
PMC:7276972
Annnotations
LitCovid-PMC-OGER-BB
Id | Subject | Object | Predicate | Lexical cue |
---|---|---|---|---|
T1 | 29-35 | UBERON:0001969 | denotes | plasma |
T2 | 57-67 | SP_7 | denotes | SARS CoV-2 |
T3 | 77-85 | SP_7 | denotes | COVID-19 |
T4 | 206-212 | UBERON:0001969 | denotes | plasma |
T5 | 231-236 | UBERON:0007023 | denotes | adult |
T6 | 259-263 | UBERON:0000104 | denotes | life |
T7 | 276-284 | SP_7 | denotes | COVID-19 |
T8 | 305-309 | UBERON:0007221 | denotes | care |
T9 | 377-381 | UBERON:0000104 | denotes | life |
T10 | 394-402 | SP_7 | denotes | COVID-19 |
T11 | 563-579 | PR:000000017 | denotes | interferon-gamma |
T12 | 584-611 | PR:000000134 | denotes | tumor necrosis factor-alpha |
T13 | 689-697 | SP_7 | denotes | COVID-19 |
T14 | 874-883 | CL:0002211 | denotes | intensive |
T15 | 884-888 | UBERON:0007221;CL:0002486 | denotes | care |
T16 | 889-893 | CL:0002486 | denotes | unit |
T17 | 929-933 | UBERON:0000104 | denotes | life |
T18 | 946-954 | SP_7 | denotes | COVID-19 |
T19 | 1012-1022 | SP_7 | denotes | SARS-CoV-2 |
T20 | 1273-1279 | UBERON:0001969 | denotes | plasma |
T21 | 1315-1329 | CHEBI:53258;CHEBI:53258 | denotes | sodium citrate |
T22 | 1377-1387 | SP_7 | denotes | SARS-CoV-2 |
T23 | 1421-1429 | SP_7 | denotes | COVID-19 |
T24 | 1862-1870 | SP_7 | denotes | COVID-19 |
T25 | 2034-2040 | UBERON:0001969 | denotes | plasma |
T26 | 2066-2072 | UBERON:0001969 | denotes | plasma |
T27 | 2191-2195 | CHEBI:37527;CHEBI:37527 | denotes | acid |
T28 | 2241-2247 | UBERON:0002113 | denotes | Kidney |
T29 | 2307-2313 | UBERON:0001969 | denotes | Plasma |
T30 | 2358-2364 | UBERON:0001969 | denotes | plasma |
T31 | 2382-2394 | GO:0050817 | denotes | coagulopathy |
T32 | 2507-2517 | GO:0005577 | denotes | fibrinogen |
T33 | 2703-2711 | SP_7 | denotes | COVID-19 |
T34 | 2927-2931 | UBERON:0000104 | denotes | life |
T35 | 2944-2952 | SP_7 | denotes | COVID-19 |
T36 | 3121-3125 | CHEBI:33290;CHEBI:33290 | denotes | Food |
T37 | 3130-3134 | CHEBI:23888;CHEBI:23888 | denotes | Drug |
T38 | 3216-3221 | UBERON:0000062 | denotes | Organ |
T39 | 3294-3299 | UBERON:0001977 | denotes | serum |
T40 | 3300-3318 | PR:000005897 | denotes | C-reactive protein |
T41 | 3320-3327 | CHEBI:24996;CHEBI:24996 | denotes | lactate |
T42 | 3366-3379 | PR:000001393 | denotes | interleukin-6 |
T43 | 4240-4244 | UBERON:0000104 | denotes | life |
T44 | 4257-4265 | SP_7 | denotes | COVID-19 |
LitCovid-PD-FMA-UBERON
Id | Subject | Object | Predicate | Lexical cue | fma_id |
---|---|---|---|---|---|
T1 | 29-35 | Body_part | denotes | plasma | http://purl.org/sig/ont/fma/fma62970 |
T2 | 206-212 | Body_part | denotes | plasma | http://purl.org/sig/ont/fma/fma62970 |
T3 | 537-551 | Body_part | denotes | interleukins-3 | http://purl.org/sig/ont/fma/fma264832 |
T4 | 537-549 | Body_part | denotes | interleukins | http://purl.org/sig/ont/fma/fma86578 |
T5 | 637-645 | Body_part | denotes | cytokine | http://purl.org/sig/ont/fma/fma84050 |
