Status:
TERMINATED
Reparixin in COVID-19 Pneumonia - Efficacy and Safety
Lead Sponsor:
Dompé Farmaceutici S.p.A
Conditions:
Severe Pneumonia
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
PHASE3
Brief Summary
* Phase 2 Study Objectives: efficacy and safety of of Reparixin treatment as compared to the control arm in adult patients with severe COVID-19 pneumonia * Phase 3 Study Objectives: efficacy and safet...
Detailed Description
This clinical trial is an adaptive phase 2/3, randomized, controlled multicenter study on the efficacy and safety of Reparixin in the treatment of hospitalized patients with COVID-19 pneumonia. 48 pat...
Eligibility Criteria
Inclusion
- Phase 2
- Age 18 to 90.
- Confirmed COVID-19 diagnosis
- At least one of the following: # Respiratory distress, RR ≥ 30 breaths/min without oxygen; # Partial arterial oxygen pressure (PaO2) / Fraction of inspiration O2 (FiO2) \>100 \<300mmHg
- (1mmHg = 0.133kPa). 4. Chest imaging confirms lung involvement and inflammation. 5. Inflammatory status as documented by at least one of the following: Lactate dehydrogenase (LDH) \> normal range, C-reactive protein (CRP) ≥ 100mg/L or IL-6 ≥ 40pg/mL, serum ferritin ≥ 900ng/mL, XDP \>20mcg/mL.
- Phase 3 Same as above; other criteria TBD based on Phase 2 outcomes.
Exclusion
- • Phase 2/3
Key Trial Info
Start Date :
May 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04794803
Start Date
May 5 2020
End Date
February 2 2021
Last Update
January 8 2024
Active Locations (4)
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1
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo
São Paulo, Brazil, 05403-900
2
Ospedale San Paolo
Milan, Lombardy, Italy, 20100
3
Ospedale San Raffaele
Milan, Lombardy, Italy, 20100
4
Ospedale di Varese
Varese, Lombardy, Italy