COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04390061

Armando Gabrielli, MD

a.gabrielli@staff.univpm.it

2020-05-15

Unknown

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - sars-cov2 infection diagnosed by rt-pcr - ct-scan confirmed interstitial pneumonia - hospital admission from less than 24h - p/f ratio >150 mmhg - written informed consent

- age <18 ys or >65 - patients in mechanical ventilation at time of admission - severe hearth failure (nyha 3 or 4) - qtc > 470 ms or >500 ms in wide qrs patients - severe history of chronic ischemic heart disease, defined as history of major adverse cardiovascular event and/or recent (one year) revascularization. - history of recurrent deep venous thrombosis and pulmonary embolism or established thrombophilic conditions (e.g. history of anti-phospholipid antibodies, …) - active bacterial or fungal infection - hematological cancer - metastatic or intractable cancer - pre-existent neurodegenerative disease - severe hepatic impairment, - history of acute diverticular disease or intestinal perforation - hbsag positive and/or hbv-dna positive patients - severe renal failure (creatinine clearance <30ml/h) - active herpes zoster infection - patients with active or latent tb - severe anemia (hb<9g/dl) - lymphocyte count below 750/mcl - neutrophil count below 1000/mcl - platelet count below 50000/mcl - pregnancy or lactation - history of intolerance to the experimental drugs or excipients - degenerative maculopathy or other relevant retinal disease - inability to give informed consent (severe transitory or permanent mental impairment, incapacitation)

2

Università Politecnica delle Marche

18

65

None

Moderate disease at enrollment

3: Moderate disease at enrollment

116

Prevention of severe Respiratory Failure requiring mechanical ventilation

None

Phase 2

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1579, "treatment_name": "Hydroxychloroquine+tofacitinib", "treatment_type": "Antimalarials+kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}]