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NO-COVID

Title Prevention of COVID-19 Progression Through Early Administration of Inhaled Nitric Oxide
Therapeutic Area Covid-19
Principal Investigator Marvin A. Konstam, MD
Min Age 18 Years
Max Age 80 Years
Gender All
Contact By Invitation Only
More Information https://clinicaltrials.gov/ct2/show/NCT04388683

Overview

The purpose of this study is to investigate the potential for inhaled NO to reduce clinical worsening of hospitalized, high-risk patients with early COVID-19 to progressive systemic de-oxygenation, intubation, and death. This is a pilot randomized-controlled (2:1) open label investigation of inhaled NO to prevent progression to more advanced disease in hospitalized patients with COVID-19 at risk for worsening, based on baseline systemic oxygenation and 2 or more of the major risk factors of age  60 years, type II DM, hypertension, and obesity.

Study Details

Inclusion Criteria

  1. Diagnosis of COVID-19 based on either
    1. positive nasal or oral pharyngeal swab by PCR, or
    2. highly probable clinical picture based on clinical and CXR/CT scan
  2. Room air oxygen saturation of < 92% on £ 5L/min flow O2
  3. At least 2 of the following 4 risk factors for clinical worsening:
    1. Age ≥ 60 years
    2. T2DM or pre-diabetes as evidenced by either treatment with a hypoglycemic agent or any documented HgA1c ³ 5.6
    3. Obesity, based on BMI ≥ 30 kg/m2
    4. Hypertension, based on treatment with an antihypertensive medication or systolic or diastolic blood pressure measurement ³ 140 or ³ 90 mmHg, documented at enrollment or at any time within the prior 6 months.

Exclusion Criteria

  1. Intubated or anticipated intubation within the subsequent 2 hours.
  2. Receiving > 5L/min flow O2, or non-invasive ventilation.
  3. Other major pulmonary, cardiac, or systemic illness or disease involvement with potential to represent the primary driver for clinical deterioration within the next 3 days.

Study Requirements

The participant will remain in the study receiving treatment of inhaled Nitric Oxide (if randomized to treatment arm) for up to 2 weeks, unless the participant deteriorates and requires escalation to high flow or intubation in which case treatment will be stopped. The participant will be followed up with through discharge, death, or 28 days post randomization. Follow up includes oxygen saturation, PaO2, and any adverse events. Baseline assessments include measurement of oxygen saturation and baseline blood draw, including arterial blood gases. A second blood draw will occur at the end of treatment. Each blood draw will collect about 2/3 of a tablespoon of blood, with a total of less than 2 tablespoons of blood being collected throughout the study.