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| Column | Value |
|---|---|
| Trial registration number | NCT05151614 |
|
Full text link
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
2021-12-09 |
|
Recruitment status
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
inclusion criteria: 1. patients with age above 18 years and of any gender 2. definite diagnosis of covid-19 according to the who classification criteria 3. patients symptomatic for no more than three days for mild-moderate cases, no more than two days after being severe cases 4. understands and agrees to comply with planned study procedures. |
|
Exclusion criteria
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
patients refuse to enrol in the study patients with hypersensitivity to colchicine patients with chronic diseases: renal failure with egfr<30 ml/min; chronic liver disease with hepatic failure (ast/alt > 3x normal).; decompensated heart failure, long qt syndrome (qtc >450 msec.), and uncontrolled arrhythmia; inflammatory bowel disease, chronic diarrhea or malabsorption; pre-existent progressive neuromuscular disease, and metastatic cancer pregnancy and breast feeding medications: immunosuppressive chemotherapy; regular use of digoxin, amiodarone, verapamil or protease inhibitors. |
|
Number of arms
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
University of Baghdad |
|
Inclusion age min
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
Iraq |
|
Type of patients
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
|
Severity scale
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
|
Total sample size
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
160 |
|
primary outcome
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
- Study the time to recovery;- To assess the percentage of cure of the patients |
|
Notes
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
Phase 1 |
|
Arms
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |