COVID-19 trials registries data warehouse

http://en.irct.ir/trial/48702

Amir Hossein Karagah

Info@persisgen.com

2020-06-13

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

Age of 18 years or more Elevated C-reactive protein levels Fever or cough or dyspnea SpO2 of 93% or less Confirmed SARS-CoV-2 infection by rt-PCR or radiology PaO2/FiO2 of 300 or less Ability to understand and desire to sign a form of informed consent to participate in the study

Positive PPD test Active Hepatitis B or C infection, Positive HBV antigen or HCV antigen or HIV infection Thrombocytopenia ( platelet count of 150000 per micL) Leukopenia ( white blood cells of 3.6*10^9) Anemia (hemoglobin of 7.5 g/dL) Elevated liver transaminases of 2 fold or more Active infection based on cultures (not received intravenous antibiotics in previous 8 weeks or oral antibiotics in previous 2 weeks) history of malignancy in previous 5 years based on pathology and radiological data history of anakinra, canakinumab or any interleukin-1 inhibitors administration History of receiving of attenuated vaccine in last 2 weeks or during the study hypersensitivity to any component of the medication

2

Persisgen Par Pharmaceutical Company

18

100

Iran

Severe disease at enrollment

6: Severe disease at enrollment

30

No need for hospitalization Hospitalization without need for oxygenation therapy Hospitalization with oxygen therapy Hospitalization with receiving non-invasive ventilation or high flow oxygen cannula Hospitalization with receiving mechanical ventilation or extra-corporeal membrane oxygenation Death

Phase 3

[{"arm_notes": "", "treatment_id": 83, "treatment_name": "Anakinra", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]