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. |