PubMed:32560744
Annnotations
LitCovid-OGER-BB
Id | Subject | Object | Predicate | Lexical cue |
---|---|---|---|---|
T1 | 187-195 | SP_7 | denotes | COVID-19 |
T2 | 860-866 | CHEBI:36357 | denotes | agents |
T3 | 860-866 | CHEBI:36357 | denotes | agents |
T4 | 888-896 | SP_7 | denotes | COVID-19 |
T5 | 1162-1172 | GO:0065007 | denotes | regulatory |
T6 | 1528-1533 | UBERON:0007023 | denotes | adult |
T7 | 1600-1647 | SP_7 | denotes | severe acute respiratory syndrome coronavirus 2 |
T8 | 1613-1624 | UBERON:0001004 | denotes | respiratory |
T9 | 1649-1659 | SP_7 | denotes | SARS-CoV-2 |
T10 | 1831-1839 | SP_7 | denotes | COVID-19 |
T11 | 1917-1922 | UBERON:0000004 | denotes | nasal |
T12 | 2099-2104 | UBERON:0000062 | denotes | organ |
T13 | 2199-2208 | UBERON:0001982 | denotes | capillary |
T14 | 2356-2366 | SP_7 | denotes | SARS-CoV-2 |
T15 | 2651-2656 | NCBITaxon:10239 | denotes | viral |
T16 | 2651-2668 | GO:0006260 | denotes | viral replication |
T17 | 2685-2690 | NCBITaxon:10239 | denotes | viral |
T18 | 3467-3472 | GO:0016265 | denotes | death |
T19 | 3501-3506 | NCBITaxon:10239 | denotes | viral |
T20 | 4318-4328 | GO:0065007 | denotes | regulatory |
LitCovid-PD-FMA-UBERON
Id | Subject | Object | Predicate | Lexical cue | fma_id |
---|---|---|---|---|---|
T1 | 690-693 | Body_part | denotes | arm | http://purl.org/sig/ont/fma/fma24890 |
T2 | 2099-2104 | Body_part | denotes | organ | http://purl.org/sig/ont/fma/fma67498 |
T3 | 2199-2208 | Body_part | denotes | capillary | http://purl.org/sig/ont/fma/fma63194 |
T4 | 2619-2627 | Body_part | denotes | cytokine | http://purl.org/sig/ont/fma/fma84050 |
LitCovid-PD-UBERON
Id | Subject | Object | Predicate | Lexical cue | uberon_id |
---|---|---|---|---|---|
T1 | 690-693 | Body_part | denotes | arm | http://purl.obolibrary.org/obo/UBERON_0001460 |
T2 | 1866-1871 | Body_part | denotes | scale | http://purl.obolibrary.org/obo/UBERON_0002542 |
T3 | 2099-2104 | Body_part | denotes | organ | http://purl.obolibrary.org/obo/UBERON_0000062 |
T4 | 2199-2208 | Body_part | denotes | capillary | http://purl.obolibrary.org/obo/UBERON_0001982 |
T5 | 3339-3344 | Body_part | denotes | scale | http://purl.obolibrary.org/obo/UBERON_0002542 |
LitCovid-PD-MONDO
Id | Subject | Object | Predicate | Lexical cue | mondo_id |
---|---|---|---|---|---|
T1 | 187-195 | Disease | denotes | COVID-19 | http://purl.obolibrary.org/obo/MONDO_0100096 |
T2 | 888-896 | Disease | denotes | COVID-19 | http://purl.obolibrary.org/obo/MONDO_0100096 |
T3 | 1585-1594 | Disease | denotes | infection | http://purl.obolibrary.org/obo/MONDO_0005550 |
T4 | 1600-1647 | Disease | denotes | severe acute respiratory syndrome coronavirus 2 | http://purl.obolibrary.org/obo/MONDO_0100096 |
T5 | 1600-1633 | Disease | denotes | severe acute respiratory syndrome | http://purl.obolibrary.org/obo/MONDO_0005091 |
T6 | 1649-1657 | Disease | denotes | SARS-CoV | http://purl.obolibrary.org/obo/MONDO_0005091 |
T7 | 1831-1839 | Disease | denotes | COVID-19 | http://purl.obolibrary.org/obo/MONDO_0100096 |
T8 | 1840-1849 | Disease | denotes | infection | http://purl.obolibrary.org/obo/MONDO_0005550 |
T9 | 2239-2241 | Disease | denotes | RA | http://purl.obolibrary.org/obo/MONDO_0005272|http://purl.obolibrary.org/obo/MONDO_0008383 |
T11 | 2356-2364 | Disease | denotes | SARS-CoV | http://purl.obolibrary.org/obo/MONDO_0005091 |
T12 | 2367-2376 | Disease | denotes | infection | http://purl.obolibrary.org/obo/MONDO_0005550 |
LitCovid-PD-CLO
Id | Subject | Object | Predicate | Lexical cue |
---|---|---|---|---|
T1 | 14-15 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | A |
T2 | 197-198 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | A |
