Status:
COMPLETED
Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia.
Lead Sponsor:
Dompé Farmaceutici S.p.A
Conditions:
Pneumonia, Viral
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
The study objective is to assess Efficacy and safety of Reparixin treatment as compared to placebo (both on top of standard treatment) in adult patients with severe COVID-19 pneumonia.
Detailed Description
This is a phase 3 clinical trial designed as a randomized, double-blind, placebo-controlled, multicentre study to evaluate the efficacy and safety of Reparixin in hospitalized adult patients with seve...
Eligibility Criteria
Inclusion
- Age 18 to 90, male and female subject of any race
- Reverse transcriptase Polymerase Chain Reaction (rt-PCR)-confirmed COVID-19 infection based on a nasal / oropharyngeal swab within 10 days before randomization
- At least one of the following: 1) Respiratory distress with tachypnea (RR ≥ 24 breaths/min without oxygen); 2) Partial arterial oxygen pressure (PaO2) / Fraction of inspiration O2 (FiO2), P/F \>100 and \<300 mmHg (1mmHg = 0.133kPa), 3) SpO2 ≤ 94% while breathing ambient air.
- Calculation through validated Sat/FiO2 scales is allowed. P/F value of reference if the last available before the signature of consent.
- Need of supplemental oxygen (i.e. new use of supplemental oxygen, or increased oxygen requirement if on chronic oxygen) requiring low- or high-flow oxygen or non-invasive mechanical ventilation (7-point WHO-OS category 4 or 5).
- Radiological chest imaging (X-rays, CT scan) confirms lung involvement and inflammation.
Exclusion
- Cannot obtain informed consent.
- Hepatic dysfunction with Child Pugh score B or C, or ALT or AST\> 5 times the upper limit.
- Renal dysfunction with estimated glomerular filtration rate (MDRD) \< 50 mL/min/1.73 m2 or patient receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
- Bacterial sepsis (besides COVID-19 sepsis).
- Known congenital or acquired immune deficiency.
- 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.
Key Trial Info
Start Date :
February 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT04878055
Start Date
February 14 2021
End Date
October 31 2021
Last Update
June 13 2024
Active Locations (17)
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1
The George Washington University Medical Faculty Associates, 2150 Pennsylvania Avenue NW
Washington D.C., District of Columbia, United States, 20037
2
Franciscan Alliance, 421 N Emerson Ave,
Greenwood, Indiana, United States, 46143
3
Policlinico S. Orsola Malpighi UO di Pneumologia e Terapia Int. Respiratoria
Bologna, Italy, 40138
4
Ospedale Policlinico San Martino Malattie infettive e tropicali
Genova, Italy, 16132