T6 | 1273-1279 | Body_part | denotes | plasma | http://purl.org/sig/ont/fma/fma62970 |
T7 | 2034-2040 | Body_part | denotes | plasma | http://purl.org/sig/ont/fma/fma62970 |
T8 | 2066-2072 | Body_part | denotes | plasma | http://purl.org/sig/ont/fma/fma62970 |
T9 | 2241-2247 | Body_part | denotes | Kidney | http://purl.org/sig/ont/fma/fma7203 |
T10 | 2307-2313 | Body_part | denotes | Plasma | http://purl.org/sig/ont/fma/fma62970 |
T11 | 2358-2364 | Body_part | denotes | plasma | http://purl.org/sig/ont/fma/fma62970 |
T12 | 3216-3221 | Body_part | denotes | Organ | http://purl.org/sig/ont/fma/fma67498 |
T13 | 3294-3299 | Body_part | denotes | serum | http://purl.org/sig/ont/fma/fma63083 |
T14 | 3311-3318 | Body_part | denotes | protein | http://purl.org/sig/ont/fma/fma67257 |
T15 | 3366-3379 | Body_part | denotes | interleukin-6 | http://purl.org/sig/ont/fma/fma264829 |
LitCovid-PD-UBERON
Id | Subject | Object | Predicate | Lexical cue | uberon_id |
---|---|---|---|---|---|
T1 | 2241-2247 | Body_part | denotes | Kidney | http://purl.obolibrary.org/obo/UBERON_0002113 |
T2 | 3216-3221 | Body_part | denotes | Organ | http://purl.obolibrary.org/obo/UBERON_0000062 |
T3 | 3294-3299 | Body_part | denotes | serum | http://purl.obolibrary.org/obo/UBERON_0001977 |
LitCovid-PubTator
Id | Subject | Object | Predicate | Lexical cue | tao:has_database_id |
---|---|---|---|---|---|
2 | 57-75 | Disease | denotes | SARS CoV-2 disease | MESH:C000657245 |
3 | 77-85 | Disease | denotes | COVID-19 | MESH:C000657245 |
10 | 563-611 | Gene | denotes | interferon-gamma and tumor necrosis factor-alpha | Gene:3458 |
11 | 237-245 | Species | denotes | patients | Tax:9606 |
12 | 276-284 | Disease | denotes | COVID-19 | MESH:C000657245 |
13 | 354-363 | Disease | denotes | mortality | MESH:D003643 |
14 | 394-402 | Disease | denotes | COVID-19 | MESH:C000657245 |
15 | 689-697 | Disease | denotes | COVID-19 | MESH:C000657245 |
18 | 946-954 | Disease | denotes | COVID-19 | MESH:C000657245 |
19 | 1012-1032 | Disease | denotes | SARS-CoV-2 infection | MESH:C000657245 |
25 | 1377-1387 | Species | denotes | SARS-CoV-2 | Tax:2697049 |
26 | 1480-1488 | Species | denotes | patients | Tax:9606 |
27 | 1315-1329 | Chemical | denotes | sodium citrate | MESH:D000077559 |
28 | 1252-1269 | Disease | denotes | allergic reaction | MESH:D004342 |
29 | 1421-1429 | Disease | denotes | COVID-19 | MESH:C000657245 |
37 | 2507-2517 | Gene | denotes | fibrinogen | Gene:2244 |
38 | 2368-2376 | Species | denotes | patients | Tax:9606 |
39 | 2191-2212 | Chemical | denotes | acid-citrate dextrose | MESH:C002113 |
40 | 1862-1870 | Disease | denotes | COVID-19 | MESH:C000657245 |
41 | 2241-2255 | Disease | denotes | Kidney Disease | MESH:D007674 |
42 | 2382-2394 | Disease | denotes | coagulopathy | MESH:D001778 |
43 | 2703-2711 | Disease | denotes | COVID-19 | MESH:C000657245 |
48 | 3300-3318 | Gene | denotes | C-reactive protein | Gene:1401 |
