LitCovid-sentences  

PubMed:33407777 JSONTXT 11 Projects

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Id Subject Object Predicate Lexical cue
T1 0-186 Sentence denotes Double-blind, randomized, controlled, trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19 (COVID-AT):
T2 187-262 Sentence denotes A structured summary of a study protocol for a randomised controlled trial.
T3 263-274 Sentence denotes OBJECTIVES:
T4 275-277 Sentence denotes 1.
T5 278-394 Sentence denotes To assess the efficacy of Mesenchymal Stromal Cells (MSC) versus a control arm as described in the primary endpoint.
T6 395-397 Sentence denotes 2.
T7 398-465 Sentence denotes To evaluate the effects of MSC on the secondary efficacy endpoints.
T8 466-468 Sentence denotes 3.
T9 469-525 Sentence denotes To evaluate the safety and tolerability profiles of MSC.
T10 526-528 Sentence denotes 4.
T11 529-670 Sentence denotes To study soluble and cellular biomarkers that might be involved in the course of the disease and the response to the investigational product.
T12 671-684 Sentence denotes TRIAL DESIGN:
T13 685-901 Sentence denotes A double-blind, randomized, controlled, trial to evaluate the efficacy and safety of MSC intravenous administration in patients with COVID-induced Acute Respiratory Distress Syndrome (ARDS) compared to a control arm.
T14 902-915 Sentence denotes PARTICIPANTS:
T15 916-1044 Sentence denotes The trial is being conducted at a third level hospital, Hospital Universitario Puerta de Hierro, in Majadahonda, Madrid (Spain).
T16 1045-1066 Sentence denotes Inclusion criteria 1.
T17 1067-1227 Sentence denotes Informed consent prior to performing study procedures (witnessed oral consent with written consent by representatives will be accepted to avoid paper handling).
T18 1228-1309 Sentence denotes Written consent by patient or representatives will be obtained whenever possible.
T19 1310-1312 Sentence denotes 2.
T20 1313-1370 Sentence denotes Adult patients ≥18 years of age at the time of enrolment.
T21 1371-1373 Sentence denotes 3.
T22 1374-1562 Sentence denotes Laboratory-confirmed SARS-CoV-2 infection as determined by Polymerase Chain Reaction (PCR), in oropharyngeal swabs or any other relevant specimen obtained during the course of the disease.
T23 1563-1710 Sentence denotes Alternative tests (e.g., rapid antigen tests) are also acceptable as laboratory confirmation if their specificity has been accepted by the Sponsor.
T24 1711-1713 Sentence denotes 4.
T25 1714-1836 Sentence denotes Moderate to severe ARDS (PaO2/FiO2 ratio equal or less than 200 mmHg) for less than 96 hours at the time of randomization.
T26 1837-1839 Sentence denotes 5.
T27 1840-1925 Sentence denotes Patients requiring invasive ventilation are eligible within 72 hours from intubation.
T28 1926-1928 Sentence denotes 6.
T29 1929-1988 Sentence denotes Eligible for ICU admission, according to the clinical team.
T30 1989-2010 Sentence denotes Exclusion criteria 1.
T31 2011-2156 Sentence denotes Imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments (in the opinion of the clinical team).
T32 2157-2206 Sentence denotes 2. "Do Not Attempt Resuscitation" order in place.
T33 2207-2209 Sentence denotes 3.
T34 2210-2345 Sentence denotes Any end-stage organ disease or condition, which in the investigator's opinion, makes the patient an unsuitable candidate for treatment.
T35 2346-2348 Sentence denotes 4.
T36 2349-2428 Sentence denotes History of a moderate/severe lung disorder requiring home-based oxygen therapy.
T37 2429-2431 Sentence denotes 5.
T38 2432-2566 Sentence denotes Patient requiring Extracorporeal Membrane Oxygenation (ECMO), haemodialysis or hemofiltration at the time of treatment administration.
T39 2567-2569 Sentence denotes 6.
T40 2570-2610 Sentence denotes Current diagnosis of pulmonary embolism.
T41 2611-2613 Sentence denotes 7.
T42 2614-2669 Sentence denotes Active neoplasm, except carcinoma in situ or basalioma.
T43 2670-2672 Sentence denotes 8.
T44 2673-2753 Sentence denotes Known allergy to the products involved in the allogeneic MSC production process.
T45 2754-2756 Sentence denotes 9.
T46 2757-2900 Sentence denotes Current pregnancy or lactation (women with childbearing potential should have a negative pregnancy test result at the time of study enrolment).
T47 2901-2904 Sentence denotes 10.
T48 2905-3095 Sentence denotes Current participation in a clinical trial with an experimental treatment for COVID-19 (the use of any off-label medicine according to local treatment protocols is not an exclusion criteria).
T49 3096-3099 Sentence denotes 11.
