The Effects of Standard Protocol With or Without Colchicine in Covid-19 Infection
Effects of Standard Protocol Therapy With or Without Colchicine in Covid-19 Infection: A Randomized Double Blind Clinical Trial
1 other identifier
interventional
80
1 country
2
Brief Summary
Based on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on COVID-19 Polymerase chain reaction(PCR) positive patients .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 covid19
Started Mar 2020
Typical duration for phase_2 covid19
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2020
CompletedFirst Submitted
Initial submission to the registry
April 22, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2021
CompletedJanuary 28, 2022
January 1, 2022
10 months
April 22, 2020
January 27, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
CRPxN/R ratio change
increasing inflammatory status
2 weeks
Clinical deterioration by the WHO definition
including change in fever or O2 Saturation
2 weeks
PCR Viral Load
change in RT-PCR
2 weeks
CT severity involvement index
change in CT involvement
2weeks
Secondary Outcomes (1)
LDH change
2 weeks
Study Arms (2)
Intervention
ACTIVE COMPARATOR40 RT-PCR positive COVID-19 patients without hypoxemia administered Colchicine plus standard treatment
Standard treatment
NO INTERVENTION40 RT-PCR positive COVID-19 patients without hypoxemia receiving vitamin C 3grams daily , 400 mg Tiamine, Selenium , Omega-3 500 mg daily, Vit A , Vit D, Azithromycine, Ceftriaxone, Kaletra 400 BID 10 days
Interventions
Eligibility Criteria
You may qualify if:
- Patients \>18 years old with nasopharyngeal swab confirmed COVID-19 PCR, CT involvement compatible with COVID, Fever and Dyspnea without hypoxemia.
You may not qualify if:
- Patient who is not willing to enter in study
- Known hypersensitivity to colchicine
- Hepatic failure
- Renal failure with eGFR\<20 ml/min
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
SBMU
Tehran, 1666664321, Iran
Nooshin Dalili
Tehran, Iran
Related Publications (1)
Dalili N, Kashefizadeh A, Nafar M, Poorrezagholi F, Firouzan A, Samadian F, Samavat S, Ziaie S, Fatemizadeh S. Adding Colchicine to the Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra) in Hospitalized Patients with Non-Severe Covid-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomized Controlled Trial. Trials. 2020 Jun 5;21(1):489. doi: 10.1186/s13063-020-04455-3.
PMID: 32503620DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
SBMU
CKDRC,SBMU
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 22, 2020
First Posted
April 24, 2020
Study Start
March 20, 2020
Primary Completion
January 1, 2021
Study Completion
January 30, 2021
Last Updated
January 28, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share