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The Effects of Standard Protocol With or Without Colchicine in Covid-19 Infection

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Colchicine Tablets
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients >18 years old with nasopharyngeal swab confirmed COVID-19 PCR, CT involvement compatible with COVID, Fever and Dyspnea without hypoxemia.

Exclusion Criteria:

  • Patient who is not willing to enter in study
  • Known hypersensitivity to colchicine
  • Hepatic failure
  • Renal failure with eGFR<20 ml/min

Sites / Locations

  • SBMU
  • Nooshin Dalili

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Standard treatment

Arm Description

40 RT-PCR positive COVID-19 patients without hypoxemia administered Colchicine plus standard treatment

40 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

Outcomes

Primary Outcome Measures

CRPxN/R ratio change
increasing inflammatory status
Clinical deterioration by the WHO definition
including change in fever or O2 Saturation
PCR Viral Load
change in RT-PCR
CT severity involvement index
change in CT involvement

Secondary Outcome Measures

LDH change
change in LDH

Full Information

First Posted
April 22, 2020
Last Updated
January 27, 2022
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04360980
Brief Title
The Effects of Standard Protocol With or Without Colchicine in Covid-19 Infection
Official Title
Effects of Standard Protocol Therapy With or Without Colchicine in Covid-19 Infection: A Randomized Double Blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 .
Detailed Description
80 Patients with positive nasopharyngeal swab PCR for COVID-19 which were not hypoxic but showed computed tomography involvement compatible with COVID-19 admitted in ward (not in Intensive care unit) included and randomized in to two groups. All patients received standard treatment protocol including essential minerals, vitamins as antioxidants, antibiotics and Kaletra while in one randomly assigned group colchicine would be added.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
40 RT-PCR positive COVID-19 patients without hypoxemia administered Colchicine plus standard treatment
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
40 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
Intervention Type
Drug
Intervention Name(s)
Colchicine Tablets
Other Intervention Name(s)
Colchicine
Intervention Description
1.5 mg loading then 0.5 mg BID P.O
Primary Outcome Measure Information:
Title
CRPxN/R ratio change
Description
increasing inflammatory status
Time Frame
2 weeks
Title
Clinical deterioration by the WHO definition
Description
including change in fever or O2 Saturation
Time Frame
2 weeks
Title
PCR Viral Load
Description
change in RT-PCR
Time Frame
2 weeks
Title
CT severity involvement index
Description
change in CT involvement
Time Frame
2weeks
Secondary Outcome Measure Information:
Title
LDH change
Description
change in LDH
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients >18 years old with nasopharyngeal swab confirmed COVID-19 PCR, CT involvement compatible with COVID, Fever and Dyspnea without hypoxemia. Exclusion Criteria: Patient who is not willing to enter in study Known hypersensitivity to colchicine Hepatic failure Renal failure with eGFR<20 ml/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SBMU
Organizational Affiliation
CKDRC,SBMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
SBMU
City
Tehran
ZIP/Postal Code
1666664321
Country
Iran, Islamic Republic of
Facility Name
Nooshin Dalili
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32503620
Citation
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.
Results Reference
derived

Learn more about this trial

The Effects of Standard Protocol With or Without Colchicine in Covid-19 Infection

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