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NCT05689034
Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adults With COVID-19 at Increased Risk of Progressing to Severe Illness
Phase 2, PHASE3 trial testing Azvudine in COVID-19 Respiratory Infection in 1,096 participants. Currently enrolling.
30 June 2025
Quick facts
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 1,096 |
| Start date | 19 April 2023 |
| Primary completion | 30 June 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Azvudine — full drug profile →
- Placebo
Conditions studied
- COVID-19 Respiratory Infection — all drugs for COVID-19 Respiratory Infection →
Sponsor
Peking Union Medical College Hospital
Who can join
Adults 18 to 120, any sex, with COVID-19 Respiratory Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To investigate whether treatment with Azvudine reduces the risk of severe illness or death in patients who are at a potential risk of progressing to severe COVID-19 infection.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Efficacy and safety of azvudine in patients with COVID-19: A systematic review and meta-analysis.
Chen Z, Tian F. · · 2023 · cited 19× · PMID 37809649 · DOI 10.1016/j.heliyon.2023.e20153 -
Efficacy and safety of azvudine in symptomatic adult COVID-19 participants who are at increased risk of progressing to critical illness: a study protocol for a multicentre randomized double-blind placebo-controlled phase III trial.
Tian X, Xu Y, Wang L, Dong C, et al · · 2024 · cited 1× · PMID 38254211 · DOI 10.1186/s13063-024-07914-3 -
Real-World Evaluation Study of Azvudine for the Treatment of Patients With COVID-19: A Systematic Review and Meta-Analysis.
Kapar A, Li H, He Q, Lin D, et al · · 2025 · PMID 41050344 · DOI 10.1155/cjid/3645253
Verify or expand the search:
- PubMed search for NCT05689034
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Azvudine
Trials testing the same drug.
- NCT06349655 — The Real-world Clinical Study of Azvudine Tablets in the Treatment of COVID-19 · completed
- NCT06006611 — Risk Factors for Severe Disease in Hospitalized Patients With COVID-19 and the Effect of Azvudine Treatment: a Retrospec · unknown
- NCT05697055 — A Study of Efficacy and Safety of Azvudine vs. Nirmatrelvir-Ritonavir in the Treatment of COVID-19 Infection · Phase 4 · unknown
- NCT05675748 — Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients · unknown
- NCT05682599 — Evaluate Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 in China · Phase 2 · unknown
Other recruiting trials for COVID-19 Respiratory Infection
Currently open trials in the same condition.
- NCT06950177 — Pancoronavirus Vaccine Study in Healthy Adults · Phase 1 · active not recruiting
- NCT06402318 — Passive Detection- SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) for Operational Medicine · recruiting
- NCT05765396 — SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies · active not recruiting
- NCT05562505 — Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure · NA · recruiting
- NCT05040659 — Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2 · active not recruiting
Other Peking Union Medical College Hospital trials
Trials by the same sponsor.
- NCT07466251 — PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke · Phase 4 · not yet recruiting
- NCT06743321 — Speech-to-speech Voice-cloning Care (SVCC) to Improve ICU-acquired Anxiety for Critically Ill Patients · NA · not yet recruiting
- NCT07590336 — 68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma · Phase 1, PHASE2 · not yet recruiting
- NCT07515976 — Mapping of Genomic Structural Variations in Major Birth Defects · not yet recruiting
- NCT07386756 — Early Precise Identification and Intervention Strategies for Individuals at High Risk of Prediabetes · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05689034 (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 Peking Union Medical College Hospital
- Last refreshed: 25 November 2024
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/NCT05689034.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing