Colchicine in COVID-19: a Pilot Study (COLVID-19)
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ClinicalTrials.gov Identifier: NCT04375202 |
Recruitment Status :
Terminated
(Insufficient rate of patient accrual and newly available scientific evidence)
First Posted : May 5, 2020
Last Update Posted : November 7, 2022
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: Colchicine 1 MG Oral Tablet | Phase 2 |
This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care versus current care.
One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint. Secondary objectives are trend of White blood cell count, Change of the "Sequential Organ failure Assessment" (SOFA), Rate of biochemical criterion (CK, ALT,ferritin) recovery, Rate of disease remission and safety of Colchicine.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 227 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment With COLchicine of Patients Affected by COVID-19: a Pilot Study |
Actual Study Start Date : | April 18, 2020 |
Actual Primary Completion Date : | October 31, 2021 |
Actual Study Completion Date : | October 31, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Colchicine plus current care
Colchicine 0.5 mg three times a day if weight is less than 100 kg; 1 mg twice a day if weight is more than 100 kg for 30 days or up to discharge. Reduce based on gastrointestinal symptoms appearance at discretion of the Investigator.
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Drug: Colchicine 1 MG Oral Tablet
Tablets for oral administration, containing 1 mg of the active ingredient colchicine, administered 0.5 mg po every 8 hours x 30 days. |
No Intervention: Current care alone
Current care
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- Rate of entering the critical stage [ Time Frame: [1 month] ]
Comply with any of the followings:
- Respiratory failure occurs and requires mechanical ventilation;
- Patients combined with other organ failure need ICU monitoring and treatment
- Death
- Trend of White blood cell count [ Time Frame: [up to 30 days] ]
- Change of the "Sequential Organ failure Assessment" (SOFA) [ Time Frame: [up to 30 days] ]
- Rate of biochemical criterion (CK, ALT, ferritin) recovery [ Time Frame: [up to 30 days] ]
- Rate of disease remission [ Time Frame: [up to 30 days] ]
Comply with any of the followings:
- No fever, cough and other symptoms;
- SPO2>94% or PaO2/FiO2 >350mmHg without oxygen inhalation

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Informed consent for participation in the study
- Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
- Hospitalized due to clinical/instrumental diagnosis of pneumonia
- Oxygen saturation at rest in ambient air ≤94%
- PaO2/FiO2 ratio of 350 to 200
Exclusion Criteria:
- Known hypersensitivity to colchicine or its excipients
- Severe diarrhea
- Patients who cannot take oral therapy
- Pregnant and lactating patients
- Patients with severe cardiac, renal insufficiency (creatinine clearance (CCL) <30 mL / min)
- Patients with kidney or liver damage [(AST or ALT> 5 times the normal limits in International Units (ULN)]; or are taking CYP3A4 enzyme - P glycoprotein inhibitors.
- Known other clinical condition that contraindicates colchicine and cannot be treated or solved according to the judgement of the clinician
- Neutrophils <1.000 / mmc
- Platelets <50.000 / mmc
- Bowel diverticulitis or perforation
- Patients already in ICU or requiring mechanical ventilation
- Patients receiving Tocilizumab
- Patients already enrolled in other clinical trials

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): NCT04375202
Italy | |
Associazione Italiana Pneumologi Ospedalieri | |
Milan, Italy | |
Società Italiana di Reumatologia | |
Milan, Italy |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Prof Roberto Gerli, Principal Investigator, University Of Perugia |
ClinicalTrials.gov Identifier: | NCT04375202 |
Other Study ID Numbers: |
2020-001475-33 |
First Posted: | May 5, 2020 Key Record Dates |
Last Update Posted: | November 7, 2022 |
Last Verified: | November 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID COVID-19 CORONAVIRUS |
SARS-COV-2 COLCHICINE IL-1 |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections |
Lung Diseases Respiratory Tract Diseases Colchicine Gout Suppressants Antirheumatic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |