COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04390464

Elena Hernan-Sancho

elena.hernansancho@addenbrookes.nhs.uk

2020-05-15

Unknown

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria to be included in the trial the participant must: be aged 18 and over have clinical picture strongly suggestive of covid-19-related (with/without positive covid-19 test) and risk count (as defined below) >3 or ≥ 3 if risk count includes "radiographic severity score >3" be considered an appropriate subject for intervention with immunomodulatory in the opinion of the supervising clinician be able to be maintained on venous thromboembolism prophylaxis or current maintenance therapy during inpatient dosing period, according to local guidelines exclusion criteria the presence of any of the following will preclude participant inclusion: inability to supply direct informed consent or assent from next of kin or independent healthcare provider on behalf of patient mechanical ventilation at time of prior to dosing contraindications to study drugs, including hypersensitivity to the active substances or any of the excipients currently on any of the study investigational medicinal products known unresolved neisseria meningitidis infection unwilling to be vaccinated against neisseria meningitidis or receive prophylactic antibiotic cover until 2 weeks after vaccination known active tuberculosis (no blood screening required) known active hepatitis b or c (no blood screening required); active varicella zoster concurrent participation in any interventional clinical trial including covid-19-related disease trials (observational studies allowed) patient moribund at presentation or screening pregnancy at screening (or unwillingness to adhere to pregnancy advice in protocol) unwillingness to adhere to breastfeeding advice in protocol either alanine transaminase or aspartate transaminase (alt or ast) > 5 times the upper limit of normal stage 4 severe chronic kidney disease or requiring dialysis (i.e. cockcroft gault estimated creatinine clearance < 30 ml /min/1.73 m^2) currently receiving probenecid or chronic ivig treatment any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern. risk count patients will be given a risk count equal to the cumulative points received for the following criteria (no = 0 points, yes = 1 point): male gender, age > 40 years, non-white ethnicity, diabetes, hypertension, neutrophils > 8.0x10^9/l, crp > 40mg/l, radiographic severity score >3

None

3

Cambridge University Hospitals NHS Foundation Trust

18

None

United Kingdom

Moderate disease at enrollment

3: Moderate disease at enrollment

1167

Time to incidence of the composite endpoint of: Death, Mechanical ventilation, ECMO, Cardiovascular organ support, or Renal failure

None

Phase 4

[{"arm_notes": "", "treatment_id": 181, "treatment_name": "Baricitinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1065, "treatment_name": "Ravulizumab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]