Covid-19 Living Data

Trial IRCT20120703010178N20
Publication Kharazmi AB, Immun Inflamm Dis (2021) (published paper)
Dates: 2020-05-01 to 2020-07-30
Funding: Private (Persisgen Par Pharmaceutical Company)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Single center / Iran Follow-up duration (days): 14
Inclusion criteria	Confirmed diagnosis of COVID‐19 based on the reverse transcriptase‐polymerase chain reaction Admitted to the intensive care unit (ICU) age of 18 years old or more Elevated C‐reactive protein (CRP) levels Oxygen saturation less than or equal to 93% measured using a peripheral capillary pulse oximeter Fever (core temperature of 37.8°C or more), or cough or shortness of breath PaO2/FiO2 less than 300
Exclusion criteria	Positive results for tuberculosis (i.e., positive Mendel–Mantoux or QuantiFERON test) Viral hepatitis B or C Hemoglobin less than 7.5 g/dl Platelet count of fewer than 100,000 cells/µl Serum glutamic–oxaloacetic transaminase, or serum glutamic–pyruvic transaminase more than five upper limits of normal Untreated active infection Previous administration of canakinumab or anakinra
Interventions
	Treatment Anakinra 100 mg/day intravenously for up to 14 days
	Control Standard care
Participants
	Randomized participants : Anakinra=15 Standard care=15
	Characteristics of participants N= 30 Mean age : NR 19 males Severity : Mild: n=0 / Moderate: n=9 / Severe: n=16 Critical: n=5 Number of vaccinated participants: NR
Primary outcome
	In the register 1) No need for hospitalization; 2) Hospitalization without need for oxygenation therapy; 3) Hospitalization with oxygen therapy; 4) Hospitalization with receiving non-invasive ventilation or high flow oxygen cannula; 5) Hospitalization with receiving mechanical ventilation or extra-corporeal membrane oxygenation ; 6) Death (During first 14 days or hospitalization period)
	In the report Need for endotracheal intubation due to hypoxemia
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 retrospective trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcome in the article (mechanical ventilation) differed from that in the registry (score on a 7-point ordinal scale). As the registry is retrospective, there is no information on whether the sample size, outcomes or data analysis were determined a-priori. Patients in the control group were considerably older than the treatment group (mean 59.00 ± 1.79 years versus 49.25 ± 19.12) and more had hypertension (53.3% versus 13.3%), diabetes (53.3% versus 20.0%) and coronary artery disease (33.3% versus 20.0%). The study (n = 30) achieved its target sample size (n = 30).