COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-8nfx26

Marcus Jones

mhjones@pucrs.br

2020-09-22

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Protocol A Hospitalized patients with proven or high suspicion of coronavirus infection, signing a consent form and/or assent, older than 10 years. Score clinical 4 (receiving supplemental oxygen). Protocol B Non hospitalized patients with proven or high suspicion of coronavirus infection, signing a consent form and/or assent, older than 10 years. Score clinical 2 (at home with limitations).

Protocol A Participant in any other clinical trial of an experimental treatment for COVID-19, pregnancy, clinical contraindication of the attending physician, use of a nitric oxide donor agent, such as nitroglycerin or drugs known to increase methaemoglobin, such as lidocaine, prilocaine, benzocaine or dapsone, heart failure, left ventricular dysfunction, history of hemoptysis. Protocol B Participant in any other clinical trial of an experimental treatment for COVID-19, Pregnancy, clinical contraindication of the attending physician, indication for hospitalization at the time of evaluation, use of a nitric oxide donor agent, such as nitroglycerin or drugs prepared by increasing methemoglobin, such as lidocaine, prilocaine, benzocaine, or dapsone, heart failure, left ventricular dysfunction, hx of hemoptysis.

2

Pontifícia Universidade Católica do Rio Grande do Sul - PUCRS

10

100

Brazil

Moderate disease at enrollment

3: Moderate disease at enrollment

0

It is expected to evaluate the days without respiratory support (supplemental oxygen; CNAF; NIV; VM; ECMO) in 15 days. A live day without respiratory support was defined as any day on which the patient did not receive supplemental oxygen or invasive or non-invasive mechanical ventilation; from randomization to the 15th. Considering an average of 11 days and a standard deviation of 5 days in free days of ventilatory support; 110 patients (55 for each arm) will be sufficient to detect an average difference of 3 days between the study groups (experimental vs control); with 80% power and a two-tailed alpha of 0; 05. A value of 0 will be assigned to patients who died during the 15-day window.

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": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]