Trial · NCT04756128
Impact of Colchicine and Low-dose Naltrexone on COVID-19
NCT04756128, Phase 2, Completed, HealthPartners Institute; results first posted 2023-07-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Impact of Colchicine and Low-dose Naltrexone on COVID-19. Trials, record NCT04756128. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04756128
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Colchicine and Low-dose Naltrexone on COVID-19
- NCT number
- NCT04756128
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 142 participants, actual
- Lead sponsor
- HealthPartners Institute
- Conditions
- Covid19
- Interventions
- Colchicine 0.6 mg, Naltrexone
- First posted
- 2021-02-16
- Last updated
- 2023-07-25
- Results first posted
- 2023-07-25
- Limitations and caveats
Limitations include use of a SOC control in place of placebo given the limited time and resources during the COVID-19 surge. Incidence of disease recovery for both study drugs could be impacted by the rapidly improving standard of care for treating patients as the study progressed (remdesivir, glucocorticoids, and tocilizumab).
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | In Patients Hospitalized With Moderate COVID-19, the Impact of Colchicine and LDN, Alone or in Combination, on Achieving Disease Recovery by Day 5. | Assessed from time of hospitalization until (1) 5 days after enrollment, while still hospitalized (or until discharge, which may be less than 5 days) | Disease recovery from moderate COVID-19 was defined as achieving a clinical scale score of 1 (indicating the patient no longer required hospital-level care for COVID-19. Attainment of a score of 1 by study day 5 was chosen based on initial experience treating COVID-19 within this specific health system-patients with similar disease severity were typically hospitalized for 6-7 days, and time from admission to enrollment in preceding COVID-19 studies was generally 1-2 days. |
| Secondary | Total Duration of Hospitalization | Assessed from time of hospitalization until discharge, calculated after patient completes hospital stay - approximately 7 days on average | Study team will investigate the effects of colchicine and LDN, alone or in combination, on total amount of time (in days) patient spent in hospital from admission to discharge |
| Secondary | Total Duration of Hospitalization (From First Dose of Study Drug to Discharge) | Assessed from time of study drug administration to discharge, calculated after patient completes hospital stay; 7 days after admission on average) | Study team will investigate the effects of colchicine and LDN, alone or in combination, on total amount of time (in days) patient spent in hospital from first dose of any study medication (or when first dose would be given for standard of care arm) to hospital discharge (or when ready for discharge but remains hospitalized for non-medical reasons \[e.g. transitional care unit placement delays\]) |
| Secondary | In Patients Hospitalized With Moderate COVID-19, Subjects Who Required Remdesivir | Assessed from time of study drug administration to discharge, calculated after patient completes hospital stay; 7 days after admission on average) | Study team will investigate the effects of colchicine and LDN, alone or in combination, on requiring remdesivir |
| Secondary | The Number of Doses of Remdesivir Required In Patients Hospitalized With Moderate COVID-19 | Assessed from time of study drug administration to discharge, calculated after patient completes hospital stay; 7 days after admission on average) | Study team will investigate the effects of colchicine and LDN, alone or in combination, on the number of doses of Remdesivir received. This was only used in patients who met/required this outcome (received Remdesiver, n=92) |
| Secondary | In Patients Hospitalized With Moderate COVID-19, Subjects Who Required Corticosteroids | Assessed from time of study drug administration to discharge, calculated after patient completes hospital stay; 7 days after admission on average) | Study team will investigate the effects of colchicine and LDN, alone or in combination, on requiring corticosteroids |