T3 | 221-222 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T4 | 242-243 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T5 | 271-281 | http://purl.obolibrary.org/obo/BFO_0000030 | denotes | OBJECTIVES |
T6 | 596-597 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T7 | 660-661 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T8 | 690-693 | http://www.ebi.ac.uk/efo/EFO_0001410 | denotes | arm |
T9 | 724-729 | http://purl.obolibrary.org/obo/CLO_0007225 | denotes | label |
T10 | 818-826 | http://purl.obolibrary.org/obo/CLO_0001658 | denotes | activity |
T11 | 910-911 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T12 | 1145-1148 | http://purl.obolibrary.org/obo/CLO_0051582 | denotes | has |
T13 | 1323-1324 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T14 | 1339-1342 | http://purl.obolibrary.org/obo/CLO_0051582 | denotes | has |
T15 | 1412-1413 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T16 | 1545-1547 | http://purl.obolibrary.org/obo/CLO_0050510 | denotes | 18 |
T17 | 1743-1744 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | A |
T18 | 2099-2104 | http://purl.obolibrary.org/obo/UBERON_0003103 | denotes | organ |
T19 | 2121-2122 | http://purl.obolibrary.org/obo/CLO_0001021 | denotes | B |
T20 | 2235-2237 | http://purl.obolibrary.org/obo/CLO_0001527 | denotes | 94 |
T21 | 2831-2832 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T22 | 3150-3151 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T23 | 3433-3437 | http://purl.obolibrary.org/obo/CLO_0008947 | denotes | SaO2 |
T24 | 3433-3437 | http://purl.obolibrary.org/obo/CLO_0050140 | denotes | SaO2 |
T25 | 3723-3728 | http://purl.obolibrary.org/obo/CLO_0007225 | denotes | label |
T26 | 3973-3974 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T27 | 3988-3989 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T28 | 4210-4211 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
T29 | 4359-4366 | http://www.ebi.ac.uk/efo/EFO_0000881 | denotes | digital |
T30 | 4673-4675 | http://purl.obolibrary.org/obo/CLO_0050509 | denotes | 27 |
T31 | 4902-4905 | http://purl.obolibrary.org/obo/CLO_0051582 | denotes | has |
T32 | 4945-4946 | http://purl.obolibrary.org/obo/CLO_0001020 | denotes | a |
LitCovid-PD-CHEBI
Id | Subject | Object | Predicate | Lexical cue | chebi_id |
---|---|---|---|---|---|
T1 | 68-70 | Chemical | denotes | II | http://purl.obolibrary.org/obo/CHEBI_74067 |
T2 | 405-407 | Chemical | denotes | II | http://purl.obolibrary.org/obo/CHEBI_74067 |
T3 | 610-612 | Chemical | denotes | II | http://purl.obolibrary.org/obo/CHEBI_74067 |
T4 | 724-729 | Chemical | denotes | label | http://purl.obolibrary.org/obo/CHEBI_35209 |
T5 | 758-760 | Chemical | denotes | II | http://purl.obolibrary.org/obo/CHEBI_74067 |
T6 | 1331-1333 | Chemical | denotes | II | http://purl.obolibrary.org/obo/CHEBI_74067 |
T7 | 1899-1905 | Chemical | denotes | oxygen | http://purl.obolibrary.org/obo/CHEBI_25805 |
T8 | 1987-1993 | Chemical | denotes | oxygen | http://purl.obolibrary.org/obo/CHEBI_25805 |
T9 | 2209-2215 | Chemical | denotes | oxygen | http://purl.obolibrary.org/obo/CHEBI_25805 |
T10 | 2239-2241 | Chemical | denotes | RA | http://purl.obolibrary.org/obo/CHEBI_73810 |
T11 | 3136-3138 | Chemical | denotes | II | http://purl.obolibrary.org/obo/CHEBI_74067 |
T12 | 3414-3420 | Chemical | denotes | oxygen | http://purl.obolibrary.org/obo/CHEBI_25805 |
T13 | 3723-3728 | Chemical | denotes | label | http://purl.obolibrary.org/obo/CHEBI_35209 |
T14 | 4415-4418 | Chemical | denotes | EDC | http://purl.obolibrary.org/obo/CHEBI_27789 |
T15 | 4928-4934 | Chemical | denotes | Letter | http://purl.obolibrary.org/obo/CHEBI_6446 |
LitCovid-PD-GO-BP
Id | Subject | Object | Predicate | Lexical cue |
---|---|---|---|---|
