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Reparixin for COVID-19

Phase 3
Recruiting
Led By Giovanni Landoni, MD
Research Sponsored by Dompé Farmaceutici S.p.A
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Need for non-invasive supplemental oxygen (NIAID-OS 5-6; Appendix 14.4.1)
Be older than 18 years old
Must not have
Hepatic dysfunction: ALT or AST > 5 ULN; history of chronic hepatic disease (defined with Child-Pugh score B or C)
Treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period (see section 5.5.2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 3, 7±1, 14±2, 21±2, 28 ±2 or at hospital discharge
Awards & highlights
Pivotal Trial

Summary

This trial is testing a medication called reparixin, taken by mouth, to see if it can help adults hospitalized with severe lung infections like pneumonia and COVID-19. The goal is to see if reparixin can reduce inflammation and stop the disease from getting worse. Patients will receive reparixin along with their usual care. Reparixin has been tested in various critical settings and shown potential in improving survival in patients at high risk for in-hospital mortality.

Who is the study for?
Adults hospitalized with infectious pneumonia, including COVID-19, needing oxygen but not severe interventions like mechanical ventilation. Women must avoid pregnancy during and shortly after the trial or be post-menopausal; men agree to use condoms. Excludes those with certain drug allergies, gastrointestinal issues from NSAIDs, significant liver/renal dysfunction, on multiple immunosuppressants, or in other trials.
What is being tested?
The trial is testing if reparixin can help limit disease progression when added to standard care for adults with community-acquired pneumonia (CAP), including COVID-19. It will compare recovery rates and mortality between patients taking reparixin orally and those receiving a placebo.
What are the potential side effects?
Potential side effects of reparixin may include reactions similar to NSAID intolerance such as digestive issues since it's related to that drug class. Specific side effects are being studied as part of the trial's safety objectives.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need extra oxygen to breathe properly.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver isn't working well (high enzyme levels or severe chronic disease).
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I am not taking any medication that I cannot stop during the trial.
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I have been in the hospital for more than 72 hours.
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My kidney function is low or I need dialysis.
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I am receiving or have received IMV or ECMO treatment.
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I have a severe lung infection or related serious lung condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 3, 7±1, 14±2, 21±2, 28 ±2 or at hospital discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 3, 7±1, 14±2, 21±2, 28 ±2 or at hospital discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Extracorporeal Membrane Oxygenation
Secondary study objectives
Change in quality of life using EuroQol-5-dimensions-5 levels (EQ-5D-5L) questionnaire
Clinical failure by day 3 and day 7
Proportion of patients recovered
+2 more

Side effects data

From 2017 Phase 3 trial • 51 Patients • NCT01817959
45%
Nausea
28%
Headache
24%
Vomiting
24%
Abdominal pain
24%
Diarrhoea
21%
Hypoglycaemia
21%
Anaemia
14%
Malaise
10%
Blood creatinine increased
10%
Catheter site pain
10%
Procedural pain
10%
Hyperkalaemia
10%
Musculoskeletal pain
10%
Constipation
10%
Hypertension
10%
Pyrexia
7%
Nasal congestion
7%
Epistaxis
7%
Intra-abdominal haemmorrhage
7%
Peritoneal haemorrhage
7%
Stomatitis
7%
Portal vein presssure increased
7%
Back pain
7%
Alloimmunisation
7%
Pruritus
7%
Hypotension
7%
Tachycardia
3%
Aspartate aminotransferase increased
3%
Insomnia
3%
Abdominal pain upper
3%
Multiple organ dysfunction syndrome
3%
Rhinorrhoea
3%
Urinary tract infection
3%
Generalised oedema
3%
Acute psychosis
3%
Haemorrhage
3%
Lip swelling
3%
Catheter site haemorrhage
3%
Chest discomfort
3%
Chills
3%
Fatigue
3%
Vessel puncture site erythema
3%
Hepatic haemorrhage
3%
Coccidioidomycosis
3%
Fall
3%
Head injury
3%
Incision site pain
3%
C-reactive protein increased
3%
Decreased appetite
3%
Fluid retention
3%
Arthralgia
3%
joint swelling
3%
Neck pain
3%
Pain in extremity
3%
Dysgeusia
3%
Migrane
3%
Implant site haemorrhage
3%
Oedema peripheral
3%
Lip oedema
3%
Acne
3%
Leukopenia
3%
Neutropenia
3%
Erythema
3%
Hyperhidrosis
3%
Hot flush
3%
Transplant rejection
3%
Sepsis
3%
Cervical vertebral fracture
3%
Complications of transplant surgery
3%
Upper limb fracture
3%
HLA marker study positive
3%
Hepatic enzyme increased
3%
Hypoglycemia
3%
Adenocarcinoma
3%
Diabetic neuropathy
3%
Generalised tonic-clonic seizure
3%
Angina pectoris
3%
Bradycardia
3%
Peripheral swelling
3%
Syncope
3%
Tremor
3%
Anxiety
3%
Upper-airway cough syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Reparixin Group
Placebo Group

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Reparixin + standard of careExperimental Treatment1 Intervention
Reparixin will be administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses will be administered maintaining an interval between doses of about 8 hours.
Group II: Placebo + standard of carePlacebo Group1 Intervention
Placebo tablets are identical in appearance to the active formulation. Placebo will be administered with the same treatment schedule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lysine
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pneumonia primarily include antibiotics, which target and kill the bacteria causing the infection. For example, beta-lactam antibiotics like penicillin disrupt bacterial cell wall synthesis, leading to cell death. Macrolides, such as azithromycin, inhibit protein synthesis by binding to bacterial ribosomes. These mechanisms are crucial as they directly eliminate the pathogens responsible for the infection, thereby reducing symptoms and preventing complications. Reparixin, a CXCR1/2 inhibitor, works differently by blocking the receptors involved in the inflammatory response, potentially reducing lung inflammation and damage. This is significant for pneumonia patients as it may help limit disease progression and improve recovery outcomes.

Find a Location

Who is running the clinical trial?

Dompé Farmaceutici S.p.ALead Sponsor
51 Previous Clinical Trials
4,169 Total Patients Enrolled
2 Trials studying Pneumonia
343 Patients Enrolled for Pneumonia
Enrico Maria Minnella, MDStudy DirectorDompé Farmaceutici
1 Previous Clinical Trials
Enrico Minnella, MDStudy DirectorDompé Farmaceutici
3 Previous Clinical Trials
393 Total Patients Enrolled

Media Library

Reparixin + standard of care Clinical Trial Eligibility Overview. Trial Name: NCT05254990 — Phase 3
Pneumonia Research Study Groups: Reparixin + standard of care, Placebo + standard of care
Pneumonia Clinical Trial 2023: Reparixin + standard of care Highlights & Side Effects. Trial Name: NCT05254990 — Phase 3
Reparixin + standard of care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05254990 — Phase 3
~150 spots leftby Oct 2025
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