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NCT04756128 · ClinicalTrials.gov registry record · Phase 2
Impact of Colchicine and Low-dose Naltrexone on COVID-19
A Phase 2 study of COVID-19, sponsored by HealthPartners Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 142
- Enrollment target
- 2
- Study locations
NCT04756128: Completed Phase 2 study of COVID-19, sponsored by HealthPartners Institute.
NCT04756128 is a Phase 2 study of COVID-19 that has completed, run by HealthPartners Institute. The registered enrollment target is 142 participants, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04756128, a Phase 2 study of COVID-19, 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.
Primary Outcome
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.
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 |
What the finished NCT04756128 record still lists
NCT04756128 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Colchicine 0.6 mg is the first listed.
NCT04756128 reports a single indexed study location in 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: COVID-19.
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
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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.
Where NCT04756128's enrollment target sits among peer trials
142 180th of 298 higher than 119 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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