| Study characteristics |
| Methods |
Trial design: open‐label RCT
Type of publication: journal publication
Setting: inpatient
Recruitment dates: recruitment ended on 8 June 2020
Country: UK
Language: English
Number of centres: 176
Trial registration number: NCT04381936
Date of trial registration: 11 May 2020 |
| Participants |
Age: mean age
Gender
Proportion of PCR test results
Positive: 89% intervention arm, 90% control arm Negative: 11% intervention arm, 10% control arm Unclear: 1% intervention arm, < 1% control arm
Ethnicity: not reported
Number of participants (recruited/allocated/evaluated):
Severity of condition according to study definition
No oxygen: 501 (24%) intervention group; 1034 (24%) control group Oxygen only: 1279 (61%) intervention group; 2604 (60%) control group IMV: 324 (15%) intervention group; 683 (16%) control group
Severity of condition according to WHO score: moderate to severe 4 to 9
Co‐morbidities: diabetes, heart disease, chronic lung disease, tuberculosis, HIV infection, severe liver disease, severe kidney impairment
Inclusion criteria
Clinically suspected or laboratory confirmed SARS‐CoV‐2 infection Hospitalised patients: 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
Exclusion criteria
If the attending clinician believes that there is a specific contra‐indication to one of the active drug treatment arms or that the patient should definitely be receiving one of the active drug treatment arms then that arm will not be available for randomisation for that patient For patients who lack capacity, an advanced directive or behaviour that clearly indicates that they would not wish to participate in the trial would be considered sufficient reason to exclude them from the trial
Previous treatments: not reported |
| Interventions |
Treatment details of intervention group (e.g. dose, route of administration, number of doses)
Type of corticosteroid: dexamethasone Dose: 6 mg once daily for up to 10 days (or until hospital discharge if sooner) Route of administration: IV or oral
Treatment details of control group (e.g. dose, route of administration, number of doses)
Concomitant therapy (e.g. description of standard care): none
Duration of follow‐up: until discharge or death, or 28 days after randomisation
Treatment cross‐overs: no
Compliance with assigned treatment: 8% in the control group received intervention drug |
| Outcomes |
Primary study outcome: 28‐day mortality
Review outcomes: inpatient setting
Mortality: all‐cause mortality at day 14 or any longer observation period, in‐hospital all‐cause mortality: reported -
Improvement of clinical status during the longest observation period available:
Ventilator‐free days (defined as days alive and free from mechanical ventilation): not reported Participants discharged alive. Participants should be discharged without clinical deterioration or death: reported
-
Deterioration of clinical status during the longest observation period available:
Serious adverse events, defined as the number of participants with any event: not reported Adverse events (any grade), defined as the number of participants with any event: not reported Specific adverse events: hospital‐acquired infections: not reported Fungal infections: not reported Quality of life, including fatigue and neurological status, assessed with standardised scales (e.g. WHOQOL‐100) during the longest period available: not reported New need for dialysis during the longest period available: not reported Viral clearance, assessed with reverse transcription polymerase chain reaction (RT‐PCR) test for SARS‐CoV‐2 at baseline, up to 3, 7, and 15 days: not reported
Additional study outcomes: composite outcome IMV or death |
| Identification |
|
| Notes |
Date of publication: 17 July 2020
Sponsor/funding: University of Oxford |
