Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04667780
Status:
COMPLETED
Last Update Posted:
2023-01-05
First Post:
2020-12-11
Brief Title:
Study to Investigate the Treatment Effect of Colchicine in Patients With COVID-19
Sponsor:
Ayub Teaching Hospital
Organization:
Ayub Teaching Hospital
Study Overview
Official Title:
Study to Investigate the Treatment Effect of Colchicine in Patients With COVID-19
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
COVID-19 is associated with a cytokine storm that leads to respiratory distress multiorgan failure and elevated mortality Oral Colchicine exhibits high anti-inflammatory capacity attributed to the inhibition of microtubules polymerization inflammasome and production of IL-1β and IL-6 which could prevent the inflammatory storm in COVID-19 patients at risk The investigators present a randomized controlled open-labeled and pragmatic clinical trial to study the treatment effect of Colchicine in COVID-19 patients requiring hospitalization but no intensive care yet Colchicine will be started within the first 48 hours and continue for 14 days using a descending dose The benefits will be studied in terms of clinical evolution WHO 7-point scale and IL-6 levels as well as other clinical and biochemical secondary end-points In the case of positive results the clinical impact would be relevant given that this oral medication is affordable and widely accessible which would help to prevent the inflammatory complications associated with COVID-19
Detailed Description:
This is a Phase III prospective pragmatic randomized controlled and open-label trial comparing standard of care vs standard of care plus COLCHICINE for 14 days in patients hospitalized due to COVID-19 and confirmed infection by SARS-CoV-2 within the first 48 hours after the hospital admission Patients meeting severity criteria will be excluded defined as established limitation of therapeutic effort or need for invasive mechanical ventilation at the time of inclusion The Colchicine treatment includes an initial dose of 15 mg 1 mg and 05 mg two hours after followed by 05 mg every 12 hours during the next 7 days and 05 mg every 24 hours until the completion of 14 days of total treatment In patients receiving ritonavir or lopinavir or with reduced renal clearance 50 mlmin137m2 weight 70 kg or age 75 years old the dose will be adjusted to the half
Patients meeting all the inclusion criteria and none of the exclusion ones see below after signing the informed consent will be centrally randomized to Colchicine or Control group Patients in both groups will receive the standard therapy for COVID-19 as per the hospital protocols Randomization will be controlled by age sex time from initiation of symptoms cardiovascular disease the 7 point WHO and levels of C-reactive protein ferritin D-dimer IL-6 and lymphocyte levels
Patients meeting all the inclusion criteria and none of the exclusion ones see below after signing the informed consent will be centrally randomized to Colchicine or Control group Patients in both groups will receive the standard therapy for COVID-19 as per the hospital protocols Randomization will be controlled by age sex time from initiation of symptoms cardiovascular disease the 7 point WHO and levels of C-reactive protein ferritin D-dimer IL-6 and lymphocyte levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None