T50 3100-3224 Sentence denotes Any circumstances that in the investigator's opinion compromises the patient's ability to participate in the clinical trial.
T51 3225-3283 Sentence denotes INTERVENTION AND COMPARATOR: - Experimental treatment arm:
T52 3284-3431 Sentence denotes Allogeneic MSC (approximately 1 x 106 cells/kg). - Control arm: placebo solution (same composition as the experimental treatment, without the MSC).
T53 3432-3529 Sentence denotes One single intravenous dose of the assigned treatment will be administered on Day 0 of the study.
T54 3530-3589 Sentence denotes All trial participants will receive standard of care (SOC).
T55 3590-3832 Sentence denotes In the context of the current worldwide pandemic, SOC can include medicines that are being used in clinical practice (e.g. lopinavir/ritonavir; hydroxy/chloroquine, tocilizumab, etc.), as well as those authorised for COVID (e.g., remdesivir).
T56 3833-3847 Sentence denotes MAIN OUTCOMES:
T57 3848-3865 Sentence denotes Primary endpoint:
T58 3866-4018 Sentence denotes Change in the PaO2/FiO2 ratio from baseline to day 7 of treatment administration, or to the last available PaO2/FiO2 ratio if death occurs before day 7.
T59 4019-5993 Sentence denotes Secondary endpoints: - All-cause mortality on days 7, 14, and 28 after treatment. - PaO2/FiO2 ratio at baseline and days 2, 4, 7, 14 and 28 after treatment. - Oxygen saturation (by standardized measurement) at baseline, daily until day 14, and on day 28 after treatment. - Time to PaO2/FiO2 ratio greater than 200 mmHg. - Subjects' clinical status on the WHO 7-point ordinal scale at baseline, daily until day 14, and on day 28 after treatment. - Time to an improvement of one category from admission on the WHO 7-point ordinal scale. - Percentage of patients that worsen at least one category on the WHO 7-point ordinal scale. - Percentage of patients that improve at least one category (maintained 48h) on the WHO 7-point ordinal scale. - Sequential Organ Failure Assessment (SOFA) scale at baseline and days 2, 4, 7, 14 and 28 after treatment. - Duration of hospitalization (days). - Duration of ICU stay (days). - Oxygen therapy-free days in the first 28 days after treatment. - Duration of supplemental oxygen. - Incidence of and duration of non-invasive and invasive mechanical ventilation in the first 28 days after treatment. - Mechanical ventilation-free days in the first 28 days after treatment. - Ventilation parameters. - Incidence of new onset pulmonary fibrosis at 3 and 12 months after treatment, based on CT scan and pulmonary function tests. - Survival at 3 and 12 months. - Cumulative incidence of Serious Adverse events (SAEs) and Grade 3 and 4 Adverse Events (AEs). - Cumulative incidence of Adverse Drug Reactions (ADR) in the experimental treatment arm. - Cumulative incidence of AEs of special interest. - Levels of analytical markers (C-Reactive Protein, lymphocyte and neutrophil counts, lymphocyte subpopulations, LDH, ferritin, D-dimer, coagulation tests and cytokines...) at baseline and days 2, 4, 7, 14 and 28 after treatment. - Other soluble and cellular biomarkers that might be involved in the course of the disease and the response to MSC.
T60 5994-6008 Sentence denotes RANDOMISATION:
T61 6009-6101 Sentence denotes The assignment to treatment will be carried out randomly and blinded, with a 1:1 allocation.
T62 6102-6208 Sentence denotes Randomization will be done through a centralized system embedded in the electronic Case Report Form (CRF).
T63 6209-6228 Sentence denotes BLINDING (MASKING):
T64 6229-6459 Sentence denotes To ensure blinding, treatments will be prepared for administration at the Cell Production Unit and the administration of the treatment will be masked, not allowing the identification of the Investigational Medicinal Product (IMP).
T65 6460-6499 Sentence denotes NUMBERS TO BE RANDOMISED (SAMPLE SIZE):
T66 6500-6584 Sentence denotes A total of 20 participants are planned to be randomized, 10 to each treatment group.
T67 6585-6598 Sentence denotes TRIAL STATUS:
T68 6599-6616 Sentence denotes Protocol version:
T69 6617-6668 Sentence denotes 1.2, dated October 14th, 2020 Start of recruitment:
T70 6669-6711 Sentence denotes 01/10/2020 End of recruitment (estimated):
T71 6712-6726 Sentence denotes December 2020.
T72 6727-6746 Sentence denotes TRIAL REGISTRATION:
T73 6747-6762 Sentence denotes EudraCT Number:
T74 6763-6810 Sentence denotes 2020-002193-27 , registered on July 14th, 2020.
T75 6811-6870 Sentence denotes NCT number: NCT04615429 , registered on November 4th, 2020.
T76 6871-6885 Sentence denotes FULL PROTOCOL:
T77 6886-6994 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T78 6995-7175 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.