COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04456088

Rinat Kalaora

rkalaora@beyondair.net

2020-07-02

Withdrawn

RCT

Randomized

Parallel

Open label

unclear

Treatment

inclusion criteria: patients (male and female) admitted to the hospital for covid-19 patients with oxygen saturation less than 93 % on room air shortness of breath, with symptom onset within the previous 8 days. ability to understand and comply with study requirements . signed informed consent by subject

patients who are treated with or require high flow nasal cannula, cpap, intubation, mechanical ventilation, or tracheostomy diagnosis of acute respiratory distress syndrome breastfeeding or pregnancy as evidenced by a positive pregnancy test. subjects diagnosed with immunodeficiency, with history of congestive or unstable heart disease, left ventricular dysfunction (lvef <40%) or myocardial damage, severe pulmonary hypertension and/or unstable hypertension history of frequent epistaxis (>1 episode/month). significant hemoptysis during the last 30 days prior to enrollment methemoglobin level >3% at screening patients on systemic steroids (any formulation) within 30 days prior to enrollment. history of daily, continuous oxygen supplementation patients with bmi greater than or equal to 36 patient receiving drugs that have a contraindication with no, patients with clinically significant anemia, e.g., hb <100 g/l and thrombocytopenia, e.g., platelets <75 thousand cells/mcl. presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data, e.g., known or suspected thalassemia, sickle cell disease or other diseases associated with poor oxygen carrying capacity. the subject is identified by the investigator as being unable or unwilling to perform study procedures.

3

Beyond Air Inc.

22

75

None

Severe disease at enrollment

6: Severe disease at enrollment

0

Time to deterioration

None

Phase 2

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