Reparixin 1200 mg three times a day as add-on therapy to standard of care to limit disease progression in hospitalised adult patients with COVID-19 and other community-acquired pneumonia.

Reparixin 1200 mg three times a day as add-on therapy to standard of care to limit disease progression in hospitalised adult patients with COVID-19 and other community-acquired pneumonia. A multinational, multicentre, randomised, double-blinded, placebo-controlled, parallel-group phase III trial. (REPAVID-22)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006951-32-AT

Enrollment

526

Registered

2022-01-25

Start date

2022-04-05

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 and other community-acquired pneumonia MedDRA version: 20.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia System Organ Class: 100000004862

Interventions

Product Name: Reparixin Product Code: DF 1681Y Pharmaceutical Form: Tablet INN or Proposed INN: REPARIXIN CAS Number: 266359-83-5 Current Sponsor code: DF 1681Y Concentration unit: mg milligram(s) Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Informed consent signed 2. Male and female adults =18 years old 3. Patients hospitalised for clinically suspected CAP, defined as the occurrence of (within 48h from hospital admission): a) at least 1 of the following signs/symptoms: dyspnea, cough, purulent sputum, crackles (rales) and/or rhonchi b) body temperature > 38°C or local ULN) c) new/increased pulmonary infiltrate(s) by chest imaging 4. Need for non-invasive supplemental oxygen (NIAID-OS 5-6) 5. SpO2 =65 years) yes F.1.3.1 Number of subjects for this age range 376

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria are NOT eligible for inclusion in the study: 1. Treatment with IMV or ECMO (NIAID-OS 7); 2. Hepatic dysfunction: ALT or AST > 5 ULN; history of chronic hepatic disease (defined with ChildPugh score B or C); 3. Renal dysfunction: estimated glomerular filtration rate (eGFR, MDRD) 2 immunosuppressive medications or immunosuppression status (AIDS, aplastic anaemia, asplenia, systemic chemotherapy within the past 3 months, neutropenia (ANC 72h 13. Complicated CAP-associated conditions, such as fungal pulmonary infection, tuberculosis infection, abscess, empyema, significant bilateral pleural effusion, massive pulmonary embolism

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective. To evaluate the efficacy of oral reparixin versus standard care alone in limiting disease progression in adult patients hospitalised for infectious pneumonia acquired in the community (CAP), including COVID-19.;Secondary Objective: Secondary objectives. To determine the effect of reparixin on several disease severity/progression measures including recovery, ventilatory free days and mortality. Safety objectives. To evaluate the safety of oral reparixin versus placebo in the specific clinical setting.;Primary end point(s): Proportion of patients dead or requiring IMV (or ECMO) by day 28;Timepoint(s) of evaluation of this end point: By day 28	—

Measure

Time frame

Main Objective: Primary objective. To evaluate the efficacy of oral reparixin versus standard care alone in limiting disease progression in adult patients hospitalised for infectious pneumonia acquired in the community (CAP), including COVID-19.;Secondary Objective: Secondary objectives. To determine the effect of reparixin on several disease severity/progression measures including recovery, ventilatory free days and mortality. Safety objectives. To evaluate the safety of oral reparixin versus placebo in the specific clinical setting.;Primary end point(s): Proportion of patients dead or requiring IMV (or ECMO) by day 28;Timepoint(s) of evaluation of this end point: By day 28

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Secondary

Measure	Time frame
Secondary end point(s): Key Secondary endpoints: - All-cause mortality at day 180 - Proportion of patients alive and discharged at day 28 - Ventilatory-free days at day 28 - Occurrence of IMV (or ECMO) by day 28 - Length of primary hospital stay Other secondary efficacy endpoints: - Clinical failure (need for IMV/ECMO or vasopressor, or death) by day 3 and day 7 - 28-day ICU-free days - Days free of IMV/ECMO (number of days with NIAID-OS 1-6) at day 28 - Duration of antibiotic therapy (days) at day 28 - 28-day hospital free days - Proportion of patients recovered (downward shift from screening of =2 points on the NIAID-OS or live discharge from hospital) at day 3, 7±1, 14±2, 21±2, 28 ±2 or at hospital discharge - Proportion of patients worsening (upward shift from screening of at least >1 point of the NIAID-OS) at day 3, 7±1, 14±2, 21±2, 28 ±2 or at hospital discharge - PaO2/FiO2, at day 3, 7±1, 14±2, 21±2, 28±2 or at hospital discharge - All-cause mortality, at by day 28, and day 90 - Hospital re-admission by day 90 and 180 - Time to discharge or to a NEWS of = 2 (for 24 hours), whichever occurs first - Change in Inflammatory markers (LDH, CRP, ferritin, D-dimer; PCT) and cytokines [at day 3, 7±1, 14±2, 21±2, 28±2 or at hospital discharge] - Change in quality of life using EQ-5D-5L [90±7 and 180±14 days] - duration of IMV and/or ECMO at 90 and 180d - ICU admission and ICU length of stay at 90 and 180d - hospital length of stay at 90 and 180d - occurrence of infections at 90 and 180d;Timepoint(s) of evaluation of this end point: According to the protocol	—

Measure

Time frame

Secondary end point(s): Key Secondary endpoints: - All-cause mortality at day 180 - Proportion of patients alive and discharged at day 28 - Ventilatory-free days at day 28 - Occurrence of IMV (or ECMO) by day 28 - Length of primary hospital stay Other secondary efficacy endpoints: - Clinical failure (need for IMV/ECMO or vasopressor, or death) by day 3 and day 7 - 28-day ICU-free days - Days free of IMV/ECMO (number of days with NIAID-OS 1-6) at day 28 - Duration of antibiotic therapy (days) at day 28 - 28-day hospital free days - Proportion of patients recovered (downward shift from screening of =2 points on the NIAID-OS or live discharge from hospital) at day 3, 7±1, 14±2, 21±2, 28 ±2 or at hospital discharge - Proportion of patients worsening (upward shift from screening of at least >1 point of the NIAID-OS) at day 3, 7±1, 14±2, 21±2, 28 ±2 or at hospital discharge - PaO2/FiO2, at day 3, 7±1, 14±2, 21±2, 28±2 or at hospital discharge - All-cause mortality, at by day 28, and day 90 - Hospital re-admission by day 90 and 180 - Time to discharge or to a NEWS of = 2 (for 24 hours), whichever occurs first - Change in Inflammatory markers (LDH, CRP, ferritin, D-dimer; PCT) and cytokines [at day 3, 7±1, 14±2, 21±2, 28±2 or at hospital discharge] - Change in quality of life using EQ-5D-5L [90±7 and 180±14 days] - duration of IMV and/or ECMO at 90 and 180d - ICU admission and ICU length of stay at 90 and 180d - hospital length of stay at 90 and 180d - occurrence of infections at 90 and 180d;Timepoint(s) of evaluation of this end point: According to the protocol

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Countries

Argentina, Australia, Austria, Chile, Germany, Italy, Turkey, United States

Contacts

Public ContactClinical Trial Manager

Dompé farmaceutici s.p.a.

cecilia.conz@dompe.com0039023408825229

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026