COVID-19 trials registries data warehouse

http://www.isrctn.com/ISRCTN16806663

Aveek Jayant

jayant.aveek@gmail.com

2021-03-11

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

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

2

Amrita Institute of Medical Sciences and Research Centre

18

100

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

25

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

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"}]