A multi-centric, comparative, randomized, double-blind, placebo-controlled, Phase 3 trial to evaluate the efficacy and safety of Intravenous Aviptadil, as an add-on to the Ã¢â?¬Å?Standard of CareÃ¢â?¬? in severe COVID-19 patients with respiratory failure.

Zuventus Healthcare Limited0 个研究点目标入组 150 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•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

•1.Age <18 years
•2.Mechanical ventilation for more than 7 days.
•3.Mean Arterial Pressure < 65 mm Hg with use of pressor per ICU protocol
•4.Irreversible condition (other than COVID-19) with projected fatal course
•5.Requirement of Extracorporeal membrane oxygenation (ECMO)
•6.Current or recent (within 30 d) enrolment in another investigational trial of anti-IL6 drug;
•7.Active diagnosis of Acquired immune deficiency syndrome;
•8.Transplant patients currently immunosuppressed;
•9.Chemotherapy-induced neutropenia (granulocyte count <1000/mm3);
•10.Cardiogenic shock; congestive heart failure - NYHA Class 3 or 4;
•11.Recent myocardial infarction - within last 6 months and troponin > 0.5
•12.Anuria (urine output < 50 ml/d) or other signs of multi-organ failure
•13.Severe liver disease with portal hypertension;
•14.Recent stroke or head trauma within last 12 months
•15.Increased intracranial pressure, or other serious neurologic disorder;
•16.Liquid diarrhea more than 3/day; defined as more than 3 non-bloody watery stools within a 24-hour period, requiring additional fluid and electrolyte supplementation
•17.Pregnant or lactating women

发起方