T1 | 2651-2668 | http://purl.obolibrary.org/obo/GO_0019079 | denotes | viral replication |
T2 | 2651-2668 | http://purl.obolibrary.org/obo/GO_0019058 | denotes | viral replication |
LitCovid-sentences
Id | Subject | Object | Predicate | Lexical cue |
---|---|---|---|---|
T1 | 0-13 | Sentence | denotes | AGILE-ACCORD: |
T2 | 14-196 | Sentence | denotes | A Randomized, Multicentre, Seamless, Adaptive Phase I/II Platform Study to Determine the Optimal Dose, Safety and Efficacy of Multiple Candidate Agents for the Treatment of COVID-19: |
T3 | 197-270 | Sentence | denotes | A structured summary of a study protocol for a randomised platform trial. |
T4 | 271-282 | Sentence | denotes | OBJECTIVES: |
T5 | 283-398 | Sentence | denotes | Phase I - To determine the optimal dose of each candidate (or combination of candidates) entered into the platform. |
T6 | 399-629 | Sentence | denotes | Phase II - To determine the efficacy and safety of each candidate entered into the platform, compared to the current Standard of Care (SoC), and recommend whether it should be evaluated further in a later phase II & III platforms. |
T7 | 630-897 | Sentence | denotes | TRIAL DESIGN: AGILE-ACCORD is a Bayesian multicentre, multi-arm, multi-dose, multi-stage open-label, adaptive, seamless phase I/II randomised platform trial to determine the optimal dose, activity and safety of multiple candidate agents for the treatment of COVID-19. |
T8 | 898-1240 | Sentence | denotes | Designed as a master protocol with each candidate being evaluated within its own sub-protocol (Candidate Specific Trial (CST) protocol), randomising between candidate and SoC with 2:1 allocation in favour of the candidate (N.B the first candidate has gone through regulatory approval and is expected to open to recruitment early summer 2020). |
T9 | 1241-1317 | Sentence | denotes | Each dose will be assessed for safety sequentially in cohorts of 6 patients. |
T10 | 1318-1428 | Sentence | denotes | Once a phase II dose has been identified we will assess efficacy by seamlessly expanding into a larger cohort. |
T11 | 1429-1442 | Sentence | denotes | PARTICIPANTS: |
T12 | 1443-1661 | Sentence | denotes | Patient populations can vary between CSTs, but the main eligibility criteria include adult patients (≥18 years) who have laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). |
T13 | 1662-1736 | Sentence | denotes | We will include both severe and mild-moderate patients defined as follows: |
T14 | 1737-2242 | Sentence | denotes | Group A (severe disease) - patients with WHO Working Group on the Clinical Characteristics of COVID-19 infection 9-point ordinal scale of Grades 4 (hospitalised, oxygen by mask or nasal prongs), 5 (hospitalised, non-invasive ventilation or high flow oxygen), 6 (hospitalised, intubation and mechanical ventilation) or 7 (hospitalised, ventilation and additional organ support); Group B (mild-moderate disease) - ambulant or hospitalised patients with peripheral capillary oxygen saturation (SpO2) >94% RA. |
T15 | 2243-2395 | Sentence | denotes | If any CSTs are included in the community setting, the CST protocol will clarify whether patients with suspected SARS-CoV-2 infection are also eligible. |
T16 | 2396-2475 | Sentence | denotes | Participants will be recruited from England, North Ireland, Wales and Scotland. |
T17 | 2476-2504 | Sentence | denotes | INTERVENTION AND COMPARATOR: |
T18 | 2505-2581 | Sentence | denotes | Comparator is the current standard of care (SoC), in some CSTs plus placebo. |
T19 | 2582-2781 | Sentence | denotes | Candidates that prevent uncontrolled cytokine release, prevention of viral replication, and other anti-viral treatment strategies are at various stages of development for inclusion into AGILE-ACCORD. |