49 | 3366-3379 | Gene | denotes | interleukin-6 | Gene:3569 |
50 | 2881-2890 | Disease | denotes | mortality | MESH:D003643 |
51 | 2944-2952 | Disease | denotes | COVID-19 | MESH:C000657245 |
55 | 3474-3482 | Species | denotes | patients | Tax:9606 |
56 | 3666-3674 | Species | denotes | patients | Tax:9606 |
57 | 3746-3754 | Species | denotes | patients | Tax:9606 |
63 | 4211-4219 | Species | denotes | patients | Tax:9606 |
64 | 4290-4298 | Species | denotes | patients | Tax:9606 |
65 | 4416-4424 | Species | denotes | patients | Tax:9606 |
66 | 4489-4501 | Species | denotes | participants | Tax:9606 |
67 | 4257-4265 | Disease | denotes | COVID-19 | MESH:C000657245 |
LitCovid-PD-MONDO
Id | Subject | Object | Predicate | Lexical cue | mondo_id |
---|---|---|---|---|---|
T1 | 57-61 | Disease | denotes | SARS | http://purl.obolibrary.org/obo/MONDO_0005091 |
T2 | 77-85 | Disease | denotes | COVID-19 | http://purl.obolibrary.org/obo/MONDO_0100096 |
T3 | 276-284 | Disease | denotes | COVID-19 | http://purl.obolibrary.org/obo/MONDO_0100096 |
T4 | 394-402 | Disease | denotes | COVID-19 | http://purl.obolibrary.org/obo/MONDO_0100096 |
T5 | 584-589 | Disease | denotes | tumor | http://purl.obolibrary.org/obo/MONDO_0005070 |
T6 | 689-697 | Disease | denotes | COVID-19 | http://purl.obolibrary.org/obo/MONDO_0100096 |
T7 | 946-954 | Disease | denotes | COVID-19 | http://purl.obolibrary.org/obo/MONDO_0100096 |
T8 | 1012-1020 | Disease | denotes | SARS-CoV | http://purl.obolibrary.org/obo/MONDO_0005091 |
T9 | 1023-1032 | Disease | denotes | infection | http://purl.obolibrary.org/obo/MONDO_0005550 |
T10 | 1252-1269 | Disease | denotes | allergic reaction | http://purl.obolibrary.org/obo/MONDO_0000605|http://purl.obolibrary.org/obo/MONDO_0005271 |
T12 | 1252-1260 | Disease | denotes | allergic | http://purl.obolibrary.org/obo/MONDO_0004980 |
T13 | 1377-1385 | Disease | denotes | SARS-CoV | http://purl.obolibrary.org/obo/MONDO_0005091 |
T14 | 1421-1429 | Disease | denotes | COVID-19 | http://purl.obolibrary.org/obo/MONDO_0100096 |
T15 | 1862-1870 | Disease | denotes | COVID-19 | http://purl.obolibrary.org/obo/MONDO_0100096 |
T16 | 2241-2255 | Disease | denotes | Kidney Disease | http://purl.obolibrary.org/obo/MONDO_0001343|http://purl.obolibrary.org/obo/MONDO_0005240 |
T18 | 2382-2394 | Disease | denotes | coagulopathy | http://purl.obolibrary.org/obo/MONDO_0001531 |
T19 | 2703-2711 | Disease | denotes | COVID-19 | http://purl.obolibrary.org/obo/MONDO_0100096 |
T20 | 2944-2952 | Disease | denotes | COVID-19 | http://purl.obolibrary.org/obo/MONDO_0100096 |
T21 | 4257-4265 | Disease | denotes | COVID-19 | http://purl.obolibrary.org/obo/MONDO_0100096 |
LitCovid-PD-CLO
Id | Subject | Object | Predicate | Lexical cue |
---|---|---|---|---|
T1 | 0-1 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | A |
T2 | 29-35 | http://purl.obolibrary.org/obo/UBERON_0001969 | denotes | plasma |
