COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04322565

Umberto Maggiore

Not reported

2020-03-26

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - positive nasopharyngeal swab for covid-19, asymptomatic or paucisymptomatic, aged ≥70 years and/or with clinical risk factors for poor outcome (clinically relevant chronic lung disease, diabetes and/or heart disease) or - symptomatic with respiratory or systemic symptoms, however clinically stable (mews<3) with ct imaging showing viral pneumonia and positive or pending pharyngo-nasal swab for covid-19: temperature 38°c and/or intensive cough, respiratory rate < 25 /min, oxygen saturation (pulse oximetry) >95% - positive swab for covid-19 - with respiratory and/or systemic symptoms and initial mild respiratory failure e with objective signs of lung involvement; the patient is in stable conditions (mews < 3) temperature>38°c and or intensive cough, respiratory rate ≥25 /min, or oxygen saturation 94- 95% in room air

- pregnant or breast feeding - mews >=3 - hepatic failure child-pugh c - enrollment in other pharmacological studies - ongoing treatment with colchicine - ongoing treatment with antiviral drugs that include ritonavir or cobicistat - any medical condition or disease which in the opinion of the investigator may place the patient at unacceptable risk for study participation.

2

Azienda Ospedaliero-Universitaria di Parma

18

None

Italy

Severe disease at enrollment

6: Severe disease at enrollment

193

Hospital discharge;Clinical improvement

None

Phase 2

[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]