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NCT04347915
The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19
Completed
Phase 2
Last updated 22 July 2022
What this trial tests
Phase 2 trial testing Clevudine in COVID-19 in 64 participants. Completed in 26 February 2021.
Timeline
26 May 2020
Primary endpoint
24 February 2021
24 February 2021
26 February 2021
Quick facts
| Lead sponsor | Bukwang Pharmaceutical |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 26 May 2020 |
| Primary completion | 24 February 2021 |
| Estimated completion | 26 February 2021 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Clevudine (CLEVUDINE) — full drug profile →
- Placebo
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
Bukwang Pharmaceutical — full company profile →
Who can join
19 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this clinical trial is to assess the safety and efficacy of Clevudine 120 mg versus placebo once daily administration with standard of care therapy for 14 days (maximum up to 21 days) in patients with moderate COVID-19.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102 -
Potential therapeutic targets for combating SARS-CoV-2: Drug repurposing, clinical trials and recent advancements.
Pandey A, Nikam AN, Shreya AB, Mutalik SP, et al · · 2020 · cited 80× · PMID 32497632 · DOI 10.1016/j.lfs.2020.117883 -
Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895 -
Neuropathophysiology of coronavirus disease 2019: neuroinflammation and blood brain barrier disruption are critical pathophysiological processes that contribute to the clinical symptoms of SARS-CoV-2 infection.
Welcome MO, Mastorakis NE. · · 2021 · cited 50× · PMID 33822324 · DOI 10.1007/s10787-021-00806-x -
Outbreak of COVID-19: An emerging global pandemic threat.
Peng M. · · 2020 · cited 42× · PMID 32768974 · DOI 10.1016/j.biopha.2020.110499 -
Novel therapeutic approaches for treatment of COVID-19.
Hossein-Khannazer N, Shokoohian B, Shpichka A, Aghdaei HA, et al · · 2020 · cited 36× · PMID 32494931 · DOI 10.1007/s00109-020-01927-6 -
Placental transfer and safety in pregnancy of medications under investigation to treat coronavirus disease 2019.
Louchet M, Sibiude J, Peytavin G, Picone O, et al · · 2020 · cited 34× · PMID 32838264 · DOI 10.1016/j.ajogmf.2020.100159 -
Potential Anti-SARS-CoV-2 Therapeutics That Target the Post-Entry Stages of the Viral Life Cycle: A Comprehensive Review.
Al-Horani RA, Kar S. · · 2020 · cited 33× · PMID 32993173 · DOI 10.3390/v12101092
Verify or expand the search:
- PubMed search for NCT04347915
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other trials of Clevudine
Trials testing the same drug.
- NCT04891302 — The Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Mild and Moderate C · Phase 2 · completed
Other recruiting trials for COVID-19
Currently open trials in the same condition.
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- NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
- NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
- NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
- NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting
Other Bukwang Pharmaceutical trials
Trials by the same sponsor.
- NCT06014853 — A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SOL-804 in Healthy Male Subjects · Phase 1 · completed
- NCT04377945 — Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components · Phase 2 · terminated
- NCT04891302 — The Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Mild and Moderate C · Phase 2 · completed
- NCT03465787 — A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04347915 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bukwang Pharmaceutical
- Last refreshed: 22 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04347915.
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