Intravenous L-Citrulline to Delay and Potentially Prevent the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failure in Patients With COVID-19 (SARS-CoV-2) Illness

• Status: Recruiting
• Trial end date: 2021-10-30
• Target enrollment: 0
• Participant gender: All

Summary

Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous L-Citrulline (Turnobi) to Delay and Potentially Prevent the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failure in Patients with COVID-19 (SARS-CoV2) Illness. To evaluate safety and efficacy of a bolus loading dose and continuous intravenous infusion of L-Citrulline compared to placebo in patients hospitalized with COVID-19 infection (SARS-CoV-2).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asklepion Pharmaceuticals, LLC

Criteria

Inclusion Criteria:

1. Age 18-65 years.

2. 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.

3. Admitted and transferred to floor without intubation.

Exclusion Criteria:

1. No consent/inability to obtain consent

2. Patient, surrogate, or physician not committed to full support

3. Malignant or other irreversible condition and estimated 28-day mortality ≥ 50%

4. Moribund patient not expected to survive 48 hours (as defined by primary medical team) from start of study infusion

5. End-stage Liver Disease as defined by Child-Pugh Score > 9

6. Currently enrolled in, or participated in another study of an investigational compound within the last 30 days

7. Pregnant female, or female who is breast feeding

8. Allergy to L-citrulline or arginine or any citrulline- or arginine-containing product

9. Patient not otherwise suitable for the study in the opinion of any of the investigators

10. Requirement for intubation and invasive mechanical ventilation before study enrollment