| Trial registration number
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NCT05165992 |
Full text link
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05165992
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First author
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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Abdulqadir J Nashwan
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Contact
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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ANashwan@hamad.qa
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Registration date
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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2021-12-21
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Recruitment status
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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Not recruiting
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Study design
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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unclear
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Study aim
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
age: 18 - 65 years
confirmed diagnosis (covid-19) - positive pcr
tachypnoea (respiratory rate> 30/min)
ability to provide informed consent and perform all study procedures
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Exclusion criteria
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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history of allergy or adverse reaction to fentanyl or other opioids
pregnancy
active neuromuscular or musculoskeletal disease.
active malignancy
morbid obesity (body mass index >40)
use of opioids in the previous 4 weeks.
inability to provide informed consent and perform all study procedures.
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Number of arms
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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Hamad Medical Corporation
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Inclusion age min
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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65
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Countries
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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None
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Type of patients
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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Severe disease at enrollment
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Severity scale
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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6: Severe disease at enrollment
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Total sample size
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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200
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primary outcome
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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Breathlessness;Cough;Throat Pain
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Notes
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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Phase 3
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Arms
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "nebulized", "treatment_id": 508, "treatment_name": "Fentanyl", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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