PubMed:32586363 JSONTXT 14 Projects

Annnotations TAB TSV DIC JSON TextAE Lectin_function

Id Subject Object Predicate Lexical cue
T1 0-168 Sentence denotes Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: a structured summary of a study protocol for a randomised controlled trial.
T2 169-180 Sentence denotes OBJECTIVES:
T3 181-335 Sentence denotes In this study, we investigate the effect of hydroxychloroquine on the prevention of Novel Coronavirus Disease (COVID-19) in cancer patients being treated.
T4 336-349 Sentence denotes TRIAL DESIGN:
T5 350-451 Sentence denotes This is a multi-centre, two-arm, parallel-group, triple-blind, phase 2-3 randomised controlled trial.
T6 452-465 Sentence denotes PARTICIPANTS:
T7 466-547 Sentence denotes All patients over the age of 15 from 5 types of cancer are included in the study.
T8 548-836 Sentence denotes Patients with acute lymphoid and myeloid leukemias in the first line treated with curative intent, patients with high-grade non-Hodgkin's lymphoma treated with leukemia protocols and patients with non-metastatic breast and colon cancer in the first line of treatment will enter the study.
T9 837-1319 Sentence denotes The exclusion criteria will include known sensitivity to Hydroxychloroquine, weight below 35 kilograms, history of retinopathy, history of any cardiac disease, acute respiratory tract infection in the last 2 months, having COVID-19 in the first two weeks of entering the trial, having Diabetes Mellitus, having an immuno-suppressive disease other than cancer, having chronic pulmonary disease and taking immuno-suppressant drug other than chemotherapeutic agents for current cancer.
T10 1320-1437 Sentence denotes This study is performed in five academic centres affiliated to Mashhad University of Medical Sciences, Mashhad, Iran.
T11 1438-1466 Sentence denotes INTERVENTION AND COMPARATOR:
T12 1467-1579 Sentence denotes Patients are randomly assigned to two groups; one being given hydroxychloroquine and the other is given placebo.
T13 1580-1814 Sentence denotes During two months of treatment, the two groups are treated with either hydroxychloroquine (Amin® Pharmaceutical Company, Isfahan, Iran) or placebo (identical in terms of shape, colour, smell) as a single 200 mg tablet every other day.
T14 1815-1892 Sentence denotes Patients will be monitored for COVID-19 symptoms during the follow-up period.
T15 1893-2174 Sentence denotes If signs or symptoms occur (fever, cough, shortness of breath), they will be examined and investigated with a high-resolution computed tomography (CT) scan of the lungs, COVID-19 specific IgM, IgG antibody assay and a nucleic acid amplification test (NAT) for the SARS-CoV-2 virus.
T16 2175-2189 Sentence denotes MAIN OUTCOMES:
T17 2190-2335 Sentence denotes The primary end point of this study is to investigate the incidence of COVID-19 in patients being treated for their cancer over a 2-month period.
T18 2336-2350 Sentence denotes RANDOMISATION:
T19 2351-2414 Sentence denotes Randomisation will be performed using randomly permuted blocks.
T20 2415-2530 Sentence denotes By using an online website (www.randomization.com) the randomization sequence will be produced by quadruple blocks.
T21 2531-2594 Sentence denotes The allocation ratio in intervention and control groups is 1:1.
T22 2595-2614 Sentence denotes BLINDING (MASKING):
T23 2615-2719 Sentence denotes Participants and caregivers do not know whether the patient is in the intervention or the control group.
T24 2720-2799 Sentence denotes The outcome assessor and the data analyst are also blinded to group assignment.
T25 2800-2839 Sentence denotes NUMBERS TO BE RANDOMISED (SAMPLE SIZE):
T26 2840-2920 Sentence denotes The calculated total sample size is 60 patients, with 30 patients in each group.
T27 2921-2934 Sentence denotes TRIAL STATUS:
T28 2935-2996 Sentence denotes The trial began on April 14, 2020 and recruitment is ongoing.
T29 2997-3163 Sentence denotes Recruitment is anticipated to be completed by June 14, 2020 There has been no change in study protocol since approval, protocol version 1 was approved April 12, 2020.
T30 3164-3183 Sentence denotes TRIAL REGISTRATION:
T31 3184-3460 Sentence denotes This trial has been registered by the title of "Effect of Hydroxychloroquine on Novel Coronavirus Disease (COVID-19) prevention in cancer patients under treatment" in Iranian Registry of Clinical Trials (IRCT) with code "IRCT20200405046958N1", https://www.irct.ir/trial/46946.
T32 3461-3497 Sentence denotes Registration date is April 14, 2020.
T33 3498-3512 Sentence denotes FULL PROTOCOL:
T34 3513-3621 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T35 3622-3802 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.