Reparixin in COVID-19 Pneumonia - Efficacy and Safety

NCT ID: NCT04794803

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-05
• Study Completion Date: 2021-02-02

Brief Summary

• 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

Detailed Description

This clinical trial is an adaptive phase 2/3, randomized, controlled multicenter study on the efficacy and safety of Reparixin in the treatment of hospitalized patients with COVID-19 pneumonia. 48 patients are planned to be enrolled in Phase 2 and an estimated total of 111 patients are planned to be enrolled up to the end of Phase 3, with a randomization 2:1 Reparixin vs Control (Standard of care).

In the phase 2 segment of this study, patients are randomized 2:1 to Reparixin oral tablets 1200 mg (Group 1, active treatment) or standard of care (Group 2, control arm). In case of worsening (e.g. need of ICU and/or mechanical ventilation) after the first 24hrs, patients are offered a rescue medication with no restriction from the sponsor and fully based on their physicians' judgement.

In the phase 3 segment of this study, it is planned that patients are randomized 2:1 to Reparixin or standard of care. The Phase 3 design will be reassessed and decided based on the results of the Phase 2.

Conditions

Severe Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reparixin

Reparixin oral tablets 1200 mg TID for 7 days

Group Type: EXPERIMENTAL

Reparixin

Intervention Type: DRUG

Reparixin was administered via oral tablets 1200 mg TID for 7 days. In case of improvement, treatment can be prolonged at discretion of the investigator up to a maximum of 21 days of treatment in total or live discharge from the hospital, whichever comes first.

Standard of care

Standard of care

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: DRUG

Standard of care

Interventions

Reparixin

Reparixin was administered via oral tablets 1200 mg TID for 7 days. In case of improvement, treatment can be prolonged at discretion of the investigator up to a maximum of 21 days of treatment in total or live discharge from the hospital, whichever comes first.

Intervention Type: DRUG

Standard of care

Standard of care

Intervention Type: DRUG

Other Intervention Names

Repertaxin L-lysine salt; Control

Eligibility Criteria

Inclusion Criteria

1. Age 18 to 90.

2. Confirmed COVID-19 diagnosis

3. At least one of the following: # Respiratory distress, RR ≥ 30 breaths/min without oxygen; # Partial arterial oxygen pressure (PaO2) / Fraction of inspiration O2 (FiO2) >100 <300mmHg

(1mmHg = 0.133kPa). 4. Chest imaging confirms lung involvement and inflammation. 5. Inflammatory status as documented by at least one of the following: Lactate dehydrogenase (LDH) > normal range, C-reactive protein (CRP) ≥ 100mg/L or IL-6 ≥ 40pg/mL, serum ferritin ≥ 900ng/mL, XDP >20mcg/mL.

Exclusion Criteria

1. Cannot obtain informed consent.

2. Severe hepatic dysfunction (Child Pugh score ≥ C, or AST> 5 times the upper limit); Severe renal dysfunction (estimated glomerular filtration rate ≤ 30mL / min / 1.73 m2) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.

3. Patients with hypersensitivity to ibuprofen or to more than one non steroidal anti-inflammatory drug or to more than one medication belonging to the class of sulfonamides (e.g. sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib; hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole, does not qualify for exclusion)

4. Severe, active bleeding such as hemoptysis, gastrointestinal bleeding, central nervous system bleeding, and nosebleeds within 1 month before enrollment.

5. Pregnant and lactating women and those planning to get pregnant.

6. Participated in other interventional clinical trials with investigational medicinal products, not considered suitable for this study by the researchers.

7. At the time of enrollment, patients not in a clinical condition compatible with the oral administration of the study drug.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dompé Farmaceutici S.p.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenzo Piemonti, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Raffaele

Alberto Zangrillo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Raffaele

Locations

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo

São Paulo, , Brazil

Ospedale San Paolo

Milan, Lombardy, Italy

Ospedale San Raffaele

Milan, Lombardy, Italy

Ospedale di Varese

Varese, Lombardy, Italy

Countries

Brazil; Italy

References

Landoni G, Piemonti L, Monforte AD, Grossi P, Zangrillo A, Bucci E, Allegretti M, Goisis G, Gavioli EM, Patel N, De Pizzol M, Pasedis G, Mantelli F. A Multicenter Phase 2 Randomized Controlled Study on the Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients with COVID-19 Pneumonia. Infect Dis Ther. 2022 Aug;11(4):1559-1574. doi: 10.1007/s40121-022-00644-6. Epub 2022 May 26.

Reference Type: DERIVED

PMID: 35618953 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-001645-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

REPAVID-19

Identifier Type: -

Identifier Source: org_study_id