A clinical trial to evaluate the effects of inhaled nitric oxide gas among COVID-19 patients with pneumonia
- Conditions
- Adult COVID-19 pneumonia patients with hypoxic respiratory failureInfections and InfestationsCOVID-19 (SARS-CoV-2 infection)
- Registration Number
- ISRCTN16806663
- Lead Sponsor
- Amrita Institute of Medical Sciences and Research Centre
- Brief Summary
2022 Results article in https://dx.doi.org/doi: 10.1097/IM9.0000000000000079 (added 11/08/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 29
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 <30 and saturating >90% with oxygen or Non-Invasive Ventilation (NIV)
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 <60)
7. History of G6PD deficiency or baseline methemoglobin >3%
8. Presence of baseline pulmonary artery hypertension
9. Pregnancy or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method