T3 | 88-89 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | A |
T4 | 112-113 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T5 | 157-167 | http://purl.obolibrary.org/obo/BFO_0000030 | denotes | Objectives |
T6 | 206-212 | http://purl.obolibrary.org/obo/UBERON_0001969 | denotes | plasma |
T7 | 537-551 | http://purl.obolibrary.org/obo/PR_000001387 | denotes | interleukins-3 |
T8 | 563-579 | http://purl.obolibrary.org/obo/PR_000000017 | denotes | interferon-gamma |
T9 | 584-611 | http://purl.obolibrary.org/obo/PR_000000134 | denotes | tumor necrosis factor-alpha |
T10 | 748-753 | http://purl.obolibrary.org/obo/CLO_0007225 | denotes | label |
T11 | 842-844 | http://purl.obolibrary.org/obo/CLO_0050510 | denotes | 18 |
T12 | 1147-1148 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T13 | 1273-1279 | http://purl.obolibrary.org/obo/UBERON_0001969 | denotes | plasma |
T14 | 1367-1372 | http://purl.obolibrary.org/obo/UBERON_0000473 | denotes | tests |
T15 | 2034-2040 | http://purl.obolibrary.org/obo/UBERON_0001969 | denotes | plasma |
T16 | 2066-2072 | http://purl.obolibrary.org/obo/UBERON_0001969 | denotes | plasma |
T17 | 2241-2247 | http://purl.obolibrary.org/obo/UBERON_0002113 | denotes | Kidney |
T18 | 2241-2247 | http://www.ebi.ac.uk/efo/EFO_0000927 | denotes | Kidney |
T19 | 2241-2247 | http://www.ebi.ac.uk/efo/EFO_0000929 | denotes | Kidney |
T20 | 2307-2313 | http://purl.obolibrary.org/obo/UBERON_0001969 | denotes | Plasma |
T21 | 2358-2364 | http://purl.obolibrary.org/obo/UBERON_0001969 | denotes | plasma |
T22 | 2396-2407 | http://purl.obolibrary.org/obo/PR_000007299 | denotes | prothrombin |
T23 | 2461-2470 | http://purl.obolibrary.org/obo/CLO_0001658 | denotes | activated |
T24 | 3216-3221 | http://purl.obolibrary.org/obo/UBERON_0003103 | denotes | Organ |
T25 | 3366-3379 | http://purl.obolibrary.org/obo/PR_000001393 | denotes | interleukin-6 |
T26 | 3499-3502 | http://purl.obolibrary.org/obo/CLO_0053733 | denotes | 1:1 |
T27 | 3676-3677 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | A |
T28 | 4187-4188 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T29 | 4444-4447 | http://purl.obolibrary.org/obo/CLO_0001577 | denotes | a 3 |
T30 | 4474-4475 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T31 | 4694-4696 | http://purl.obolibrary.org/obo/CLO_0050510 | denotes | 18 |
T32 | 4961-4964 | http://purl.obolibrary.org/obo/CLO_0051582 | denotes | has |
T33 | 5004-5005 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
LitCovid-PD-CHEBI
Id | Subject | Object | Predicate | Lexical cue | chebi_id |
---|---|---|---|---|---|
T1 | 537-549 | Chemical | denotes | interleukins | http://purl.obolibrary.org/obo/CHEBI_52998 |
T2 | 563-573 | Chemical | denotes | interferon | http://purl.obolibrary.org/obo/CHEBI_52999 |
T3 | 574-579 | Chemical | denotes | gamma | http://purl.obolibrary.org/obo/CHEBI_30212 |
T4 | 606-611 | Chemical | denotes | alpha | http://purl.obolibrary.org/obo/CHEBI_30216 |
T5 | 748-753 | Chemical | denotes | label | http://purl.obolibrary.org/obo/CHEBI_35209 |
T6 | 1149-1154 | Chemical | denotes | Light | http://purl.obolibrary.org/obo/CHEBI_30212 |
T7 | 1315-1329 | Chemical | denotes | sodium citrate | http://purl.obolibrary.org/obo/CHEBI_53258 |
T8 | 1315-1321 | Chemical | denotes | sodium | http://purl.obolibrary.org/obo/CHEBI_26708 |
T9 | 1322-1329 | Chemical | denotes | citrate | http://purl.obolibrary.org/obo/CHEBI_133748|http://purl.obolibrary.org/obo/CHEBI_16947|http://purl.obolibrary.org/obo/CHEBI_50744 |
T12 | 1811-1816 | Chemical | denotes | group | http://purl.obolibrary.org/obo/CHEBI_24433 |
T13 | 1916-1918 | Chemical | denotes | TM | http://purl.obolibrary.org/obo/CHEBI_55460|http://purl.obolibrary.org/obo/CHEBI_74861 |
T15 | 2157-2159 | Chemical | denotes | TM | http://purl.obolibrary.org/obo/CHEBI_55460|http://purl.obolibrary.org/obo/CHEBI_74861 |
T17 | 2191-2195 | Chemical | denotes | acid | http://purl.obolibrary.org/obo/CHEBI_37527 |
T18 | 2196-2203 | Chemical | denotes | citrate | http://purl.obolibrary.org/obo/CHEBI_133748|http://purl.obolibrary.org/obo/CHEBI_16947|http://purl.obolibrary.org/obo/CHEBI_50744 |
T21 | 2204-2212 | Chemical | denotes | dextrose | http://purl.obolibrary.org/obo/CHEBI_17634 |
T22 | 2213-2226 | Chemical | denotes | anticoagulant | http://purl.obolibrary.org/obo/CHEBI_50249 |
T23 | 3311-3318 | Chemical | denotes | protein | http://purl.obolibrary.org/obo/CHEBI_36080 |
T24 | 3320-3327 | Chemical | denotes | lactate | http://purl.obolibrary.org/obo/CHEBI_24996 |
T25 | 4328-4333 | Chemical | denotes | group | http://purl.obolibrary.org/obo/CHEBI_24433 |
T26 | 4433-4438 | Chemical | denotes | group | http://purl.obolibrary.org/obo/CHEBI_24433 |
LitCovid-PD-HP
Id | Subject | Object | Predicate | Lexical cue | hp_id |
---|---|---|---|---|---|
T1 | 584-589 | Phenotype | denotes | tumor | http://purl.obolibrary.org/obo/HP_0002664 |
T2 | 637-662 | Phenotype | denotes | cytokine release syndrome | http://purl.obolibrary.org/obo/HP_0033041 |
T3 | 2241-2255 | Phenotype | denotes | Kidney Disease | http://purl.obolibrary.org/obo/HP_0000112 |
T4 | 2382-2394 | Phenotype | denotes | coagulopathy | http://purl.obolibrary.org/obo/HP_0003256 |
LitCovid-PD-GO-BP
Id | Subject | Object | Predicate | Lexical cue |
---|---|---|---|---|
T1 | 36-44 | http://purl.obolibrary.org/obo/GO_0015297 | denotes | exchange |
T2 | 213-221 | http://purl.obolibrary.org/obo/GO_0015297 | denotes | exchange |
T3 | 590-598 | http://purl.obolibrary.org/obo/GO_0070265 | denotes | necrosis |
T4 | 590-598 | http://purl.obolibrary.org/obo/GO_0019835 | denotes | necrosis |
T5 | 590-598 | http://purl.obolibrary.org/obo/GO_0008219 | denotes | necrosis |
T6 | 590-598 | http://purl.obolibrary.org/obo/GO_0001906 | denotes | necrosis |
T7 | 1280-1291 | http://purl.obolibrary.org/obo/GO_0015297 | denotes | exchange or |
LitCovid-sentences
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. |