Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04756128 · ClinicalTrials.gov registry record · Phase 2
Impact of Colchicine and Low-dose Naltrexone on COVID-19
A Phase 2 study of Covid19, sponsored by HealthPartners Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 142
- Enrollment target
- 2
- Study locations
NCT04756128 is a Phase 2 study of Covid19 that has completed, run by HealthPartners Institute. The registered enrollment target is 142 participants, below the 2,701-participant average among 94 other Covid19 trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT04756128, a Phase 2 study of Covid19, has completed, sponsored by HealthPartners Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 142 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to explore the impact of two medications-colchicine and low-dose naltrexone (LDN)-relative to standard of care (SOC) on COVID-19 disease progression to severe/critical illness and/or intubation in patients hospitalized with moderate COVID-19. As researchers have learned, COVID-19's clinical course suggests that the hyperinflammatory response seen in severe/critical cases is involved in the pathogenesis of associated adverse sequelae such as acute respiratory distress syndrome (ARDS), thromboembolic disease, and acute cardiac injury. Given colchicine has demonstrated clinical utility in inflammatory syndromes within these systems (e.g. endothelial/vascular/myocardial), and LDN acts both to boost the immune system, and limit an excessive response; they may prove useful in minimizing the risk of disease progression and associated adverse sequelae.
Conditions Studied
Interventions
- DRUG Colchicine 0.6 mg
- DRUG Naltrexone
Study Locations (2)
Minnesota
- Park Nicollet Methodist Hospital - Saint Louis Park
- Regions Hospital - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2021-01-25 |
| Est. Completion | 2021-12-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04756128
The ClinicalTrials.gov registry entry for NCT04756128 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,701-participant average among 94 other Covid19 trials with a reported enrollment target (95% lower). The listed sponsor is HealthPartners Institute, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Covid19 appearing as the primary indexed condition, and to 2 interventions - of which Colchicine 0.6 mg is the first listed.
NCT04756128 reports 2 study locations spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT04756128 about?
NCT04756128 is a clinical study titled "Impact of Colchicine and Low-dose Naltrexone on COVID-19". The purpose of this study is to explore the impact of two medications-colchicine and low-dose naltrexone (LDN)-relative to standard of care (SOC) on COVID-19 disease progression to severe/critical illness and/or intubation in patients hospitalized with moderate COVID-19. As researchers have learned,...
What is the current status of trial NCT04756128?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2021-01-25. Estimated completion is 2021-12-12.
What conditions does trial NCT04756128 study?
This clinical trial studies the following conditions: Covid19.
What interventions are being tested in trial NCT04756128?
The interventions under investigation include: Colchicine 0.6 mg (DRUG), Naltrexone (DRUG).
Who is sponsoring clinical trial NCT04756128?
This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04756128 being conducted?
This trial has 2 study locations across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Covid19
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Imaging Immune Activation in COVID-19
RECRUITING · Phase 2
-
Phase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
RECRUITING · Phase 2
-
Defibrotide for the Treatment of Severe COVID-19
RECRUITING · Phase 2
-
SARS-Cov-2 (COVID-19) Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial
ACTIVE NOT RECRUITING · Phase 2
-
COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation
ACTIVE NOT RECRUITING · Phase 2
-
A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults
ACTIVE NOT RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.