@article{Dushianthan:2020:10.1186/s13063-020-04944-5,
author = {Dushianthan, A and Clark, H and Madsen, J and Mogg, R and Matthews, L and Berry, L and Bernardino, de la Serna J and Batchelor, J and Brealey, D and Hussell, T and Porter, J and Djukanovic, R and Feelisch, M and Postle, A and Grocott, MPW},
doi = {10.1186/s13063-020-04944-5},
journal = {Trials},
pages = {1--3},
title = {Nebulised surfactant for the treatment of severe COVID-19 in adults (COV-Surf): A structured summary of a study protocol for a randomized controlled trial},
url = {http://dx.doi.org/10.1186/s13063-020-04944-5},
volume = {21},
year = {2020}
}

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TY  - JOUR
AB  - Intervention and comparator: Intervention: The study is based on an investigational drug/device combinationproduct. The surfactant product is Bovactant (Alveofact®), a natural animal derived (bovine) lung surfactantformulated as a lyophilized powder in 108 mg vials and reconstituted to 45 mg/mL in buffer supplied in a prefilledsyringe. It is isolated by lung lavage and, by weight, is a mixture of: phospholipid (75% phosphatidylcholine, 13%phosphatidylglycerol, 3% phosphatidylethanolamine, 1% phosphatidylinositol and 1% sphingomyelin), 5%cholesterol, 1% lipid-soluble surfactant-associated proteins (SP-B and SP-C), very low levels of free fatty acid, lysophosphatidylcholine, water and 0.3% calcium. The Drug Delivery Device is the AeroFact-COVID™ nebulizer, aninvestigational device based on the Aerogen® Solo vibrating mesh nebulizer.The timing and escalation dosing plans for the surfactant are as follows.Cohort 1: Three patients will receive 10 vials (1080 mg) each of surfactant at dosing times of 0 hours, 8 hours and24 hours. 2 controls with no placebo intervention.Cohort 2: Three patients will receive 10 vials (1080 mg) of surfactant at dosing times of 0 hours and 8 hours, and30 vials (3240 mg) at a dosing time of 24 hours. 2 controls with no placebo intervention.Cohort 3: Three patients will receive 10 vials (1080 mg) of surfactant at a dosing time of 0 hours, and 30 vials (3240mg) at dosing times of 8 hours and 24 hours. 2 controls with no placebo intervention.Cohort 4: Three patients will receive 30 (3240 mg) vials each of surfactant at dosing times of 0 hours, 8 hours and24 hours. 2 controls. 2 controls with no placebo intervention.The trial steering committee, advised by the data monitoring committee, will review trial progression and doseescalation/maintenance/reduction after each cohort is completed (48-hour primary outcome timepoint reached)based on available feasibility, adverse event, safety and efficacy data. The trial will not be discontinue
AU  - Dushianthan,A
AU  - Clark,H
AU  - Madsen,J
AU  - Mogg,R
AU  - Matthews,L
AU  - Berry,L
AU  - Bernardino,de la Serna J
AU  - Batchelor,J
AU  - Brealey,D
AU  - Hussell,T
AU  - Porter,J
AU  - Djukanovic,R
AU  - Feelisch,M
AU  - Postle,A
AU  - Grocott,MPW
DO  - 10.1186/s13063-020-04944-5
EP  - 3
PY  - 2020///
SN  - 1745-6215
SP  - 1
TI  - Nebulised surfactant for the treatment of severe COVID-19 in adults (COV-Surf): A structured summary of a study protocol for a randomized controlled trial
T2  - Trials
UR  - http://dx.doi.org/10.1186/s13063-020-04944-5
UR  - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04944-5
UR  - http://hdl.handle.net/10044/1/85164
VL  - 21
ER  - 

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