Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: B338- Other specified viral diseases
Conditions
Interventions
Intervention1: pulsed inhaled nitric oxide: Administer pulsed inhaled nitric oxide at 160 ppm for 30 mins once a day for 5 days
Control Intervention1: Room air: Subjects who shall not be administered
Sponsors
Sir h n Reliance Foundation hospital and research centre
Eligibility
Inclusion criteria
Inclusion criteria: Adults, 18 â?? 50 years(account for 60% of cases in India as on May 6, 2021), with positive rtPCR and consenting to the study within 48 hours of diagnosis, already admitted or willing to get admitted to the COVID facility at SevenHills Hospital, managed by Sir H N Reliance Foundation Hospital, with asymptomatic or mildly symptomatic symptoms.
Exclusion criteria
Exclusion criteria: A.Comorbid factors: 1. Smoker 2. Hypertension or hypotension 3. Diabetes Mellitus 4. Renal injury or failure 5. Known abnormal Haemoglobinopathies 6. Known clinically significant Pulmonary Arterial Hypertension 7. Known congenital heart disease operated or otherwise 8. Heart Failure (LVF B.Other factors: 1. Additional treatment with Steroids, Tocilizumab, Plasma therapy. 2. Requiring supplemental oxygen to maintain saturations > 93% 3. Needing intubation and mechanical ventilation 4. Past history of documented COVID-19 infection 5. Completed COVID vaccination. 6. Pregnant women, confirmed or suspected 7. Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study 8. Current smoker - Current smokerâ?? is someone who has smoked greater than 100 cigarettes in their lifetime and has smoked in the last 28 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of days to negative rtPCR or decrease viral load reflected in the ct values 35 2. Number of patients in room air progressing to O2 supplementation, or further advanced medications or ventilation in first 10 days. 3. Reduction in number of hospital days 4. Reduction in Morbidity and mortality. Timepoint: 3 months trial and data collection 3 months data analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the change in ct values between the 2 groups 2. Number of subjects who progressed to supplemental oxygen therapy 3. Number of subjects who progressed to any form of ventilation 4. Duration of hospitalization compared in both groups. 5. Number of subjects in the intervention group who had significant adverse reactions 6. Mortality rates in both group. Timepoint: 3 months to collect data of patients # months to analyze the data | — |
Countries
India
Contacts
Public ContactNiranjan Waje
Sir H N Reliance Foundation Hospital and Research Centre
Outcome results
None listed