Trial NCT04364009
Publication ANACONDA - Audemard-Verger A, Plos One (2022) (published paper)
Dates: 2020-04-27 to 2020-10-06
Funding: Public/non profit (Tours university hospital)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / France
Follow-up duration (days): 28
Inclusion criteria
  • Confirmed SARS-CoV-2 infection: positive rRT-PCR and/or typical chest or computed tomographic scan of COVID 19 pneumonia and required oxygen therapy defined by either (i) O2 ≥ 4L/min to maintain Sp02> 92% and respiratory rate≥ 24/min or (ii) O2≥ 1L/min and oxygen requirement deterioration defined by an increase in oxygen therapy ≥ 2L/min to maintain Sp02> 92%
  • inflammatory component (reactive C-protein ≥ 50mg/L) and were treated with antibiotics (according to local practice)
Exclusion criteria
  • Need for mechanical ventilation or O2 > = 11 L/min in order to maintain Sp02> 92%
  • contra indication to anakinra and concurrent bacterial infection
Interventions
Treatment
Anakinra
Initial dose: 400mg/day (100mg IV every 6 hours) by IV for 3 days -
Maintenance dose: 200mg/day (100mg every 12 hours) by IV for 7 days. In case of renal failure (eGFR<30ml/min), anakinra was administrated 1 day out 2.
Control
Standard care

Participants
Randomized
participants :
Anakinra=37
Standard care=34
Characteristics of participants
N= 71
Mean age : NR
52 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: 0
Primary outcome
In the register
Treatment success [ Time Frame: After 14 days of treatment ] The primary endpoint is treatment success at Day 14, defined as a patient alive and not requiring any of the following: Invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO)
In the report
Treatment success at day 14, defined as a patient being alive and not requiring either of the following: invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO)
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

N
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 registry, protocol, and statistical analysis plan were available for data extraction and risk of bias assessment. The trial was terminated because of safety concerns therefore the study (n=71) did not achieve the target sample size (n=240).There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in registry reflects the primary outcome reported in the paper.