Trial NCT04643678
Publication Elmekaty E, medRxiv (2022) (preprint)
Dates: 2020-10-30 to 2021-04-30
Funding: Public/non profit (Hamad Medical Corporation, Qatar)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Qatar
Follow-up duration (days): 28
Inclusion criteria
  • Hospitalized
  • adults (age ≥ 18yrs)
  • confirmed COVID-19 diagnosis by positive SARS-CoV2 Polymerase Chain Reaction (PCR) test
  • associated presence of respiratory distress [defined as: PaO2/FiO2 ≤ 300 mm Hg or respiratory Rate (RR) 152 ≥24 breaths/min or SpO2 ≤ 94% at room air]
  • signs of cytokine release syndrome [defined as any of the following at baseline: Ferritin >600 mcg/L at presentation or >300 mcg/l with doubling within 24 hours, LDH >250 IU/L, D-dimers > 1 mg/L, CRP > 70mg/L and rising since last 24h with the absence of bacterial infection, Interleukin-6 level > 10 x UNL (reference range ≤7 pg/ml)]
  • radiological evidence of pneumonia based on chest X-ray and/or computed tomography (CT) scan findings
  • signed informed consent provided by the patient, or by the patient's legal representative.
Exclusion criteria
  • Known serious allergic reactions including anaphylaxis to the study medication or any component of the product
  • active infectious diseases such as active bacterial infections (defined as the isolation of bacteria from a sterile body site or other body sites and is causing clinical symptoms and signs and therefore are treated with antibiotics)
  • invasive fungal infections
  • Human Immunodeficiency Virus (HIV) Hepatitis B Virus (HBV) infection
  • Hepatitis C Virus (HCV) infection
  • active tuberculosis
  • patients on immunosuppressants or immunomodulatory drugs or had received any in the past 30 days
  • neutrophil count below 500 cells/microliter
  • platelets below 50,000/microliter
  • pregnant or breastfeeding females.
Interventions
Treatment
Anakinra
Initial dose: 100 mg subcutaneous (SC) injection every 12 hours for 3 days - Maintenance dose: 100 mg SC once daily from day 4 to day 7
Control
Standard care

Participants
Randomized
participants :
Anakinra=40
Standard care=40
Characteristics of participants
N= 80
Mean age : NR
66 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=77 Critical: n=3
Number of vaccinated participants: NR
Primary outcome
In the register
Treatment Success at day 14 [ Time Frame: Day 14 ] Defined as WHO Clinical Progression score of ≤3 [Ambulatory mild disease: symptomatic; assistance needed].
In the report
Treatment success on day 14, defined as a WHO Clinical Progression score of ≤3 [Ambulatory mild disease: symptomatic, assistance needed]
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 preprint article, the retrospective study registry was used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. As the registry was retrospective, we are unable to determine if the sample size, interventions and outcomes were determined a priori."