS)
5.7
0.7 – 19.2
Standard of Care (FAS)
5.6
0.1 – 27.3
Week 1 - subjects admitted to ICU
Group
Value
95% CI
Reparixin (FAS)
2.9
0.1 – 15.3
Standard of Care (FAS)
0.0
0.0 – 19.5
EOT - subjects admitted to ICU
Group
Value
95% CI
Reparixin (FAS)
2.9
0.1 – 14.9
Standard of Care (FAS)
0.0
0.0 – 17.6
EOS - subjects admitted to ICU
Group
Value
95% CI
Reparixin (FAS)
0.0
0.0 – 30.8
Standard of Care (FAS)
0.0
0.0 – 12.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Throughout the study, till day 21.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
* Phase 2 Study Objectives: efficacy and safety of of Reparixin treatment as compared to the control arm in adult patients with severe COVID-19 pneumonia
* Phase 3 Study Objectives: efficacy and safety of Reparixin treatment as compared to the control arm in adult patients with moderate or severe COVID-19 pneumonia
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05254990 — Reparixin add-on Therapy to Standard Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia
· Phase 3
· terminated
NCT04878055 — Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia.
· Phase 3
· completed
NCT02370238 — A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer
· Phase 2
· completed
NCT03031470 — Pilot Study of Reparixin for Early Allograft Dysfunction Prevention in Liver Transplantation
· Phase 2
· terminated
NCT07461714 — AI-Driven Accurate Diagnosis of Pathogens in Severe Pneumonia
· active not recruiting
NCT06538441 — Dynamic Pattern of Etiology, Immunoinflammatory Factors and Their Association With Prognosis of Severe Pneumonia
· active not recruiting
NCT06514781 — The Application of Different Sedation Protocols in ICU Patients With Severe Pneumonia
· recruiting
NCT06114784 — Microbiome and Host Susceptibility in Severe Pneumonia, a Prospective, Multicenter, Cohort Study
· recruiting
NCT06516601 — Fulminant Severe CAP - an Observational Study
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dompé Farmaceutici S.p.A
Last refreshed: 8 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04794803.