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Trial - NCT04527562


Column Value
Trial registration number NCT04527562
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04527562

First author
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Motlabur Rahman, MBBS, FCPS,FACP

Contact
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

rahmanmotlabur@gmail.com

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-08-26

Recruitment status
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: males and females of least 18 years of age and can swallow tablets competent and willing to provide informed consent patient must have received a diagnosis of covid-19 infection with positive rt-pcr for sars cov-2 within the last 3 days patients with moderate symptoms (according to national guidelines on clinical management of coronavirus disease 2019 (covid- 19).version 7.0 .2020, dghs, mohfw, government of the people's republic of bangladesh). following features of moderate covid-19 must be present- fever or history of fever cough and /or shortness of breath oxygen saturation 94% or more pneumonia -pulmonary consolidations on chest imaging (chest x ray or ct scan of chest) involving less than 50%of lungs crb 65 score 0

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- pregnancy and breast-feeding - known hypersensitivity to colchicine - known chronic illness e.g hepatic failure, chronic kidney disease (egfr<30ml/min), decompensated heart failure, long qt syndrome (qtc >450 msec.) - patient with inflammatory bowel disease (crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption - patient currently taking colchicine for other indications (mainly chronic indications represented by familial mediterranean fever or gout) - patient undergoing chemotherapy for cancer - patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Dhaka Medical College

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Bangladesh

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

3: Moderate disease at enrollment

Total sample size
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

299

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Time to develop clinical deterioration, defined as the time from randomization to a deterioration of two points (from the status at randomization) on a Seven-category ordinal scale.

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]