Covid-19 Living Data

Trial IRCT20151227025726N23
Publication Fakharian A, Int Immunopharmacol, 2021 (published paper)

Funding: Public/non profit (Shahid Beheshti University of Medical Sciences)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Single center / Iran Follow-up duration (days): *
Inclusion criteria	18 to 70 years old; confirmed COVID-19 (using Reverse Transcription-Polymerase Chain Reaction (RT-PCR) reports and Computed Tomography (CT) scan confirming bilateral pulmonary infiltration); classified as severe or critical (SpO2 ≤ 93% at room air, heart rate ≥ 125 min, respiratory rate ≥ 30/min, evidence of shock, need for mechanical ventilation or vasopressors, clinically significant acute hepatic, renal or neurological dysfunction due to COVID-19 and acute respiratory distress syndrome)
Exclusion criteria	non-consent; acute or chronic kidney disease (rise in serum creatinine by more than 0.3 mg/dl during 48 h or glomerular filtration rate lower than 30 ml/min); history of liver failure (Child-Pugh stage C and D or more than 5 times rise above the upper limit of normal in liver function tests or 3 times in patients with symptoms of liver failure); history of malignancy; history of heart failure; latent or active tuberculosis or any active infection; receiving medications affecting IL-6 or TNF-α levels; active peptic ulcer disease; history of an allergic reaction to adalimumab or developing allergic reaction while receiving the medication; mildly ill patients; pregnancy or breastfeeding
Interventions
	Treatment Adalimumab 40 mg subcutaneously once-off
	Control Standard care ( / ) Definition of Standard care: Oxygen and fluid support, remdesivir 200 mg stat followed by 100 mg intravenously daily for five to ten days, and dexamethasone 6 mg intravenously daily for ten days or up to the point of discharge
Participants
	Randomized 68 participants (n₁=34 / n₂= 34)
	Characteristics of participants N=68 Mean age : 54.6 40 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=* Critical: n=*
Primary outcome
	In the register Clinical improvement (hospital discharge), clinical improvement (length of time in which patient needs oxygen therapy), need for mechanical ventilation, 28 days mortality
	In the report Requiring invasive mechanical ventilation, the necessity of admission to the Intensive Care Unit (ICU), and the rate of mortality
Documents available	Protocol NR Statistical plan NR Data-sharing stated
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 study registry was used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the trial registry. There was a change from the trial registration in the intervention and control treatments (e.g. the drugs used for standard care). The registry primary outcomes do not reflect the reported primary outcomes. Some outcomes from the registry are not reported in the paper (e.g. timepoint for mortality, length of time in which patient needs oxygen therapy, RT-PCR result day 5).