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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 3, 7±1, 14±2, 21±2, 28 ±2 or at hospital discharge
Awards & highlights

Study Summary

This trialwill look at how a new drug, reparixin, affects adult patients with infectious pneumonia, including COVID-19, to see if it helps prevent disease progression and improve safety.

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.Check my eligibility
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.See study design
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
Select...
I need extra oxygen to breathe properly.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Extracorporeal Membrane Oxygenation
Secondary outcome measures
28-day ICU-free days
All-cause mortality
All-cause mortality at day 180
+20 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%
Epistaxis
7%
Nasal congestion
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%
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%
Abdominal pain upper
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

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

Find a Location

Who is running the clinical trial?

Dompé Farmaceutici S.p.ALead Sponsor
49 Previous Clinical Trials
4,008 Total Patients Enrolled
2 Trials studying Pneumonia
368 Patients Enrolled for Pneumonia
Enrico Maria Minnella, MDStudy DirectorDompé Farmaceutici
1 Previous Clinical Trials
Enrico Minnella, MDStudy DirectorDompé Farmaceutici
2 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When Reparixin is used in combination with regular medical treatments, are patients at a higher risk for negative side effects?

"There is evidence from past studies to support Reparixin's efficacy, as well as data backing its safety. Thus, we have given it a 3 on our scale."

Answered by AI

Are there any sites in North America conducting this clinical trial?

"There are 23 locations currently running this trial, for example Covenant Healthcare in Saginaw, Augusta University Health - Augusta University Medical Center in Augusta, and Newton-Wellesley Hospital in Newton."

Answered by AI

Who else is applying?

What site did they apply to?
Baptist Hospitals of Southeast Texas
MD Banner University Medical Center /Arizona University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

All for the good of health issues and learn so l can help someone else.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Reparixin add-on Therapy to Std Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia
2022. "Reparixin add-on Therapy to Std Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05254990.
All > Covid 19
~75 spots leftby Sep 2024
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