LitCovid-sentences  

PubMed:32522282 JSONTXT 16 Projects

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Id Subject Object Predicate Lexical cue
T1 0-117 Sentence denotes Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID):
T2 118-193 Sentence denotes A structured summary of a study protocol for a randomised controlled trial.
T3 194-205 Sentence denotes OBJECTIVES:
T4 206-686 Sentence denotes The aim of this randomised GCP-controlled trial is to clarify whether combination therapy with the antibiotic azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy and pre-emptive treatment of supra-infections can shorten hospitalisation duration for patients with COVID-19 (measured as "days alive and out of hospital" as the primary outcome), reduce the risk of non- invasive ventilation, treatment in the intensive care unit and death.
T5 687-700 Sentence denotes TRIAL DESIGN:
T6 701-808 Sentence denotes This is a multi-centre, randomised, Placebo-controlled, 2-arm ratio 1:1, parallel group double-blind study.
T7 809-822 Sentence denotes PARTICIPANTS:
T8 823-927 Sentence denotes 226 participants are recruited at the trial sites/hospitals, where the study will take place in Denmark:
T9 928-1017 Sentence denotes Aalborg, Bispebjerg, Gentofte, Herlev, Hillerød, Hvidovre, Odense and Slagelse hospitals.
T10 1018-1301 Sentence denotes INCLUSION CRITERIA: • Patient admitted to Danish emergency departments, respiratory medicine departments or internal medicine departments • Age≥ 18 years • Hospitalized ≤48 hours • Positive COVID-19 test / diagnosis during the hospitalization (confirmed). • Men or non-fertile women.
T11 1302-2613 Sentence denotes Fertile women* must not be pregnant, i.e. negative pregnancy test must be available at inclusion • Informed consent signed by the patient *Defined as after menarche and until postmenopausal (no menstruation for 12 months) Exclusion criteria: • At the time of recruitment, the patient uses >5 LO2/min (equivalent to 40% FiO2 if measured) • Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinoline derivatives • Neurogenic hearing loss • Psoriasis • Retinopathy • Maculopathy • Visual field changes • Breastfeeding • Severe liver diseases other than amoebiasis (INR> 1.5 spontaneously) • Severe gastrointestinal, neurological and hematological disorders (investigator-assessed) • eGFR <45 ml/min/1.73 m2 • Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) of> 480/470 ms). • Myasthenia gravis • Treatment with digoxin* • Glucose-6-phosphate dehydrogenase deficiency • Porphyria • Hypoglycaemia (Blood glucose at any time since hospitalization of <3.0 mmol/L) • Severe mental illness which significantly impedes cooperation • Severe linguistic problems that significantly hinder cooperation • Treatment with ergot alkaloids *The patient must not be treated with digoxin for the duration of the intervention.
T12 2614-2717 Sentence denotes For atrial fibrillation/flutter, select according to the Cardiovascular National Treatment Guide (NBV):
T13 2718-2797 Sentence denotes Calcium antagonist, Beta blocker, direct current (DC) conversion or amiodarone.
T14 2798-2967 Sentence denotes In case of urgent need for digoxin treatment (contraindication for the aforementioned equal alternatives), the test drug should be paused, and ECG should be taken daily.
T15 2968-2996 Sentence denotes INTERVENTION AND COMPARATOR:
T16 2997-3011 Sentence denotes Control group:
T17 3012-3131 Sentence denotes The control group will receive the standard treatment + placebo for both types of intervention medication at all times.
T18 3132-3282 Sentence denotes If part or all the intervention therapy being investigated becomes standard treatment during the study, this may also be offered to the control group.
T19 3283-3302 Sentence denotes Intervention group:
T20 3303-3374 Sentence denotes The patients in the intervention group will also receive standard care.
T21 3375-3472 Sentence denotes Immediately after randomisation to the intervention group, the patient will begin treatment with:
T22 3473-3486 Sentence denotes Azithromycin:
T23 3487-3495 Sentence denotes Day 1-3:
T24 3496-3516 Sentence denotes 500 mg x 1 Day 4-15:
T25 3517-3872 Sentence denotes 250 mg x 1 If the patient is unable to take the medication orally by themselves, the medication will, if possible, be administered by either stomach-feeding tube, or alternatively, temporary be changed to clarithromycin 500 mg x 2 (this only in agreement with either study coordinator Pradeesh Sivapalan or principal investigator Jens-Ulrik Stæhr Jensen).
T26 3873-3930 Sentence denotes This will also be done in the control group if necessary.
T27 3931-3990 Sentence denotes The patient will switch back to azithromycin when possible.
T28 3991-4010 Sentence denotes Hydroxychloroquine:
T29 4011-4087 Sentence denotes Furthermore, the patient will be treated with hydroxychloroquine as follows:
T30 4088-4097 Sentence denotes Day 1-15:
T31 4098-4316 Sentence denotes 200 mg x 2 MAIN OUTCOMES: • Number of days alive and discharged from hospital within 14 days (summarises both whether the patient is alive and discharged from hospital) ("Days alive and out of hospital") RANDOMISATION:
T32 4317-4428 Sentence denotes The sponsor (Chronic Obstructive Pulmonary Disease Trial Network, COP:TRIN) generates a randomisation sequence.
T33 4429-4544 Sentence denotes Randomisation will be in blocks of unknown size and the final allocation will be via an encrypted website (REDCap).
T34 4545-4771 Sentence denotes There will be stratification for age (>70 years vs. <=70 years), site of recruitment and whether the patient has any of the following chronic lung diseases: COPD, asthma, bronchiectasis, interstitial lung disease (Yes vs. No).
T35 4772-4791 Sentence denotes BLINDING (MASKING):
T36 4792-4914 Sentence denotes Participants and study personnel will both be blinded, i.e. neither will know which group the participant is allocated to.
T37 4915-4954 Sentence denotes NUMBERS TO BE RANDOMISED (SAMPLE SIZE):
T38 4955-5026 Sentence denotes This study requires 226 patients randomised 1:1 with 113 in each group.
T39 5027-5040 Sentence denotes TRIAL STATUS:
T40 5041-5083 Sentence denotes Protocol version 1.8, from April 16, 2020.
T41 5084-5204 Sentence denotes Recruitment is ongoing (first patient recruited April 6, 2020; final patient expected to be recruited October 31, 2020).
T42 5205-5224 Sentence denotes TRIAL REGISTRATION:
T43 5225-5310 Sentence denotes ClinicalTrials.gov Identifier: NCT04322396 (registered March 26, 2020) FULL PROTOCOL:
T44 5311-5419 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T45 5420-5600 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.
T46 5601-5685 Sentence denotes The study protocol has been reported in accordance with the Standard Protocol Items:
T47 5686-5777 Sentence denotes Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).