Covid-19 Living Data

Trial IRCT20100228003449N31
Publication Toroghi N, Pharmacol Rep (2021) (published paper)
Dates: 2020-10-26 to 2021-01-15
Funding: Public/non profit (Tehran University of Medical Sciences)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Single center / Iran Follow-up duration (days): 60
Inclusion criteria	Hospitalized adult patients above 18 years old with moderate to severe COVID-19 required supplemental oxygen
Exclusion criteria	History of allergy to corticosteroids uncontrolled diabetes mellitus with serum glucose above 250 mg/dL active fungal or parasitic infections closed-angle glaucoma history of myopathy history of corticosteroid-induced neuropsychiatric disorders uncontrolled cardiovascular diseases like acute coronary syndrome, myocardial infarction, acute and massive thrombosis uncontrolled hypertension (systolic blood pressure above 140 mmHg and diastolic blood pressure above 90 mmHg) acute viral hepatitis pregnancy and lactation history of corticosteroid therapy (for more than two weeks) patients with critical COVID-19 (condition that would require the provision of life-sustaining therapies such as mechanical ventilation or vasopressor therapy)
Interventions
	Treatment DEX low dose 8 mg orally once a day for up to 10 days or discharge DEX intermediate 8 mg orally twice a day for up to 10 days or discharge
	Control DEX high dose 8 mg orally three times a day for up to 10 days or discharge
Participants
	Randomized participants : DEX low dose=48 DEX intermediate=48 DEX high dose=48
	Characteristics of participants N= 144 Mean age : NR 80 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register 1) Improvement of patients' chief complaint 2) Improvement in peripheral blood oxygen saturation 3) Decrease in serum CRP 4) Hyperglycemia 5) Changes in mood 6) Myopathy 7) Secondary infections
	In the report Time to a clinical response that was described as improvement of at least two scores in the eight-category ordinal scale of the National Institute of Health
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 materials were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcome in the published article (an improvement of two or more points on an 8-point ordinal scale) broadly reflects one of the outcomes in the registry (improvement of patient’s chief complaint). Other primary outcomes in the registry were reported as secondary outcomes. The trial (n = 144) achieved its target sample size (n = 144).