COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04352400

Gian Paolo Rossi, Prof.

gianpaolo.rossi@unipd.it

2020-04-20

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - hospitalized, covid-19 positive, between 18 and ≤ 85 years of age; - signed inform consent form; - body temperature > 37.3 ℃; - oxygenation criterion (any of the following): i) oxygen saturation ≤94% on room air; ii) pao2/fio2 ratio ≤300 mmhg but > 100 mmhg, if patient on supplemental oxygen; iii) spo2/fio2<200 if no arterial blood gas available; - respiratory rate (rr) ≥ 25 beats/min.

- pregnant or lactating females; - unwillingness or inability to complete the study. - rapidly deteriorating clinical condition or low likelihood to complete the study according to the investigator; - egfr < 30 ml/min/m2 assessed with ckd epi formula; - current or chronic history of liver disease (child pugh score ≥ 10), or known hepatic or biliary abnormalities; - participation in a clinical trial with an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer); - patients requiring high doses of loop diuretics (i.e. > 240 mg furosemide daily) with significant intravascular volume depletion, as assessed clinically; - history of allergy; - history of sensitivity to heparin or heparin-induced thrombocytopenia; - unstable hemodynamics in the preceding 4 hours (sbp < 90 mmhg, and/or vasoactive agents required); - hemoglobin < 7 at time of drug infusion. transfusion is allowed to increase hemoglobin levels before entry into the study; - malignancy or any other condition for which estimated 6-month mortality >50%; - arterial blood ph less than 7.2; - known evidence of chronic interstitial infiltration at imaging; - known hospitalization within the past six months for respiratory failure (paco2 > 50 mmhg or pao2 < 55 mmhg, or oxygen saturation <88% on fio2 = 0.21); - known chronic vascular disease resulting in severe exercise restriction (i.e. unable to perform household duties); - known secondary polycythemia, severe pulmonary hypertension, or ventilator dependency; - known vasculitis with diffuse alveolar hemorrhage;. - pre-existing renal failure on hemodialysis or peritoneal dialysis requiring renal replacement therapy; - extracorporeal membrane oxygenation (ecmo); - immunosuppressive treatment; - patient in trials for covid-19 within 30 days before; - unstable hemodynamics in the preceding 4 hours (map ≤ 65 mmhg, or sap < 90 mmhg, dap < 60 mmhg, and vasoactive agents required); - hyperkalemia , i.e. serum k+ levels > 5.0 meq/l; - severe active bleeding; - any other uncontrolled comorbidities that increase the risks associated with the study drug administration, as assessed by the medical expert team.

2

University Hospital Padova

18

85

Italy

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

256

Time-to-clinical improvement

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 854, "treatment_name": "Nafamostat mesilate", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]