COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=64898

Jananee Muralidharan

jananee.m@stjohns.in

2022-01-19

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Ageâ?¥18 years nonpregnant patients diagnosed as COVID positive (RAT or RTPCR positive) <br/ > 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 <br/ > Less than 15 days from symptom onset for COVID-19 <br/ > Willing to take arginine/placebo as the intervention for ten days and will provide written informed consent <br/ >

Refusal to give consent <br/ > Unable to take intervention orally for ten days <br/ > CKD patients on hemodialysis or requiring fluid restriction as part of their management <br/ > Patient on inotropic support at admission <br/ > Patients requiring BIPAP (NIV) for an indication other than COVID-19 infection prior to admission <br/ > Patients will be excluded if progression of the illness to death was imminent and inevitable within 24 hours, as determined by the treating physician. <br/ >

2

Clinical Research Centre Dept of Physiology

18

99

India

Moderate disease at enrollment

3: Moderate disease at enrollment

202

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

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 714, "treatment_name": "L-arginine", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]