Amnion cells for COVID-19 related respiratory failure

Phase 1

• Conditions: COVID-19 related respiratory failure; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12620000676910
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-15
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients included in this study must satisfy ALL of the following criteria:
•Proven or highly suspected COVID-19 through a polymerase chain reaction (PCR) test of a nasal swab; or a negative PCR test with typical radiological finding or CT scan in the absence of alternate diagnoses; or patients with respiratory failure of infective origin admitted to ICU during the COVID-19 pandemic
•Receiving supplemental oxygen, due to respiratory failure, with PaO2/FiO2 ratio less than or equal to 200 (moderate to severe) or an SaO2 < 92% while receiving more than or equal to 4 litres of O2 via face mask.

Exclusion Criteria

Patients will be excluded if they have ANY of the following:
•Less than 18 years old
•Have been intubated for more than 48 hours,
•Documented significant chronic obstructive airway disease
•Death is imminent and inevitable within 24 hours,
•Limitation of therapy includes no invasive mechanical ventilation,
•Severe global left ventricular dysfunction with an ejection fraction of <25%,
•Receiving extracorporeal support or is highly likely within the next 12 hours,
•Acute fulminant hepatitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ventilator free days score (VFD, composite of mortality and ventilator-free days) at 21 days after randomisation based on patient medical records[21 days after randomisation];daily change in P/F ratio based on patient medical records of ventilator settings[over the first 5 days following intervention]

Secondary Outcome Measures

Name	Time	Method
Sequential Organ Failure Assessment (SOFA) score [over 7-day period post intervention];ICU free survival based on patient medical records[day 21 post randomisation];Duration of mechanical ventilation in survivors based on patient medical records[hospital discharge or day 28];Intensive care unit length of stay based on patient medical records[hospital discharge or day 28, whichever comes first];Hospital length of stay based on patient medical records[hospital discharge or day 28, whichever comes first]