COVID-19 (infection with SARS-CoV-2 virus) MedDRA version: 21.1 Level: PT Classification code 10035737 Term: Pneumonia viral System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1 Level: PT Classification code 10061982 Term: Severe acute respiratory syndrome System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Hydrocortisone
Pharmaceutical Form:
INN or Proposed INN: Hydrocortisone
Trade Name: RoActemra
Product Name: RoActemra
Pharmaceutical Form:
INN or Proposed INN: Tocilizumab
Concentrati
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible for the study if all of the following are true: (i) Hospitalised (ii) SARS-CoV-2 infection (suspected or confirmed) (iii) No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial In addition, if the attending clinician believes that there is a specific contra-indication (see Appendix 2; section 8.2) to one of the active drug treatment arms, then the patient will not be excluded from randomisation to that arm. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10000
Exclusion criteria
Exclusion criteria: Participants may be excluded from receiving one or more of the possible randomised options if their medical history suggests that a treatment may be contraindicated. Corticosteroids: none. Azithromycin: known long QT syndrome Convalescent plasma: known moderate or severe allergy to blood products REGN10933+REGN10987: IVIg use during admission for COVID-19 Aspirin: age 1 of these is present, investigator should consider not including colchicine in randomisation. • Concomitant use of moderate CYP3A4 inhibitor (e.g. diltiazem) • Renal impairment: eGFR <30 mL/min/1.73m2 (either chronic or acute)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to provide reliable estimates of the effect of study treatments on death within 28 days of randomisation (with subsidiary analyses of cause of death).;Secondary Objective: The secondary objectives are to assess the effects of study treatments on duration of hospital stay and on need for (and duration of) ventilation or renal replacement therapy.;Primary end point(s): All-cause mortality within 28 days of randomisation.;Timepoint(s) of evaluation of this end point: 28 days after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duration of hospitalisation Use of ventilation ;Timepoint(s) of evaluation of this end point: 28 days | — |
Countries
Indonesia, Nepal, United Kingdom, Vietnam
Outcome results
None listed