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PMC:7276972 JSONTXT 17 Projects

Annnotations TAB TSV DIC JSON TextAE Lectin_function IAV-Glycan

Id Subject Object Predicate Lexical cue
T1 0-87 Sentence denotes A pilot study of therapeutic plasma exchange for serious SARS CoV-2 disease (COVID-19):
T2 88-156 Sentence denotes A structured summary of a randomized controlled trial study protocol
T3 157-167 Sentence denotes Objectives
T4 168-364 Sentence denotes To evaluate the safety of therapeutic plasma exchange (TPE) in adult patients with serious/life-threatening COVID-19 requiring intensive care unit (ICU) admission, and associated 28-day mortality.
T5 365-499 Sentence denotes Serious and life threatening COVID-19 are defined as per published literature (please, refer to the full protocol, Additional file 1).
T6 500-612 Sentence denotes The rationale is that TPE can remove interleukins-3, 6, 8, 10, interferon-gamma and tumor necrosis factor-alpha.
T7 613-706 Sentence denotes Thus, it may reduce the cytokine release syndrome associated with fulminant COVID-19 disease.
T8 707-719 Sentence denotes Trial design
T9 720-795 Sentence denotes Pilot, interventional, open-label, randomized controlled multicenter trial.
T10 796-808 Sentence denotes Participants
T11 809-832 Sentence denotes Inclusion criteria are:
T12 833-1011 Sentence denotes 1) age ≥ 18 years old; 2) intubation and intensive care unit (ICU) admission; 3) serious and/or life-threatening COVID-19 (please, refer to the full protocol, Additional file 1).
T13 1012-1215 Sentence denotes SARS-CoV-2 infection is confirmed by Real-Time-Polymerase-Chain-Reaction (RT-PCR) assays using QuantiNova Probe RT-PCR kit (Qiagen) in a Light-Cycler 480 real-time PCR system (Roche, Basel, Switzerland).
T14 1216-1239 Sentence denotes Exclusion criteria are:
T15 1240-1515 Sentence denotes 1) previous allergic reaction to plasma exchange or its ingredients (i.e., sodium citrate), 2) two consecutive negative RT-PCR tests for SARS-CoV-2 at least 24 hours apart, 3) mild COVID-19 not requiring ICU admission and 4) terminally ill patients receiving palliative care.
T16 1516-1610 Sentence denotes The primary site will be King Saud Medical City (KSMC), Riyadh, Kingdom of Saudi Arabia (KSA).
T17 1611-1764 Sentence denotes Also, the study will run in ICUs (Ministry of Health Cluster 1; Riyadh) and other centers in KSA pending their institutional review board (IRB) approval.
T18 1765-1793 Sentence denotes Interventions and comparator
T19 1794-1871 Sentence denotes The intervention group will receive TPE, plus empiric treatment for COVID-19.
T20 1872-2011 Sentence denotes TPE is administered using the Spectra Optia TM Apheresis System equipped with the Depuro D2000 Adsorption Cartridge (Terumo BCT Inc., USA).
T21 2012-2142 Sentence denotes The first dose is 1.5 plasma volumes, followed by one plasma volume on alternate days or daily for five to seven total treatments.
T22 2143-2306 Sentence denotes Spectra Optia TM Apheresis System operates with acid-citrate dextrose anticoagulant (ACDA) as per Kidney Disease Improving Global Outcomes (KDIGO) 2019 guidelines.
T23 2307-2535 Sentence denotes Plasma is replaced with albumin 5% or fresh frozen plasma in patients with coagulopathy (prothrombin time >37 seconds; international normalized ratio >3; activated partial thromboplastin time >100 or fibrinogen level <100 mg/d).
T24 2536-2623 Sentence denotes TPE sessions are performed daily over four hours and laboratory markers measured daily.
T25 2624-2777 Sentence denotes The comparators are controls not receiving TPE but usual empiric treatment for COVID-19 as per institutional, national and international recommendations.
T26 2778-2832 Sentence denotes Both groups will receive standard ICU supportive care.
T27 2833-2846 Sentence denotes Main outcomes
T28 2847-2953 Sentence denotes Primary study end-point is 28-day mortality and safety of TPE in serious and/or life-threatening COVID-19.
T29 2954-3162 Sentence denotes Safety will be evaluated by the documentation of any pertinent adverse and/or serious adverse effects related to TPE as per institutional, national and international (Food and Drug Administration) guidelines.
T30 3163-3440 Sentence denotes Secondary outcomes are: i) improvement in Sequential Organ Function Assessment (SOFA) score ; ii) changes in inflammatory markers: serum C-reactive protein, lactate dehydrogenase, ferritin, d-dimers and interleukin-6; iii) days on mechanical ventilation and ICU length of stay.
T31 3441-3454 Sentence denotes Randomization
T32 3455-3603 Sentence denotes Eligible consented patients are randomized (1:1 allocation) after stratification by ICU center and two PaO2/FIO2 ratio categories (> 150 and ≤ 150).
T33 3604-3675 Sentence denotes Randomization occurs in variable block sizes of four to eight patients.
T34 3676-3827 Sentence denotes A web-based randomization service, randomize.net, is used to allocate patients to their respective strata prior to the intervention or control therapy.
T35 3828-3846 Sentence denotes Blinding (masking)
T36 3847-3973 Sentence denotes Given the visibility of TPE machinery, the intervention will be unblinded; hence, no enrollment concealment will be expedited.
T37 3974-4103 Sentence denotes The lack of allocation concealment will be mitigated by several measures (please, refer to the full protocol, Additional file 1).
T38 4104-4142 Sentence denotes Numbers to be randomized (sample size)
T39 4143-4266 Sentence denotes This pilot randomized trial aims to recruit a convenience sample of patients with serious and/or life-threatening COVID-19.
T40 4267-4359 Sentence denotes Therefore, at least 20 patients are to be randomized to each group per participating center.
T41 4360-4502 Sentence denotes We are hoping to consent and randomize approximately 60 patients in each group over a 3 to 6 months period giving a total of 120 participants.
T42 4503-4515 Sentence denotes Trial Status
T43 4516-4563 Sentence denotes The protocol version 1 was approved 29/04/2020.
T44 4564-4612 Sentence denotes Recruitment is ongoing, and began on 01/05/2020.
T45 4613-4650 Sentence denotes We estimate completion by 29/10/2020.
T46 4651-4669 Sentence denotes Trial registration
T47 4670-4751 Sentence denotes Registered at ISRCTN on 18/05/2020 (ISRCTN21363594; doi.10.1186/ ISRCTN21363594).
T48 4752-4765 Sentence denotes Full protocol
T49 4766-4874 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T50 4875-5055 Sentence denotes In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.