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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04360980
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
nooshin dalili, Shahid Beheshti University of Medical Sciences

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 .

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Colchicine Tablets Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Standard Protocol Therapy With or Without Colchicine in Covid-19 Infection: A Randomized Double Blind Clinical Trial
Actual Study Start Date : March 20, 2020
Estimated Primary Completion Date : May 20, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
Active Comparator: Intervention
40 RT-PCR positive COVID-19 patients without hypoxemia administered Colchicine plus standard treatment
Drug: Colchicine Tablets
1.5 mg loading then 0.5 mg BID P.O
Other Name: Colchicine

No Intervention: 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



Primary Outcome Measures :
  1. CRPxN/R ratio change [ Time Frame: 2 weeks ]
    increasing inflammatory status

  2. Clinical deterioration by the WHO definition [ Time Frame: 2 weeks ]
    including change in fever or O2 Saturation

  3. PCR Viral Load [ Time Frame: 2 weeks ]
    change in RT-PCR

  4. CT severity involvement index [ Time Frame: 2weeks ]
    change in CT involvement


Secondary Outcome Measures :
  1. LDH change [ Time Frame: 2 weeks ]
    change in LDH



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360980


Contacts
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Contact: CKDRC,SBMU, MD 00989122404331 nooshindalili4@gmail.com

Locations
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Iran, Islamic Republic of
SBMU Recruiting
Tehran, Iran, Islamic Republic of, 1666664321
Contact: Nooshin Dalili, MD    00989122404331    nooshindalili4@gmail.com   
Contact       nooshindalili4@gmail.com   
Nooshin Dalili Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nooshin Dalili, Dr    00989122404331    nooshindalili4@gmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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Principal Investigator: SBMU CKDRC,SBMU
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Responsible Party: nooshin dalili, Principal Investigator, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04360980    
Other Study ID Numbers: SBMU.IR.REC.165423
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents