COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001750-22/GB

Imperial College Healthcare NHS Trust - Tina Shturova-Chakreska

t.shturova@nhs.net

2020-07-07

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Patients age ≥ 18 years at screening 2. Hospitalisation with COVID-19 pneumonia AND - SARS-CoV2 infection (clinically suspected OR laboratory confirmed) AND - Radiological change consistent with COVID-19 disease 3. Grade 3 or 4 severity (WHO COVID-19 Ordinal Scale) 4. C-reactive protein (CRP) ≥50mg/L 5. Informed consent from patient or professional representative 6. No medical history that might, in the opinion of the responsible clinician, put the patient at significant risk if he/she were to participate in the trial 7. Agreement to abstain from sexual intercourse or use contraception that is >99% effective for all participants of childbearing potential for 42 days 8. For male participants, agreement to abstain from sperm donation for 42 days 9. Non-English speakers will be able to join the study. If patients are unable to understand verbal or written information in English - hospital translation services will be requested at the participating site for the participant where possible.

1. Requiring either invasive or non-invasive ventilation including continuous positive airway pressure (CPAP) or high flow nasal oxygen at any point before baseline 2. Grade ≥5 severity on the WHO COVID-19 Ordinal Scale 3. O2 saturation < 90% on ≥60% inspired oxygen at baseline 4. In the opinion of the investigator, progression to death is inevitable within the next 24 hours, irrespective of the provision of therapy 5. Known severe allergic reactions to the investigational agents 6. Use of drugs within the preceding 14 days that are known to interact with any study treatment 7. Child Pugh B or C grade hepatic dysfunction 8. End stage renal failure (ESRF) 9. Pregnant or breast feeding 10. Participation in other clinical trials

3

Joint Research Compliance Office

18

100

United Kingdom

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

186

The primary endpoint is progression from mild to severe COVID-19 pneumonia within 14 days in hospitalised patients. Patients are recruited at a WHO COVID-19 Severity Score of 3 and 4 and the primary endpoint is the comparison of patients whose COVID-19 pneumonia progresses to a severity score  5 on the modified WHO Ordinal Scale. Specifically, the primary endpoint is met when the following are recorded within 14 days: - Death - Requirement for invasive ventilation - Requirement for non-invasive ventilation including CPAP - O2 saturation < 90% on ≥60% inspired oxygen

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": "", "treatment_id": 1135, "treatment_name": "Ruxolitinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 525, "treatment_name": "Fostamatinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]