Reparixin add-on Therapy to Standard Care to Limit Progression in Pts With COVID19 & Other Commun… (NCT05254990) | Clinical Trial Compass
TerminatedPhase 3
Reparixin add-on Therapy to Standard Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia
Stopped: The study was stopped due to futility as per protocol
United States, Argentina, Australia414 participantsStarted 2022-04-27
Plain-language summary
Primary objective:
\- To compare the efficacy of reparixin vs. placebo in the proportion of patients dead or requiring IMV (or ECMO) by Day 28.
Key secondary objectives:
* To compare the efficacy of reparixin vs placebo in all-cause mortality at day 180.
* To compare the efficacy of reparixin vs placebo in proportion of patients alive and discharged at day 28
* To compare the efficacy of reparixin vs placebo in ventilatory-free days at day 28.
* To compare the efficacy of reparixin vs placebo in proportion of patients with IMV (or ECMO) by day 28.
* To compare the efficacy of reparixin vs placebo in length of primary hospital stay.
Other efficacy objectives
\- To compare the efficacy of reparixin vs placebo on several disease severity/progression measures including recovery, ventilatory free days and mortality.
Safety objectives:
\- To evaluate safety and tolerability of oral reparixin versus placebo in the specific clinical setting.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Informed consent signed
. Male and female ≥18 years old;
. Patients hospitalized for clinically suspected CAP, defined as the occurrence of (within 48h from hospital admission):
. at least 1 of the following signs/symptoms: dyspnea, cough, purulent sputum, crackles (rales) and/or rhonchi
. body temperature \> 38°C or \<36°C (before or during admission) or leucocytosis (\> local ULN)
. new/increased pulmonary infiltrate(s) by chest imaging
. Need for non-invasive supplemental oxygen (NIAID-OS 5-6);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Patients Dead or Requiring Invasive Mechanical Ventilation (IMV) or Extracorporeal Membrane Oxygenation (ECMO) by Day 28 [NIAID-OS 7].
. SpO2 \<92% at room air, or PaO2/FiO2 (or SpO2/FiO2) \<300;
Exclusion criteria
. Treatment with IMV or ECMO (NIAID-OS 7);
. Hepatic dysfunction: ALT or AST \> 5 ULN; history of chronic hepatic disease (defined with Child-Pugh score B or C);
. Renal dysfunction: estimated glomerular filtration rate (eGFR, MDRD) \<50 mL/min/1.73 m2, or need for haemodialysis or hemofiltration;
. Current use of \>2 immunosuppressive medications or immunosuppression status (AIDS, aplastic anaemia, asplenia, systemic chemotherapy within the past 3 months, neutropenia (ANC \< local LLN), solid organ or bone marrow transplant recipients)
. Treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period;
. Anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening
. History of:
. intolerance or hypersensitivity to ibuprofen to more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib (hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole does not qualify for exclusion)