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 States414 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 range18 Years
SexALL
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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);
✓. 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);
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].
✕. 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)