A clinical trial of Intravenous Aviptadil along with standard treatment in severe COVID-19 Patients with respiratory failure.

INTERVENTION: Intervention1: Aviptadil 150mcg with Standard of Care: Patients will be treated with 12‐hour infusions of Aviptadil at ascending doses on 3 successive days. Patients will receive 0.166 mcg/kg/hr on Day 1, 0.332 mcg/kg/hr on Day 2 and 0.498 mcg/kg/hr on Day 3. The Standard of Care will be as per individual Hospital protocol. It will be kept as close to the government treatment protocol as possible. Control Intervention1: Placebo with Standard of Care: Placebo will be used as the control and will be administered 12‐hour infusion 3 successive days. The Standard of Care will be as per individual Hospital protocol. It will be kept as close to the government treatment protocol as possible. CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: Resolution of Respiratory FailureTimepoint: Day 0 through Day 28 SECONDARY OUTCOME: Improvement in chest x‐rayTimepoint: Day 0, Day 7 and Day 28 Improvement in inflammatory markersTimepoint: Day 0 through Day 28 Improvement on WHO ordinal scaleTimepoint: Day 0 through Day 28 Multi‐organ failure free daysTimepoint: Day 0 through Day 28 Number of patients reporting incidences of adverse eventsTimepoint: Day 0 through Day 14 Respiratory Distress (PaO2:FiO2 ratio) while on mechanical ventilationTimepoint: Day 0 through Day 28 SurvivalTimepoint: Day 0 through Day 28 and Day 60 Time on ventilationTimepoint: Day 0 through Day 28 Time to discharge aliveTimepoint: Day 0 through Day 28 Time to extubationTimepoint: Day 0 through Day 28 Time to ICU dischargeTimepoint: Day 0 through Day 28 INCLUSION CRITERIA: 1. Severe COVID‐19 with respiratory failure 2. Physician determination that patient is on maximal conventional medical therapy 3. Without Mechanical ventilation or with mechanical ventilation < 7 days