COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19 (COMBATCOVID19)
![]() |
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04363437 |
Recruitment Status :
Terminated
(Stopped due to widespread corticosteroid use in 2020 for COVID infection, which confounds and likely supercedes the effect of colchicine.)
First Posted : April 27, 2020
Results First Posted : February 18, 2022
Last Update Posted : February 18, 2022
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
The most prevalent complication of COVID-19 infection is respiratory failure from severe acute respiratory syndrome (SARS), the leading cause of mortality. There is increasing indication that the decompensation in severe COVD-19 infection may be due to a cytokine storm syndrome. This hyperinflammatory syndrome results in a fulminant and fatal hypercytokinemia and multiorgan failure.
Approximately 15% of patients with COVID-19 infection are hospitalized and 20-30% of these hospitalized patients require ICU care and/or mechanical ventilation. Overall mortality in hospitalized patients is approximately 20-25%. There is significant interest in therapies that can be given upstream to reduce the rate of mechanical ventilation and thus mortality.
We hypothesize that treatment with colchicine in COVID-19 moderate-severe patients may decrease the risk of progression into ARDS requiring increased oxygen requirements, mechanical ventilation, and mortality.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronavirus Infection | Drug: Colchicine Drug: Usual Care | Phase 2 |
Prospective, completely randomized, open labeled, controlled study. Patients will be randomized into two groups (A and B). Patients of group A will be treated under what is considered current standard of care at Maimonides Medical Center while group B patients will receive colchicine in addition to standard of care.
Treatment arm
In addition to the local standard of care for COVID 19 patients, the patient will receive colchicine PO as such:
- Loading dose of 1.2 mg followed by 0.6mg after 2 hours if without significant gastrointestinal symptoms (day 1)
- The next day 0.6mg bid for 14 days or until discharge
Patients who are on HMG-Co A Reductase Inhibitors (atorvastatin, fluvastatin, pravastatin, simvastatin), fibrates, genfibrozil, amiodarone, dronedarone or digoxin should have the colchicine dosage reduced to a loading dose of 0.6mg followed by 0.3mg after two hours (day 1) followed by 0.3mg BID for 14 days or until discharge.
If patients have significant gastrointestinal symptoms after loading, the dosage may be reduced to 0.3mg BID for the rest of the 14 day course or until discharge. If gastrointestinal symptoms continue, the medication should then be discontinued. Patients who experience sensory motor neuropathy, or symptoms and laboratory findings consistent with rhabdomyolysis should prompt immediate discontinuation of the drug. If renal function deteriorates during the treatment course and CrCl <30ml/min, colchicine should also be discontinued.
Control arm Usual medical therapy (can include medications such as hydroxychloroquine, azithromycin)
Patients should NOT receive, Remdesivir, IL-6 inhibitors (Tociluzimab, Sarilumab), JAK inhibitors, IL-1 inhibitors, or other immunomodulators for COVID-19 before randomization. Since the primary clinical endpoint is progression of disease, if the patient requires beyond 8L nasal cannula, eg. high flow O2 or mechanical ventilation, the primary clinical endpoint is met and the above experimental medications will be permitted. To rephrase, the patient will be allowed, Remdesivir, IL-6 inhibitors and other immunomodulators if then deemed medically necessary by the treating physician.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19 (the COMBAT-COVID-19 Pilot Study) |
Actual Study Start Date : | April 26, 2020 |
Actual Primary Completion Date : | July 31, 2020 |
Actual Study Completion Date : | July 31, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Colchine |
Drug: Colchicine
People in the colchine group will be given a starting dose of 1.2 mg followed, by 0.6mg after 2 hours if they do not have significant gastrointestinal symptoms, on day 1. After that, they will take colchicine 0.6mg twice a day for 14 days or until discharged or release from the hospital. |
Active Comparator: Usual Care |
Drug: Usual Care
COVID Patients in this arm will receive usual care COVID19 treatment and will not receive colchine. |
- Percentage of Patients Requiring Supplemental Oxygen Beyond 8L Nasal Cannula [ Time Frame: through study completion, estimated 2 months ]
- Percentage of Patients Who Will Require Mechanical Ventillation [ Time Frame: through study completion, estimated 2 months ]
- Mortality [ Time Frame: through study completion, estimated 2 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- Males and females >=18 years of age
- Willing and able to provide written informed consent prior to performing study procedures
- Currently hospitalized and requiring medical care for COVID-19
- Significant COVID-19 symptom, or judged by the treating provider to be at high risk of progression to severe COVID-19 infection
-
Significant COVID-19 symptoms are defined by one or more of the following:
- Dyspnea
- Respiratory frequency ≥ 30/min
- Blood oxygen saturation ≤ 93%
- AND one or more of the following: (positive PCR test or positive antibodies) or (CT/Chest X-ray consistent with COVID19 infection) or (anosmia).
Exclusion Criteria:
- Requirement of oxygen supplementation >8L nasal cannula
- Pregnancy
- Known hypersensitivity to colchicine
- Patient currently in shock or with hemodynamic instability requiring pressors
- History of cirrhosis
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5X upper limit of normal (ULN)
- Patients with severe renal disease, CrCl <30ml/min
- Patients requiring invasive mechanical ventilation at screening or Clinical estimation that the patient will require mechanical respiratory support within 24 hours
- Patient is currently taking colchicine for other indications (gout or Familial Mediterranean Fever)
- Patient received Remdesivir, Sarilumab, Tociluzimab, Lopinavir/Ritonavir or other immunomodulator given for COVID-19 treatment (Note: Convalescent plasma infusion is not an exclusion)
- Patient is on (and cannot discontinue) a strong CYP3A4 inhibitor (eg clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, atazanavir), a moderate CYP3A4 inhbitor (eg diltiazem, verapamil, fluconazole, amprenavir, aprepitant, fosamprenavir) or a P-gp Inhibitor (eg cyclosporine, ranolazine)
- Patient is undergoing chemotherapy for cancer
- Patient is considered by the investigator, for any reason, to be unsuitable candidate for the study

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): NCT04363437
United States, New York | |
Maimonides Medical Center | |
Brooklyn, New York, United States, 11219 |
Principal Investigator: | Felix Yang, MD | Maimonides Medical Center |
Documents provided by Maimonides Medical Center:
Responsible Party: | Maimonides Medical Center |
ClinicalTrials.gov Identifier: | NCT04363437 |
Other Study ID Numbers: |
2020-04-12 |
First Posted: | April 27, 2020 Key Record Dates |
Results First Posted: | February 18, 2022 |
Last Update Posted: | February 18, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
colchicine anti-inflammatory |
Coronavirus Infections Infections Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Colchicine |
Gout Suppressants Antirheumatic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |