COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05413642

Giuseppe Remuzzi, MD

giuseppe.remuzzi@marionegri.it

2022-06-10

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

inclusion criteria: male and female adult (≥18 years old) subjects with early mild/moderate symptoms of covid-19*, who start the treatment without waiting results of a nasopharyngeal swab** * influenza-like syndrome, (i.e. flu, cough, myalgias/arthralgias or other painful symptoms, fever, gastrointestinal symptoms), no dyspnea, spo2 >94%, or asthenia,ageusia/dysgeusia, anosmia, or mews 0 to 3. ** nasopharyngeal swab should be performed soon after the onset of symptoms possibly related to sars-cov-2 subjects without known comorbidities in their previous medical history subjects with known comorbidities that bring them at high risk of covid-19 progression (heart disease, hypertension, asthma or lung disease, diabetes, chronic kidney disease, stroke or neurological problems, weakened immune system - e.g. receiving chemotherapy -, and self-reported obesity or body-mass index of at least 30 kg/sqm) informed consent

subjects who require immediate hospital admission because of severe covid-19 symptoms at onset according to family doctor's assessment (mews score 5, and/or septic shock, multiorgan failure) known hypersensitivity or allergy to any medication under investigation specific contraindications to the use of each recommended drugs according to their summary of product characteristics and the clinical judgment of family doctor legal incapacity, limited legal incapacity, intellectual disability, uncooperative attitude or any other evidence that the patient will not be able to understand the study aims and procedures pregnancy* (*patient with childbearing potential will be included according to the pragmatic design of the study)

2

Mario Negri Institute for Pharmacological Research

18

100

None

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

1564

proportion of patients who reach score ≥ 5 of MEWS, an index of the need of hospitalization, in the two treatment groups

None

Phase 3

[{"arm_notes": "", "treatment_id": 2531, "treatment_name": "Recommended treatment schedule", "treatment_type": "Non-pharmocologic agent", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]