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Completed

NCT Number: NCT04360980

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

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 .

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nooshin Dalili, Tehran, Iran

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine Tablets

Drug

1.5 mg loading then 0.5 mg BID P.O

Other names: Colchicine

Primary outcomes

  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 outcomes

  1. LDH change

    Time frame: 2 weeks

    change in LDH

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

Effects of Standard Protocol Therapy With or Without Colchicine in Covid-19 Infection: A Randomized Double Blind Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2020
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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