| Study characteristics |
| Methods |
Trial design: open‐label, randomised controlled trial
Type of publication: journal publication
Setting: inpatient
Recruitment dates: 15 January to 26 May 2021
Country: Spain
Language: English
Number of centres: 1
Trial registration number: NCT04726098, EUCTR2020‐ 005702‐25
Date first posted: 27 January 2021 |
| Participants |
Age: mean age
Gender:
Proportion of confirmed infections: confirmed SARS‐CoV‐2 infection by nasopharyngeal swab polymerase chain reaction was inclusion criterion
Ethnicity: not stated
Number of participants (recruited/allocated/evaluated)
Recruited: 681 Allocated: 98 high‐dose dexamethasone group, 102 in the low‐dose dexamethasone group Evaluated: 98 high‐dose dexamethasone group, 102 in the low‐dose dexamethasone group
Severity of condition according to study definition: receiving supplemental oxygen in order to maintain an oxygen saturation greater than 92%
Severity of condition according to WHO score: moderate to severe ≥ 5
Co‐morbidities: hypertension, hyperlipidaemia, obesity, diabetes, chronic pulmonary disease, asthma, cardiovascular disease, history of cancer, chronic kidney disease
Inclusion criteria:
At least 18 years old Had SARS‐CoV‐2 infection confirmed by nasopharyngeal swab polymerase chain reaction Were receiving supplemental oxygen in order to maintain an oxygen saturation greater than 92% (Level 4 using the World Health Organization 7‐point Ordinal Scale for clinical improvement (WHO‐CIS). Scores on the 7‐point ordinal scale WHO‐CIS were defined as follows: (1) Not hospitalised; (2) Hospitalised, not requiring supplemental oxygen, no longer requires ongoing medical care (independent); (3) Hospitalised, not requiring supplemental oxygen, but in need of ongoing medical care (COVID‐19 related or otherwise); (4) Hospitalised, requiring supplemental oxygen; (5) Hospitalised, requiring non‐invasive ventilation or high flow nasal cannula; (6) Hospitalised, requiring ICU admission and invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (7) Death
Exclusion criteria:
Pregnancy or active lactation Known history of dexamethasone allergy or known contraindication to the use of corticosteroids Indication for corticosteroids use for other clinical conditions (e.g. refractory septic shock) Daily use of oral or intravenous corticosteroids in the past 15 days Expected death within the next 48 hours Different level of 4 using the 7‐point ordinal scale WHO‐CIS, need of supplemental oxygen with fraction of inspired oxygen > 0.5 in order to maintain an oxygen saturation greater than 92% Consent refusal for participating in the trial
Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): ACE inhibitors, antihypertensive, anticoagulants, antiplatelet, inhaled corticosteroids, statins, immunosuppressants, insulin |
| Interventions |
Treatment details of intervention group (e.g. dose, route of administration, number of doses)
Type of corticosteroid: dexamethasone Dose: 20 mg once daily for 5 days, followed by 10 mg once daily for additional 5 days Route of administration: IV
Treatment details of control group (e.g. dose, route of administration, number of doses): dexamethasone, IV, 6 mg once daily for 10 days
Concomitant therapy (e.g. description of standard care): no
Duration of follow‐up: 28 days
Treatment cross‐overs: no
Compliance with assigned treatment: yes |
| Outcomes |
Primary study outcome: clinical worsening within 11 days since randomisation, defined as worsening of the patient's condition during treatment (need to increase fraction of inspired oxygen > 0.2, need for fraction of inspired oxygen > 0.5, respiratory rate > 25) or score higher than 4 on the 7‐point ordinal scale WHO‐CIS
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:
New need for invasive mechanical ventilation or death; that is, transition to WHO 7 to 9 if 6 or lower at baseline (see Figure 1). If new need was not available directly, we used death as a proxy for assumed intubation counted together with patients alive and ventilated: not reported
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: 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: time to recovery (defined as the first day after enrollment, on which a patient attained category 1, 2, or 3 on the 7‐point ordinal scale WHO‐CIS), clinical status of patients using the 7‐point ordinal scale WHO‐CIS at day 5, 11, 14, 28, and 60 days after randomisation, adverse drug reactions, number of patients admitted to the ICU, number of patients who needed mechanical ventilation, duration of mechanical ventilation, length of ICU and hospital stay, mortality during hospitalisation |
| Identification |
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| Notes |
Date of publication: 16 December 2021
Sponsor/funding: Manuel Taboada Muñiz |
