COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04331600

Marta Duda-Sikula, MBA

marta.duda-sikula@umed.wroc.pl

2020-04-02

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria age >=60 years or age 18-59 years with one of the following conditions: chronic lung disease chronic cardiovascular disease diabetes malignancy diagnosed within 5 years prior to enrollment history of chronic kidney disease atrial fibrillation past haemorrhagic stroke, ischemic stroke or transient cns ischemia obesity defined as bmi ≥ 30 kg / m2 10-year risk of fatal cardiovascular disease sars-cov-2 infection confirmed in rt-pcr (nasopharyngeal swab) hospitalization not required based on clinical judgement ability to participate in telemedical care exclusion criteria lack of written informed consent possible failure to comply with the protocol chloroquine, hydroxychloroquine therapy within 30 days prior to enrollment antiviral therapy within 14 days prior to enrollment contraindications to chloroquine (pregnancy, breast-feeding, severe renal insufficiency, amiodarone therapy, alcohol disease, haematological disorders, epilepsia, porphyria, liver disease/cirrhosis, retinopathy, fainting/syncope, myasthenia) hypersensitivity to chloroquine or drug excipients hiv infection other relevant circumstances/conditions based on clinical judgement concurrent participation in another interventional clinical trial

None

2

Wroclaw Medical University

18

None

Poland

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

16

COVID-19-related hospitalization or all-cause death

None

Phase 4

[{"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]