COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04383002

Jennifer Lister

Jennifer.Lister@uhn.ca

2020-05-11

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: confirmed infection with covid-19 positive rt-pcr tracheal aspirate prior to treatment use of mechanical ventilation with or without ecmo male or female ages > 18 years < 14 days from symptom initiation to study enrolment and < 7 days from intubation to study enrolment

patients on other interventional clinical trials subjects diagnosed with congestive or unstable heart disease including heart failure, left ventricular dysfunction (lvef < 40 %) or myocardial damage, severe pulmonary hypertension and/or unstable hypertension subjects diagnosed with immunodeficiency hematology: patients with clinically significant anemia e.g. hemoglobin < 100 and thrombocytopenia e.g. platelets < 75 subjects with clinically significant history of, or active bleeding including active pulmonary or gastrointestinal bleeding hepatic function: patients with abnormal liver function defined as any two of the following alt >3x uln, ast >3x uln, total bilirubin < 1.5 x uln patient receiving drugs that have a contraindication with no e.g. use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine or dapsone at screening as relevant to the proposed study population pregnancy subjects with a known hypersensitivity to methylene blue, subjects with glucose-6-phosphate dehydrogenase (g6pd) deficiency known or suspected thalassemia, sickle cell disease, or other conditions associated with poor oxygen carrying capacity

2

University Health Network, Toronto

18

None

Canada

Critical disease at enrollment

8: Critical disease at enrollment

21

COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate

None

Phase 1

[{"arm_notes": "", "treatment_id": 890, "treatment_name": "Nitric oxide gas", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]