Reparixin add-on Therapy to Std Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia

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Dompé

Status and phase

Enrolling
Phase 3

Conditions

Infectious Pneumonia
Severe COVID-19

Treatments

Other: Placebo
Drug: Reparixin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05254990
REP0321
2021-006951-32 (EudraCT Number)

Details and patient eligibility

About

Primary objective: - To evaluate the efficacy of oral reparixin versus standard care alone in limiting disease progression in adult patients hospitalised for infectious pneumonia acquired in the community (CAP), including COVID-19. Secondary objectives: - To determine the effect of reparixin on several disease severity/progression measures including recovery, ventilatory free days and mortality. Safety objectives: - To evaluate the safety of oral reparixin versus placebo in the specific clinical setting.

Full description

Multinational, multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase III trial. It will enrol 526 male and female patients >18 years, hospitalised for CAP (including COVID-19), assigned (1:1) to receive either oral reparixin (treatment group) or matched placebo (control group) three times a day (TID) for up to 21 days. Randomisation will be stratified according to disease severity and site. All the patients will receive the standard of care based on their clinical need, including COVID-19 and CAP medications, as per local standard therapy at the trial site and in line with international guidelines. The primary outcome will be evaluated at day 28, secondary will be evaluated from day 3 to day 180. An independent external data monitoring committee (DMC) will oversee the study and evaluate unblinded interim data for efficacy, futility, and safety.

Enrollment

526 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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; Appendix 14.4.1);
  • SpO2 <92% at room air, or PaO2/FiO2 (or SpO2/FiO2) <300;

Females of child-bearing potential and with an active sexual life must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception:

  • Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after the last IMP dose
  • A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit until 30 days after the last IMP dose
  • A male sexual partner who agrees to use a male condom with spermicide
  • A sterile sexual partner

Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, with child-bearing potential, pregnancy test result must be negative before first drug intake.

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 (see section 5.5.2);
  • 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)
  • lactase deficiency, galactosemia or glucose-galactose malabsorption
  • gastrointestinal bleeding or perforation due to previous NSAIDs therapy or recurrent peptic ulcer/haemorrhage
  • allergy to reparixin or any component of the IMP formulation
  • Active bleeding or bleeding diathesis (excluding menses), prior intracranial haemorrhage
  • Participation in other interventional clinical trials
  • Clinical condition not compatible with oral administration of the study drug

Pregnancy:

  • positive or missing pregnancy test before first drug intake or day 1;
  • pregnant or lactating women;
  • women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study
  • Current hospital stay >72h
  • Complicated CAP-associated conditions, such as fungal pulmonary infection, tuberculosis infection, abscess, empyema, significant bilateral pleural effusion, massive pulmonary embolism

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

526 participants in 2 patient groups, including a placebo group

Reparixin + standard of care
Experimental group
Description:
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.
Treatment:
Drug: Reparixin
Placebo + standard of care
Placebo Comparator group
Description:
Placebo tablets are identical in appearance to the active formulation. Placebo will be administered with the same treatment schedule.
Treatment:
Other: Placebo

Trial contacts and locations

109

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Central trial contact

Sophie Toya, MD; Enrico Minnella, MD

Data sourced from clinicaltrials.gov

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