A clinical trial to evaluate the effects of inhaled nitric oxide gas among COVID-19 patients with pneumonia

A phase II open-label, randomized, controlled feasibility trial to compare the antiviral activity and clinical efficacy of inhaled nitric oxide gas among COVID-19 patients diagnosed with pneumonia with hypoxic respiratory failure

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16806663

Enrollment

Registered

2021-03-11

Start date

2020-09-20

Completion date

Unknown

Last updated

2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult COVID-19 pneumonia patients with hypoxic respiratory failure Infections and Infestations COVID-19 (SARS-CoV-2 infection)

Interventions

Eligible patients will be randomized into two arms either receiving standard of care only (control arm), or standard of care and inhaled Nitric Oxide (iNO) using a helmet or tight sealing oronasal mas

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Severe acute respiratory infection (SARI) class 4 and 5 (hospitalized with the requirement of oxygen supplementation, high flow oxygen device, or non-invasive ventilation assistance) 2. Respiratory rates 90% with oxygen or Non-Invasive Ventilation (NIV)

Exclusion criteria

Exclusion criteria: 1. Mental obtundation at ICU admission 2. Contraindications or unwillingness to NIV 3. Requiring mechanical ventilation at ICU admission 4. Pre-enrollment diagnosis of chronic renal failure (CRF) or stage 1 Acute Kidney Injury (AKI) as per Kidney Disease Improving Global Outcomes (KDIGO) guidelines 5. Presence of hemoglobinopathies 6. Shock at presentation (mean arterial pressure 3% 8. Presence of baseline pulmonary artery hypertension 9. Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
Viral load as defined by cycle threshold measured using Real-Time Polymerase Chain Reaction Surrogate CT ratio from nasopharyngeal swab collected at baseline 3, 5, 7, 10, and 14 days	—

Secondary

Measure	Time frame
1. Duration of non-invasive ventilation (NIV) measured from the nursing chart and medical record evaluation recorded at 8 am and 8 pm daily by investigators during the study period collected at end of NIV 2. Duration of oxygen therapy measured from the nursing chart and medical record evaluation recorded at 8 am and 8 pm daily by investigators during the study period collected at end of oxygen therapy 3. Methaemoglobin levels measured using arterial blood gas analysis using a co- oximeter RADIOMETER ABL 800 on blood gas samples drawn after each pulse of iNO therapy at baseline, 1, 2, and 3 days 4. Incidence of methaemoglobin levels >3% during the trial measured using arterial blood gas analysis using a co- oximeter RADIOMETER ABL 800 on blood gas samples drawn after each pulse of iNO therapy at baseline, 1, 2, and 3 days 5. Severe acute respiratory infection (SARI) scale performance assessed during daily rounds by the clinical team collected daily until ICU discharge or achievement of the lowest numeric, whichever is earlier 6. Patient status measured using the Sequential Organ Failure Assessment (SOFA) score from medical chart/investigations obtained at 8 am at baseline and 72 h 7. Length of hospital stay measured from medical chart review on the day of hospital discharge 8. Length of intensive care unit (ICU) stay measured from medical chart review on the day of ICU discharge 9. Deaths measured by investigators for all patients in each arm and followed up daily recorded on the day of death or the immediate day after	—

Measure

Time frame

1. Duration of non-invasive ventilation (NIV) measured from the nursing chart and medical record evaluation recorded at 8 am and 8 pm daily by investigators during the study period collected at end of NIV 2. Duration of oxygen therapy measured from the nursing chart and medical record evaluation recorded at 8 am and 8 pm daily by investigators during the study period collected at end of oxygen therapy 3. Methaemoglobin levels measured using arterial blood gas analysis using a co- oximeter RADIOMETER ABL 800 on blood gas samples drawn after each pulse of iNO therapy at baseline, 1, 2, and 3 days 4. Incidence of methaemoglobin levels >3% during the trial measured using arterial blood gas analysis using a co- oximeter RADIOMETER ABL 800 on blood gas samples drawn after each pulse of iNO therapy at baseline, 1, 2, and 3 days 5. Severe acute respiratory infection (SARI) scale performance assessed during daily rounds by the clinical team collected daily until ICU discharge or achievement of the lowest numeric, whichever is earlier 6. Patient status measured using the Sequential Organ Failure Assessment (SOFA) score from medical chart/investigations obtained at 8 am at baseline and 72 h 7. Length of hospital stay measured from medical chart review on the day of hospital discharge 8. Length of intensive care unit (ICU) stay measured from medical chart review on the day of ICU discharge 9. Deaths measured by investigators for all patients in each arm and followed up daily recorded on the day of death or the immediate day after

—

Countries

India

Contacts

Public ContactAveek Jayant

jayant.aveek@gmail.com+91-484-2851234

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026