Covid-19 Living Data

Trial NCT04726098 ; EudraCT 2020-005702-25
Publication Taboada M, Eur Respir J (2021) (published paper)
Dates: 2021-01-15 to 2021-05-26
Funding: Public/non profit (Support was provided solely from institutional and departmental sources.)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Single center / Spain Follow-up duration (days): 60
Inclusion criteria	At least 18 years old SARS-CoV-2 infection confirmed by nasopharyngeal swab polymerase chain reaction 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)).
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 h 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.
Interventions
	Treatment DEX low dose 6 mg once daily for 10 days
	Control DEX high dose 20 mg once daily for 5 days, followed by 10 mg once daily for 5 days
Participants
	Randomized participants : DEX high dose=98 DEX low dose=102
	Characteristics of participants N= 200 Mean age : NR 123 males Severity : Mild: n=0 / Moderate: n=200 / Severe: n=0 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Percentage of patients with treatment failure at day 11 [ Time Frame: Day 11 after randomization ] defined as death, need of ICU and extracorporeal membrane oxygenation, need of non-invasive ventilation or nasal high-flow oxygen therapy, or worsening of the condition clinic of the patient during treatment (two of these: need to increase Fraction of inspired oxygen inspired>20%, need for fraction inspired oxygenation>50%, increase in respiratory rate>25, increase in inflammatory markers).
	In the report 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.
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Yes
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article, the trial registry and supplementary appendices were used in data extraction. Neither protocol nor statistical analysis plan was available. There were minor differences between the primary outcomes in the registry and the article and the extracted 28-day and 60-day outcome were not included in the registry. The study (n = 200) achieved its target sample size (n = 196).