| Secondary | The Dosage Amount (in Milligrams) of Corticosteroids Required In Patients Hospitalized With Moderate COVID-19 | Assessed from time of study drug administration to discharge, calculated after patient completes hospital stay; 7 days after admission on average) | Study team will investigate the effects of colchicine and LDN, alone or in combination, on the amount in milligrams (mg) of corticosteroids required. This was only used in patients who met/required this outcome (received Corticosteroids, n=129) |
| Secondary | In Patients Hospitalized With Moderate COVID-19, The Need for High Flow Nasal Cannula (HFNC) or Non-Invasive Positive Pressure Ventilation (NIPPV) | Assessed from time of study drug administration to discharge, calculated after patient completes hospital stay; 7 days after admission on average) | Study team will investigate the effects of colchicine and LDN, alone or in combination, on the need of oxygen supplementation with High Flow Nasal Cannula (HFNC) or Non-Invasive Positive Pressure Ventilation (NIPPV) |
| Secondary | In Patients Hospitalized With Moderate COVID-19, Patients Who Required ICU or ICU Stepdown Cares | Assessed from time of study drug administration to discharge, calculated after patient completes hospital stay; 7 days after admission on average) | Study team will investigate the effects of colchicine and LDN, alone or in combination, on requiring ICU or Stepdown ICU admission |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | In Patients Hospitalized With Moderate COVID-19, the Impact of Colchicine and LDN, Alone or in Combination, on Achieving Disease Recovery by Day 5. | Assessed from time of hospitalization until (1) 5 days after enrollment, while still hospitalized (or until discharge, which may be less than 5 days) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Total Duration of Hospitalization | Assessed from time of hospitalization until discharge, calculated after patient completes hospital stay - approximately 7 days on average | days | MEDIAN | |
| SECONDARY | Total Duration of Hospitalization (From First Dose of Study Drug to Discharge) | Assessed from time of study drug administration to discharge, calculated after patient completes hospital stay; 7 days after admission on average) | days | MEDIAN | |
| SECONDARY | In Patients Hospitalized With Moderate COVID-19, Subjects Who Required Remdesivir | Assessed from time of study drug administration to discharge, calculated after patient completes hospital stay; 7 days after admission on average) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Number of Doses of Remdesivir Required In Patients Hospitalized With Moderate COVID-19 | Assessed from time of study drug administration to discharge, calculated after patient completes hospital stay; 7 days after admission on average) | doses | MEDIAN | |
| SECONDARY | In Patients Hospitalized With Moderate COVID-19, Subjects Who Required Corticosteroids | Assessed from time of study drug administration to discharge, calculated after patient completes hospital stay; 7 days after admission on average) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Dosage Amount (in Milligrams) of Corticosteroids Required In Patients Hospitalized With Moderate COVID-19 | Assessed from time of study drug administration to discharge, calculated after patient completes hospital stay; 7 days after admission on average) | mg | MEDIAN | |
| SECONDARY | In Patients Hospitalized With Moderate COVID-19, The Need for High Flow Nasal Cannula (HFNC) or Non-Invasive Positive Pressure Ventilation (NIPPV) | Assessed from time of study drug administration to discharge, calculated after patient completes hospital stay; 7 days after admission on average) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | In Patients Hospitalized With Moderate COVID-19, Patients Who Required ICU or ICU Stepdown Cares | Assessed from time of study drug administration to discharge, calculated after patient completes hospital stay; 7 days after admission on average) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| In Patients Hospitalized With Moderate COVID-19, the Impact of Colchicine and LDN, Alone or in Combination, on Achieving Disease Recovery by Day 5. | Colchicine-Only Arm | 22 | Participants | ||
