What side effects are associated with this type of intervention?

Common treatments for pneumonia include antibiotics such as macrolides, fluoroquinolones, and beta-lactams. The side effects of these antibiotics can vary but often include gastrointestinal symptoms (nausea, vomiting, diarrhea), allergic reactions, and, in some cases, more severe effects like tendonitis or QT prolongation with fluoroquinolones. For treatments similar to Reparixin, which is a CXCR1/2 inhibitor, specific side effects are not well-documented in the context of pneumonia. However, general side effects of CXCR1/2 inhibitors may include gastrointestinal disturbances, potential liver enzyme alterations, and possible effects on white blood cell counts. It is important to consult with a healthcare provider to understand the specific risks and benefits of any treatment.

What prior FDA approvals exist?

The FDA has approved several antibiotics for the treatment of pneumonia, including beta-lactams like penicillin, cephalosporins, macrolides such as azithromycin, and fluoroquinolones like moxifloxacin. These drugs target bacterial infections, which are a common cause of pneumonia. While specific CXCR1/2 inhibitors like Reparixin are being studied for their potential in treating pneumonia by limiting disease progression and inflammation, there are no current FDA approvals for CXCR1/2 inhibitors specifically for pneumonia treatment. The focus remains on antibiotics and supportive care.

What other types of research exist?

Promising novel alternatives to Reparixin for pneumonia patients include monoclonal antibodies like LY-CoV555 and the REGEN-COV antibody combination, which have shown efficacy in treating COVID-19-related pneumonia. Additionally, inhaled corticosteroids such as budesonide and ciclesonide have demonstrated potential in early COVID-19 treatment, which could be beneficial for pneumonia patients. These alternatives have been evaluated in clinical trials and have shown positive outcomes in terms of reducing disease severity and improving recovery.

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Reparixin for COVID-19

Phase 3

Waitlist Available

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 3, 7±1, 14±2, 21±2, 28 ±2 or at hospital discharge

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

Nasal congestion

Epistaxis

Intra-abdominal haemmorrhage

Peritoneal haemorrhage

Stomatitis

Portal vein presssure increased

Back pain

Alloimmunisation

Pruritus

Hypotension

Tachycardia

Aspartate aminotransferase increased

Insomnia

Abdominal pain upper

Multiple organ dysfunction syndrome

Rhinorrhoea

Urinary tract infection

Generalised oedema

Acute psychosis

Haemorrhage

Lip swelling

Catheter site haemorrhage

Chest discomfort

Chills

Fatigue

Vessel puncture site erythema

Hepatic haemorrhage

Coccidioidomycosis

Fall

Head injury

Incision site pain

C-reactive protein increased

Decreased appetite

Fluid retention

Arthralgia

joint swelling

Neck pain

Pain in extremity

Dysgeusia

Migrane

Implant site haemorrhage

Oedema peripheral

Lip oedema

Acne

Leukopenia

Neutropenia

Erythema

Hyperhidrosis

Hot flush

Transplant rejection

Sepsis

Cervical vertebral fracture

Complications of transplant surgery

Upper limb fracture

HLA marker study positive

Hepatic enzyme increased

Hypoglycemia

Adenocarcinoma

Diabetic neuropathy

Generalised tonic-clonic seizure

Angina pectoris

Bradycardia

Peripheral swelling

Syncope

Tremor

Anxiety

Upper-airway cough syndrome

100%

80%

60%

40%

20%

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

0 / 7Eligibility criteria met

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.