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Colchicine TabletsWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (5)


Name (Synonyms) Correlation
drug1754 Pacing + mindfulness Wiki 0.58
drug690 Current care per UCLA treating physicians Wiki 0.58
drug2341 Standard therapy for COVID-19 according to the stablished hospital protocols. Wiki 0.58
drug1006 Graded exposure therapy Wiki 0.58
drug960 Follow up Wiki 0.41

Correlated MeSH Terms (6)


Name (Synonyms) Correlation
D001924 Brain Concussion NIH 0.58
D001927 Brain Diseases NIH 0.33
D000070642 Brain Injuries, Traumatic NIH 0.26
D001930 Brain Injuries, NIH 0.22
D016638 Critical Illness NIH 0.08
D007239 Infection NIH 0.03

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0001298 Encephalopathy HPO 0.33

There are 3 clinical trials

Clinical Trials


1 Administration of Colchicine Plus Standard Treatment vs. Standard Therapy, in Hospitalized Patients With COVID-19, Within the First 48 Hours, and no Severity Criteria.

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. We present a randomized clinical trial, controlled, open-label and pragmatic, including COVID-19 patients requiring hospitalization but no intensive care yet. Colchicine will be started within the first 48 hours and then administered for four weeks using a descending dose. The benefit will be study 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 widely accessible which would help to prevent the inflammatory complications associated with COVID-19.

NCT04350320 COVID19 Drug: Colchicine Tablets Drug: Standard therapy for COVID-19 according to the stablished hospital protocols.

Primary Outcomes

Description: improve in the clinical evolution of patients hospitalized

Measure: Changes in the patients' clinical status through the 7 points ordinal scale WHO R&D Blueprint expert group

Time: 7,14,28 Days

Description: improve in the clinical evolution of patients hospitalized

Measure: Changes in IL-6 concentrations

Time: up to day 28.

Secondary Outcomes

Description: time needed to reduce at least 2 points in the 7-point Ordinal Scale for Clinical Improvement by WHO R&D Blueprint expert group (0-7)

Measure: Improvement in the clinical status

Time: up to day 28.

Description: Sequential Organ Failure Assessment (SOFA score) (0-14)

Measure: Changes in the score for the Sequential Organ Failure Assessment (SOFA score)

Time: up to day 28.

Description: National Early Warning Score (NEWS scale

Measure: Changes in the punctuation in the National Early Warning Score

Time: up to day 28.

Measure: Number of days with invasive mechanical ventilation

Time: up to day 28.

Measure: Number of days with high flow oxygen therapy

Time: up to day 28.

Description: C-reactive protein,

Measure: Changes in other inflammatory markers

Time: up to day 28

Description: TNF-alfa,

Measure: Changes in other inflammatory markers

Time: up to day 28

Description: GDF-15,

Measure: Changes in other inflammatory markers

Time: up to day 28

Description: IL-1β

Measure: Changes in other inflammatory markers

Time: up to day 28

Description: D-dimer

Measure: Changes in severity markers

Time: up to day 28

Description: leucocytes

Measure: Changes in severity markers

Time: up to day 28

Description: lymphocytes

Measure: Changes in severity markers

Time: up to day 28

Description: platelets

Measure: Changes in severity markers

Time: up to day 28

Description: LDH

Measure: Changes in severity markers

Time: up to day 28

Description: ferritin

Measure: Changes in severity markers

Time: up to day 28

Description: myocardial stress markers hsTnT

Measure: Changes in myocardial damage

Time: up to day 28

Description: myocardial stress markers NT-proBNP

Measure: Changes in myocardial damage

Time: up to day 28

Description: RT-PCR assay

Measure: Time until reaching a virus negative status

Time: up to day 28

Description: Length of hospital stay

Measure: Length of hospital stay

Time: up to day 28

Description: Number of days in the intensive care unit.

Measure: Number of days in the intensive care unit.

Time: up to day 28

Description: Mortality

Measure: Mortality

Time: up to day 28

2 Randomized, Open-Label, Controlled Trial of Colchicine to Reduce Cardiac Injury in Hospitalized COVID-19 Patients (COLHEART-19)

Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per UCLA treating physicians versus current care per UCLA treating physicians alone (control arm). Importantly, this adaptive trial design allows for patients in either study arm to receive other investigational drugs for COVID-19 as new science emerges.

NCT04355143 COVID-19 Drug: Colchicine Tablets Other: Current care per UCLA treating physicians

Primary Outcomes

Description: Number of participants experiencing any of the following: All-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS)

Measure: Composite of all-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS)

Time: 90 Days

Secondary Outcomes

Description: Change from initial troponin level to maximum level of troponin among measures taken during hospitalization and at 30 days

Measure: Delta (peak minus baseline) troponin level

Time: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized

Description: Change from baseline BNP level (Day 1) to maximum level of BNP among measures taken during hospitalization and at 30 days

Measure: Delta (baseline to peak) brain natriuretic peptide (BNP) level

Time: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized

Description: Number of participants experiencing LVEF of < 50% on echocardiogram with failure to show an improvement of ≥ 5% at 30 days

Measure: Change in left ventricular ejection fraction (LVEF) on echocardiography

Time: Baseline, Day 30

Measure: Delta (peak minus baseline) C-Reactive protein (CRP) inflammatory biomarker level

Time: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized

Description: D-Dimer is a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis, so named because it contains two D fragments of the fibrin protein joined by a cross-link

Measure: Delta (peak minus baseline) D-Dimer inflammatory biomarker level

Time: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized

Measure: Time (days) to primary endpoint

Time: up to 90 days

Measure: Number of participants requiring mechanical ventilation

Time: 90 days

Measure: Number of participants requiring mechanical circulatory support (MCS)

Time: 90 days

Description: Number of participants released and re-admitted to the hospital within 90 days of enrollment

Measure: Re-hospitalization at 90 days

Time: 90 days

Measure: All-cause mortality

Time: 90 days

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

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 .

NCT04360980 COVID-19 Drug: Colchicine Tablets
MeSH:Infection

Primary Outcomes

Description: increasing inflammatory status

Measure: CRPxN/R ratio change

Time: 2 weeks

Description: including change in fever or O2 Saturation

Measure: Clinical deterioration by the WHO definition

Time: 2 weeks

Description: change in RT-PCR

Measure: PCR Viral Load

Time: 2 weeks

Description: change in CT involvement

Measure: CT severity involvement index

Time: 2weeks

Secondary Outcomes

Description: change in LDH

Measure: LDH change

Time: 2 weeks


No related HPO nodes (Using clinical trials)