| Study characteristics |
| Methods |
Trial design: multicenter, open‐label RCT
Type of publication: journal publication
Setting: inpatient
Recruitment dates: 17 April‐23 June 2020
Country: Brazil
Language: English
Number of centres: 41
Trial registration number: NCT04327401
Date of trial registration: 31 March 2020 |
| Participants |
Age: mean 60.1 years (SD 15.8) intervention group and 62.7 years (SD 13.1) control group Gender: 90 (59.6%) male and 61 (40.4%) female in the intervention group; 97 (65.6%) male and 51 (34.5%) female in the control group -
Proportion of PCR test results:
Positive: 95.4% intervention arm, 95.9% control arm Negative: 0% intervention arm, 0.7% control arm Unclear: 4.6% intervention arm, 3.4% control arm
Ethnicity: not reported Number of participants (recruited/allocated/evaluated): 545/151 intervention group and 148 control group/151 intervention group and 148 control group Severity of condition according to study definition: all participants were mechanically ventilated Severity of condition according to WHO score: severe 7‐9 Co‐morbidities: hypertension, diabetes, obesity, heart failure, chronic kidney failure -
Inclusion criteria:
At least 18 years old Confirmed or suspected COVID‐19 infection Receiving mechanical ventilation within 48 hours of meeting criteria for moderate to severe ARDS with partial pressure of arterial blood oxygen to fraction of inspired oxygen (PaO2:FIO2) ratio of 200 or less
-
Exclusion criteria:
Pregnancy or active lactation Known history of dexamethasone allergy Corticosteroid use in the past 15 days for non‐hospitalised patients Use of corticosteroids during the present hospital stay for more than 1 day Indication for corticosteroid use for other clinical conditions (eg, refractory septic shock) Use of immunosuppressive drugs Cytotoxic chemotherapy in the past 21 days Neutropenia due to hematological or solid malignancies with bone marrow invasion Consent refusal Expected death in the next 24 hours
Previous treatments: no |
| 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 intravenously once daily for additional 5 days or until ICU discharge Route of administration: intravenous
Treatment details of control group (e.g dose, route of administration, number of doses): standard care
Concomitant therapy (e.g description of standard care): hydroxychloroquine, azithromycin, other antibiotics, oseltamivir
Duration of follow‐up: 28 days
Treatment cross‐overs: no
Compliance with assigned treatment
25 deviations from protocol in the intervention arm (16.55%) 1 patient received a corticosteroid other than dexamethasone In the control arm, 52 patients received corticosteroids, of which 14 were protocol deviations (9.4%)
|
| Outcomes |
Primary study outcome: number of days alive and free from mechanical ventilation for at least 48 consecutive hours
Review outcomes: Inpatient setting
All‐cause mortality at day 21, or longest observation period: reported -
Improvement of clinical status during observation period:
Liberation from IMV in participants i.e. transition to WHO ≤ 6 if ≥ 7 at baseline (see Figure 1). If liberation was not available directly, death was used as a proxy for assumed non‐liberation counted together with participants alive and ventilated: reported Ventilator‐free days and alive: reported
-
Worsening of clinical status during observation period:
Need for dialysis (at up to 28 days): not reported Quality of life, including fatigue and neurological status, assessed with standardised scales (e.g. WHOQOL‐100) at longest follow‐up available: not reported Viral clearance, assessed with RT‐PCR test for SARS‐CoV‐2 at baseline, up to 3, 7, and 15 days: not reported Serious adverse events: reported Adverse events (any grade): reported Hospital‐acquired infections: reported
Additional study outcomes: Sequential Organ Failure Assessment (SOFA) scores |
| Identification |
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| Notes |
Date of publication: 2 September 2020
Sponsor/funding: this trial was funded and supported by the Coalition COVID‐19 Brazil. The Laboratórios Farmacêuticos provided the study drug, distribution logistics, and insurance for the study patients |
