Authors
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Monash Health -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2020
INTERVENTION: Cord blood therapy (expanded cord blood cells) + standard supportive management 5 million expanded umbilical cord blood cells (max ‐500 million cells) given intravenously over an hour by hospital staff under observation by research team Single administration sourced from off the shelf CB units CONDITION: COVID‐19;Pneumonia; ; COVID‐19 ; Pneumonia Infection ‐ Studies of infection and infectious agents Respiratory ‐ Other respiratory disorders / diseases PRIMARY OUTCOME: Clinical improvement, as documented by change of patient status on a seven‐category ordinal scale (to be completed by hospital staff or researcher); Seven‐category ordinal scale:; 1, not hospitalised with resumption of normal activities; 2, not hospitalised, but unable to resume normal activities; 3, hospitalised, not requiring supplemental oxygen; 4, hospitalised, requiring supplemental oxygen; 5, hospitalised, requiring humidified nasal high‐flow oxygen therapy, non‐invasive mechanical ventilation, or both; 6,hospitalised, requiring ECMO, invasive mechanical ventilation, ECMO or both; and 7, death.[ Assessed every day until resolution of symptoms or death] Safety and tolerability of UCB cell administration (absence of immediate and short‐term side effects, including allergic reactions, line related effects, infection); This will be assessed based on partipant rports, and hospital charts and monitoring[24 hrs (collection of hourly vital monitoring data, examination at 24 hrs)] SECONDARY OUTCOME: All cause mortality[30‐ day and 90‐day] Immune response (as assessed by blood samples taken)[1 week after UCB infusion/ control enrolment] Individual symptom resolution (as assessed by staff in hospital/ or by patient at home)[Assessed daily until resolution of individual symptom] Need and duration of mechanical ventilation (as assessed by hospital staff)[Assessed daily until time to cessation of ventilation] Secondary bacterial infection (as assessed by any cultures taken)[Assesed daily until hospital discharge] Time to clinical stability (need for hospitalisation as assesed by hospital staff)[Assessed daily until resolution of symptoms requiring hospitalisation] INCLUSION CRITERIA: Hospitalised patients with confirmed SARS‐CoV2 infection (based on appropriate nucleic acid or other testing), and 1) Expected to remain an in‐patient for at least 48 hours with 2) Features consistent with viral pneumonia on Chest CT or X‐Ray (in the opinion of the investigator) and 3) Are unable to maintain a peripheral oxygen saturation of 95% or greater in room air
Epistemonikos ID: b2006c1e842cda9a3029865f3234ae5b8fcceeca
First added on: Jun 22, 2020