COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001645-40/IT

Dompé farmaceutici S.p.A. - Flavio Mantelli

flavio.mantelli@dompe.com

2020-09-22

Terminated

RCT

Randomized

Adaptive

Open label

multi-center

Treatment

- Phase 2 Inclusion Criteria: 1. Age 18 to 90. 2. Confirmed COVID-19 diagnosis 3. At least one of the following: 1. Respiratory distress, RR => 30 breaths/min without oxygen, 2. 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 Inclusion Criteria: Same as above, other criteria TBD based on Phase 2 outcomes. - Phase 2 Inclusion Criteria: 1. Age 18 to 90. 2. Confirmed COVID-19 diagnosis 3. At least one of the following: 1. Respiratory distress, RR => 30 breaths/min without oxygen, 2. 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 Inclusion Criteria: Same as above, other criteria TBD based on Phase 2 outcomes.

- Phase 2/3 Exclusion Criteria: 1. Cannot obtain informed consent. 2. Severe hepatic dysfunction (Child Pugh score => C, or AST> 5 times the upper limit), Severe renal dysfunction (estimated glomerular filtration rate <= 30mL / min / 1.73 m2) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis. 3. Patients with hypersensitivity to ibuprofen or to more than one non steroidal anti-inflammatory drug or to more than one medication belonging to the class of sulfonamides (e.g. sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib, hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole, does not qualify for exclusion) 4. Severe, active bleeding such as hemoptysis, gastrointestinal bleeding, central nervous system bleeding, and nosebleeds within 1 month before enrollment. 5. Pregnant and lactating women and those planning to get pregnant. 6. Participated in other interventional clinical trials with investigational medicinal products, not considered suitable for this study by the researchers. 7. At the time of enrollment, patients not in a clinical condition compatible with the oral administration of the study drug. - Phase 2/3 Exclusion Criteria: 1. Cannot obtain informed consent. 2. Severe hepatic dysfunction (Child Pugh score => C, or AST> 5 times the upper limit), Severe renal dysfunction (estimated glomerular filtration rate <= 30mL / min / 1.73 m2) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis. 3. Patients with hypersensitivity to ibuprofen or to more than one non steroidal anti-inflammatory drug or to more than one medication belonging to the class of sulfonamides (e.g. sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib, hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole, does not qualify for exclusion) 4. Severe, active bleeding such as hemoptysis, gastrointestinal bleeding, central nervous system bleeding, and nosebleeds within 1 month before enrollment. 5. Pregnant and lactating women and those planning to get pregnant. 6. Participated in other interventional clinical trials with investigational medicinal products, not considered suitable for this study by the researchers. 7. At the time of enrollment, patients not in a clinical condition compatible with the oral administration of the study drug.

2

DOMPé FARMACEUTICI S.P.A.

18

90

Italy

Severe disease at enrollment

6: Severe disease at enrollment

159

- Phase 2 Primary Endpoint: Composite endpoint of clinical events (the patient requires at least one of the following: supplemental oxygen requirement, mechanical ventilation use, admission to Intensive Care Unit (ICU), and use of a rescue medication for any reason) - Phase 3 Primary Endpoint: Composite endpoint of death and of severe clinical events (the patient dies or requires mechanical ventilation use and/or admission to ICU) - Phase 2 Primary Endpoint: Composite endpoint of clinical events (the patient requires at least one of the following: supplemental oxygen requirement, mechanical ventilation use, admission to Intensive Care Unit (ICU), and use of a rescue medication for any reason) - Phase 3 Primary Endpoint: Composite endpoint of death and of severe clinical events (the patient dies or requires mechanical ventilation use and/or admission to ICU)

nan

Phase 2/Phase 3

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