| In Patients Hospitalized With Moderate COVID-19, the Impact of Colchicine and LDN, Alone or in Combination, on Achieving Disease Recovery by Day 5. | Colchicine and Naltrexone (Combined) Arm | 24 | Participants | ||
| In Patients Hospitalized With Moderate COVID-19, the Impact of Colchicine and LDN, Alone or in Combination, on Achieving Disease Recovery by Day 5. | Naltrexone-Only Arm | 20 | Participants | ||
| In Patients Hospitalized With Moderate COVID-19, the Impact of Colchicine and LDN, Alone or in Combination, on Achieving Disease Recovery by Day 5. | Standard of Care Arm | 18 | Participants | ||
| In Patients Hospitalized With Moderate COVID-19, the Impact of Colchicine and LDN, Alone or in Combination, on Achieving Disease Recovery by Day 5. | Colchicine Group | 46 | Participants | ||
| In Patients Hospitalized With Moderate COVID-19, the Impact of Colchicine and LDN, Alone or in Combination, on Achieving Disease Recovery by Day 5. | No Colchicine Group | 38 | Participants | ||
| In Patients Hospitalized With Moderate COVID-19, the Impact of Colchicine and LDN, Alone or in Combination, on Achieving Disease Recovery by Day 5. | Naltrexone Group | 44 | Participants | ||
| In Patients Hospitalized With Moderate COVID-19, the Impact of Colchicine and LDN, Alone or in Combination, on Achieving Disease Recovery by Day 5. | No Naltrexone Group | 40 | Participants | ||
| Total Duration of Hospitalization | Colchicine-Only Arm | 4.5 | Inter-Quartile Range 3 to 8 | days | |
| Total Duration of Hospitalization | Colchicine and Naltrexone (Combined) Arm | 4.7 | Inter-Quartile Range 4 to 6 | days |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Colchicine-Only Arm | 35 | |
| Overall Study | STARTED | Colchicine and Naltrexone (Combined) Arm | 35 | |
| Overall Study | STARTED | Naltrexone-Only Arm | 36 | |
| Overall Study | STARTED | Standard of Care Arm | 36 | |
| Overall Study | COMPLETED | Colchicine-Only Arm | 34 | |
| Overall Study | COMPLETED | Colchicine and Naltrexone (Combined) Arm | 33 | |
| Overall Study | COMPLETED | Naltrexone-Only Arm | 35 | |
| Overall Study | COMPLETED | Standard of Care Arm | 35 | |
| Overall Study | NOT COMPLETED | Colchicine-Only Arm | 1 | |
| Overall Study | NOT COMPLETED | Colchicine and Naltrexone (Combined) Arm | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea/Loose Stools/Incontinence | Gastrointestinal disorders | Colchicine-Only Arm | 4 | 34 | |
| other | Diarrhea/Loose Stools/Incontinence | Gastrointestinal disorders | Colchicine and Naltrexone (Combined) Arm | 4 | 33 | |
| other | Diarrhea/Loose Stools/Incontinence | Gastrointestinal disorders | Naltrexone-Only Arm | 2 | 35 | |
| other | Diarrhea/Loose Stools/Incontinence | Gastrointestinal disorders | Standard of Care Arm | 7 | 35 | |
| other | Dizziness | General disorders | Colchicine-Only Arm | 1 | 34 | |
| other | Dizziness | General disorders | Colchicine and Naltrexone (Combined) Arm | 3 | 33 | |
| other | Dizziness | General disorders | Naltrexone-Only Arm | 0 | 35 | |
| other | Dizziness | General disorders | Standard of Care Arm | 0 | 35 | |
| other | Nausea/Stomach Pain/Vomiting | Gastrointestinal disorders | Colchicine-Only Arm | 4 | 34 | |
| other | Nausea/Stomach Pain/Vomiting | Gastrointestinal disorders | Colchicine and Naltrexone (Combined) Arm | 4 | 33 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Colchicine-Only Arm | 0 | 34 |
| Total, all-cause mortality | Colchicine and Naltrexone (Combined) Arm | 1 | 33 |
| Total, all-cause mortality | Naltrexone-Only Arm | 4 | 35 |
| Total, all-cause mortality | Standard of Care Arm | 0 | 35 |
| Total, other adverse events | Colchicine-Only Arm | 13 | 34 |
| Total, other adverse events | Colchicine and Naltrexone (Combined) Arm | 19 | 33 |
| Total, other adverse events | Naltrexone-Only Arm | 13 | 35 |
| Total, other adverse events | Standard of Care Arm | 14 | 35 |
| Total, serious adverse events | Colchicine-Only Arm | 4 | 34 |
| Total, serious adverse events | Colchicine and Naltrexone (Combined) Arm | 6 | 33 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04756128
GET https://conductscience.org/api/trials/v1/NCT04756128/results?page=2