COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04659460

Sandy Trpcic

Sandy.Trpcic@unityhealth.to

2020-12-09

Unknown

RCT

Randomized

Crossover

Blind label

single-center

Treatment

inclusion criteria: - age > 16 years old - admission to icu - either confirmed positive, or presumed, covid-19 disease - radiological evidence of covid-related pneumonia (cxr or ct abnormalities indicating covid-19 pneumonia; such as, ground-glass opacities) - able to safely undergo conditioning of the arm - no peripheral vascular disease - no evidence of prior arm surgery - no evidence of prior radiation or lymph node dissection - clinical staff deems it safe to proceed (yes/no: signed by mrp)

- age <16 years - unable to safely undergo conditioning - known peripheral vascular disease - evidence of prior arm surgery - evidence of prior radiation or lymph node dissection - clinical staff deems it unsafe (yes/no: signed by mrp) - no radiological evidence of covid-related pneumonia - hemodynamically unstable: patients with sbp 90 or sbp 180 excluded until hemodynamically stabilized, then reassessed for inclusion - anti-coagulation drug use

2

Unity Health Toronto

16

100

None

Critical disease at enrollment

8: Critical disease at enrollment

30

International Normalized Ratio (INR);Rotational Thromboelastometry (ROTEM);Tumour Necrosis Factor Alpha (TNFa) (pg/mL);Neutrophil to Lymphocyte Ratio (NLR) (absolute neutrophils/lymphocytes);C-reactive protein (CRP) (mg/mL);Serum Ferritin (ng/mL);Interleukin 6 (IL-6) (pg/mL);Prothrombin Time (PTT);Interleukin 1-Beta (IL-1B) (pg/mL)

None

Not reported

[{"arm_notes": "", "treatment_id": 1101, "treatment_name": "Remote ischemic conditioning", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]