Trial NCT04473053; ISRCTN14212905; EudraCT 2020-002230-3
Publication DEFINE - Quinn TM, EBioMedicine (2022) (published paper)
Dates: 2020-09-01 to 2021-02-28
Funding: Mixed (LifeArc and Oxford University COVID-19 Research Response Fund. Nichi-Iko (Japan) supplied Futhan (intravenous Nafamostat) for the trial.)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / UK
Follow-up duration (days): 131
Inclusion criteria
  • Over the age of 16
  • confirmed SARS-CoV-2 infection by RT-PCR
  • chest radiographic changes consistent with COVID-19, or an additional oxygen requirement
Exclusion criteria
  • Pregnancy
  • lactation
  • inability to reliably take or tolerate modes of delivery of the treatment
  • required anticoagulation, antiplatelet therapy or potassium sparing diuretics which could not reasonably be withheld
  • current or recent history of severe uncontrolled cardiac disease, diabetes mellitus, renal impairment or hepatic impairment, anaemia, thrombocytopaenia, hyponatraemia or hyperkalaemia
Interventions
Treatment
Nafamostat
0.2 mg/kg/hr continuous infusion for 7 days
Control
Standard care

Participants
Randomized
participants :
Nafamostat=23
Standard care=21
Characteristics of participants
N= 44
Mean age : NR
25 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
1) The safety of the candidate therapies in COVID-19 patients by measuring physiological changes in the circulatory and respiratory system. [ Time Frame: Up to 16 days post treatment ]; 2) The safety of the candidate therapies in COVID-19 patients by recording the number of treatment related adverse events. [ Time Frame: Up to 90 days post treatment ]
In the report
safety and tolerability of intravenous nafamostat as an add on therapy for patients hospitalised with COVID-19 pneumonitis.
Documents
available

Protocol

Yes. In English

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 pre-print and published articles, the protocol and study registries were used in data extraction and risk of bias assessment. The primary outcomes in the article broadly reflect those in the registry. The two arms in the platform trial reported in the article along with a third unreported arm (n = 66 in total) appear not to have achieved the target sample size in the registry (n = 200).
This study was updated on May 11th, 2022 with data extracted from the peer-reviewed report.