Reparixin in COVID-19 Pneumonia - Efficacy and Safety

NCT04794803 | Terminated Phase 2 Results DMC

• 2 other identifiers: REPAVID-192020-001645-40
• Study Type: interventional
• Target: 56
• Locations: 2 countries
• Sites: 4

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

Conditions

Severe Pneumonia

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• Phase 2 - Percentage of Participants With Composite Endpoint of Clinical Events

  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

  Up to Day 1

Secondary Outcomes (18)

• Phase 2 - Percentage of Patients With Improvement in Clinical Severity Score (as Recommended by WHO for COVID Studies) of at Least Two Points

  At day 1, day 2, week 1, day 21(end of treatment, EOT), EOS (end of study, i.e. 7±3 days after EOT)

• Phase 2 - Percentage of Improved Subjects in Dyspnea Severity, Assessed by Liker Scale

  Baseline, day 1, day 2, week 1, day 21(end of treatment, EOT), 7±3 days after treatment period (end of study, EOS)

• Phase 2 - Change From Baseline in Dyspnea Severity, Assessed by VAS Scale

  Baseline, day 1, day 2, week 1, day 21(end of treatment, EOT), 7±3 days after treatment period (end of study, EOS)

• Changes From Baseline in Body Temperature to Any Post-baseline Timepoints

  Baseline, Day 1, Day 2, Week 1, EOT and EOS

• Phase 2 - Percentage of Subjects Worsened, During Supplemental Oxygen Treatment, From Randomization According to PaO2/FiO2

  At day 1, day 2, week 1, day 21(end of treatment), follow-up (FU) (7±3 days after treatment period)

Study Arms (2)

Reparixin

EXPERIMENTAL

Reparixin oral tablets 1200 mg TID for 7 days

Drug: Reparixin

Standard of care

ACTIVE COMPARATOR

Standard of care

Drug: Standard of care

Interventions

Reparixin 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.

Also known as: Repertaxin L-lysine salt

Reparixin

Standard of care DRUG

Standard of care

Also known as: Control

Standard of care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 90.
• Confirmed COVID-19 diagnosis
• 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.

You may not qualify if:

• Cannot obtain informed consent.
• 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.
• Severe, active bleeding such as hemoptysis, gastrointestinal bleeding, central nervous system bleeding, and nosebleeds within 1 month before enrollment.
• Pregnant and lactating women and those planning to get pregnant.
• Participated in other interventional clinical trials with investigational medicinal products, not considered suitable for this study by the researchers.
• At the time of enrollment, patients not in a clinical condition compatible with the oral administration of the study drug.

Sponsors & Collaborators

• Dompé Farmaceutici S.p.A: lead

Study Sites (4)

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

São Paulo, 05403-900, Brazil

Location

Ospedale San Paolo

Milan, Lombardy, 20100, Italy

Location

Ospedale San Raffaele

Milan, Lombardy, 20100, Italy

Location

Ospedale di Varese

Varese, Lombardy, Italy

Location

Related Publications (1)

• 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.

  PMID: 35618953 DERIVED

MeSH Terms

Conditions

Pneumonia; COVID-19

Interventions

reparixin; Standard of Care

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr Maria De Pizzol, BSc
• Organization: Dompé Farmaceutici

clinops@pec.dompe.it

+39 02 583831

Study Officials

• Lorenzo Piemonti, MD PhD

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

• Alberto Zangrillo, MD PhD

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 12, 2021
• Study Start: May 5, 2020
• Primary Completion: November 27, 2020
• Study Completion: February 2, 2021
• Last Updated: January 8, 2024
• Results First Posted: March 17, 2022

Record last verified: 2022-05

Locations

IT (3); BR (1)