COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04570384

Gurdyal Kalsi, MD, MFPM

gurdyal.kalsi@asklepionpharm.com

2020-09-30

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: age 18-65 years. clinical evidence of covid-19 (sars-cov2) infection, defined as a positive covid-19 laboratory test plus evidence of an acute hypoxemic respiratory illness requiring oxygen. admitted and transferred to floor without intubation.

no consent/inability to obtain consent patient, surrogate, or physician not committed to full support malignant or other irreversible condition and estimated 28-day mortality ≥ 50% moribund patient not expected to survive 48 hours (as defined by primary medical team) from start of study infusion end-stage liver disease as defined by child-pugh score > 9 currently enrolled in, or participated in another study of an investigational compound within the last 30 days pregnant female, or female who is breast feeding allergy to l-citrulline or arginine or any citrulline- or arginine-containing product patient not otherwise suitable for the study in the opinion of any of the investigators requirement for intubation and invasive mechanical ventilation before study enrollment

2

Asklepion Pharmaceuticals, LLC

18

65

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

65

Diastolic Blood Pressure;Mean Arterial Pressure;Systolic Blood Pressure;Time to Invasive Mechanical Ventilation;Time to Non-invasive/Invasive Mechanical Ventilation;Time to Non-invasive Mechanical Ventilation

None

Phase 2

[{"arm_notes": "", "treatment_id": 721, "treatment_name": "L-citrulline", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]