Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: L-Arginine: 1.66gm twice a day for 10 days or till end of hospitalisation whichever is earlier
Control Intervention1: Glucose: 1.66gm twice a day for 10 days or till end of hospitalisat
Sponsors
Clinical Research Centre Dept of Physiology
Eligibility
Inclusion criteria
Inclusion criteria: Age�18 years nonpregnant patients diagnosed as COVID positive (RAT or RTPCR positive) Oxygen saturation while breathing on ambient room air less than 93% or on already on supplemental oxygen as determined by pulse oximetry measurement or clinically Less than 15 days from symptom onset for COVID-19 Willing to take arginine/placebo as the intervention for ten days and will provide written informed consent
Exclusion criteria
Exclusion criteria: Refusal to give consent Unable to take intervention orally for ten days CKD patients on hemodialysis or requiring fluid restriction as part of their management Patient on inotropic support at admission Patients requiring BIPAP (NIV) for an indication other than COVID-19 infection prior to admission Patients will be excluded if progression of the illness to death was imminent and inevitable within 24 hours, as determined by the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ordinal score in patients on arginine versus placebo. Proposed Ordinal Score: Category Clinical status Notes 1 Discharged/Ready for discharge with no symptoms, stable oxygen saturation on ambient air 2 Ready for discharge with no symptoms, stable oxygen saturation on nasal prongs 2L of oxygen 3 Hospitalised, on supplemental oxygen via Nasal prongs or Face mask 4 Hospitalised, on supplemental oxygen via Non rebreathing mask 5 Hospitalised, on NIV or HFNC 6 On mechanical ventilation 7 On mechanical ventilation and inotropes/HD 8 Dead Timepoint: Daily assessment over 10 days | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Duration of hospital stay ââ?¬Â¢ Adverse event (thrombotic) frequency ââ?¬Â¢ Number of Mechanical ventilation/HFNC or NIV days ââ?¬Â¢ Number of days it takes to get off oxygen ââ?¬Â¢ SpO2/FiO2 ratio at Day10 ââ?¬Â¢ Inflammatory marker normalisation ââ?¬Â¢ Mortality during hospital stay Timepoint: Daily assessment over 10 days | — |
Countries
India
Contacts
Public ContactJananee Muralidharan
St Johns Medical college
Outcome results
None listed