Arginine in COVID-19 patients

Not Applicable

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2022/01/039549
• Lead Sponsor: Clinical Research Centre Dept of Physiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-02-24
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 74

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in ordinal score in patients on arginine versus placebo. <br/ ><br>Proposed Ordinal Score: <br/ ><br>CategoryClinical statusNotes <br/ ><br>1Discharged/Ready for discharge with no symptoms, stable oxygen saturation on ambient air <br/ ><br>2Ready for discharge with no symptoms, stable oxygen saturation on nasal prongs 2L of oxygen <br/ ><br>3Hospitalised, on supplemental oxygen via Nasal prongs or Face mask <br/ ><br>4Hospitalised, on supplemental oxygen via Non rebreathing mask <br/ ><br>5Hospitalised, on NIV or HFNC <br/ ><br>6On mechanical ventilation <br/ ><br>7On mechanical ventilation and inotropes/HD <br/ ><br>8Dead <br/ ><br> <br/ ><br>Timepoint: Daily assessment over 10 days <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
�Duration of hospital stay <br/ ><br>�Adverse event (thrombotic) frequency <br/ ><br>�Number of Mechanical ventilation/HFNC or NIV days <br/ ><br>�Number of days it takes to get off oxygen <br/ ><br>�SpO2/FiO2 ratio at Day10 <br/ ><br>�Inflammatory marker normalisation <br/ ><br>�Mortality during hospital stay <br/ ><br> <br/ ><br>Timepoint: Daily assessment over 10 days