T20 | 2782-2817 | Sentence | denotes | Other CSTs will be added over time. |
T21 | 2818-2999 | Sentence | denotes | There is not a set limit on the number of CSTs we can include within the AGILE-ACCORD Master protocol and we will upload each CST into this publication as each opens to recruitment. |
T22 | 3000-3014 | Sentence | denotes | MAIN OUTCOMES: |
T23 | 3015-3023 | Sentence | denotes | Phase I: |
T24 | 3024-3129 | Sentence | denotes | Dose limiting toxicities using Common Terminology Criteria for Adverse Events v5 Grade ≥3 adverse events. |
T25 | 3130-3139 | Sentence | denotes | Phase II: |
T26 | 3140-3235 | Sentence | denotes | Agreed on a CST basis depending on mechanism of action of the candidate and patient population. |
T27 | 3236-3556 | Sentence | denotes | But may include; time to clinical improvement of at least 2 points on the WHO 9-point category ordinal scale [measured up to 29 days from randomisation], progression of disease (oxygen saturation (SaO2) <92%) or hospitalization or death, or change in time-weighted viral load [measured up to 29 days from randomisation]. |
T28 | 3557-3571 | Sentence | denotes | RANDOMISATION: |
T29 | 3572-3676 | Sentence | denotes | Varies with CST, but default is 2:1 allocation in favour of the candidate to maximise early safety data. |
T30 | 3677-3696 | Sentence | denotes | BLINDING (MASKING): |
T31 | 3697-3802 | Sentence | denotes | For the safety phase open-label although for some CSTs may include placebo or SoC for the efficacy phase. |
T32 | 3803-3842 | Sentence | denotes | NUMBERS TO BE RANDOMISED (SAMPLE SIZE): |
T33 | 3843-3863 | Sentence | denotes | Varies between CSTs. |
T34 | 3864-4228 | Sentence | denotes | However simulations have shown that around 16 participants are necessary to determine futility or promise of a candidate at a given dose (in efficacy evaluation alone) and between 32 and 40 participants are required across the dose-finding and efficacy evaluation when capping the maximum number of participants contributing to the evaluation of a treatment at 40. |
T35 | 4229-4242 | Sentence | denotes | TRIAL STATUS: |
T36 | 4243-4522 | Sentence | denotes | Master protocol version number v5 07 May 2020, trial is in setup with full regulatory approval and utilises several digital technology solutions, including Medidata's Rave EDC [electronic data capture], RTSM for randomisation and patient eConsent on iPads via Rave Patient Cloud. |
T37 | 4523-4632 | Sentence | denotes | The recruitment dates will vary between CSTs but at the time of writing no CSTs are yet open for recruitment. |
T38 | 4633-4652 | Sentence | denotes | TRIAL REGISTRATION: |
T39 | 4653-4706 | Sentence | denotes | EudraCT 2020-001860-27 14th March 2020 FULL PROTOCOL: |
T40 | 4707-4815 | Sentence | denotes | The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). |
T41 | 4816-4996 | Sentence | denotes | In the interest in 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. |
chenxin_473849_800_3
Id | Subject | Object | Predicate | Lexical cue |
---|---|---|---|---|
T1 | 888-896 | DP | denotes | COVID-19 |
T2 | 187-195 | DP | denotes | COVID-19 |
T3 | 1831-1839 | DP | denotes | COVID-19 |
T4 | 1649-1659 | DP | denotes | SARS-CoV-2 |
T5 | 2356-2366 | DP | denotes | SARS-CoV-2 |
T6 | 1600-1647 | DP | denotes | severe acute respiratory syndrome coronavirus 2 |
yangbin123xm_800_3
Id | Subject | Object | Predicate | Lexical cue |
---|---|---|---|---|
T1 | 187-195 | DP | denotes | COVID-19 |
T2 | 888-896 | DP | denotes | COVID-19 |
T3 | 1831-1839 | DP | denotes | COVID-19 |
T4 | 1649-1659 | DP | denotes | SARS-CoV-2 |
T5 | 2356-2366 | DP | denotes | SARS-CoV-2 |
T6 | 1600-1647 | DP | denotes | severe acute respiratory syndrome coronavirus 2 |