COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04615871

Sorcha Mulligan

sorcha.mulligan@unityhealth.to

2020-11-04

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: symptomatic* covid-2 infection confirmed by a positive covid-19 test requiring hospitalization [or equivalent health care setting] with any two of the following high-risk features: age ≥ 60 years obesity (bmi >30) diabetes mellitus hypertension (on treatment or recently diagnosed)h coronary artery, cerebrovascular or peripheral vascular disease∫ chronic kidney disease (ckd) [egfr <60 ml/min/1.73m2 using the ckd epidemiology collaboration equation admission troponin >99% of uln admission d-dimer > 1µg/ml o2 saturation ≤93% e on room air or need for any o2 therapy

age <18 years history of pancreatitis history of multiple endocrine neoplasia or medullary thyroid cancer current use of a glp-1 receptor agonist [use of a dpp-4 inhibitor is allowed] positive beta-hcg (pregnancy test is mandated with baseline bloodwork for all female subjects ≤50 years of age breastfeeding, if they intend to continue breastfeeding elevation of serum lipase, direct (conjugated) bilirubin, or alkaline phosphatase (alp) more than 3x the upper limit of normal on baseline bloodwork history of decompensated heart failure with reduced ejection fraction (<35%) within 90 days, or known stable nyha class iv heart failure prior to their covid-19 illness imminent mechanical ventilation or death o2 therapy with high flow nasal cannula at fio2 >50% or already on mechanical ventilation any marker of hemodynamic instability at baseline defined as persistent sbp <90 mmhg after rehydration, or > 220 mmhg after receiving routine antihypertensive therapy, or hr <50 bpm or > 140 bpm after rehydration. inability to provide informed consent from patient or substitute decision maker (sdm)

2

Vladimír Džavík

18

100

Brazil;Canada;Mexico;United Kingdom

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

400

Composite of death or mechanical ventilation

None

Phase 2

[{"arm_notes": "", "treatment_id": 1183, "treatment_name": "Semaglutide", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]