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NCT04859244
First-in-Human Study of Orally Administered GS-441524 for COVID-19
Phase 1 trial testing GS-441524 in COVID-19 in 1 participant. Completed in 1 August 2021.
1 May 2021
Quick facts
| Lead sponsor | Copycat Sciences LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 1 January 2021 |
| Primary completion | 1 May 2021 |
| Estimated completion | 1 August 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- GS-441524 — full drug profile →
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
Copycat Sciences LLC
Who can join
18 and older, female only, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a two-part study is to evaluate the multi-day safety, tolerability, and pharmacokinetics (PK) of orally administered GS-441524 in a healthy human volunteer.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Co-administration of Favipiravir and the Remdesivir Metabolite GS-441524 Effectively Reduces SARS-CoV-2 Replication in the Lungs of the Syrian Hamster Model.
Chiba S, Kiso M, Nakajima N, Iida S, et al · · 2021 · cited 22× · PMID 35100870 · DOI 10.1128/mbio.03044-21 -
Recent Updates in Experimental Research and Clinical Evaluation on Drugs for COVID-19 Treatment.
Zou H, Yang Y, Dai H, Xiong Y, et al · · 2021 · cited 12× · PMID 34880750 · DOI 10.3389/fphar.2021.732403 -
The Potential Protective Role of GS-441524, a Metabolite of the Prodrug Remdesivir, in Vaccine Breakthrough SARS-CoV-2 Infections.
Zhu J, Li Y, Liang J, Mubareka S, et al · · 2022 · cited 1× · PMID 36407474 · DOI 10.1007/s44231-022-00021-4
Verify or expand the search:
- PubMed search for NCT04859244
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04859244 (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 Copycat Sciences LLC
- Last refreshed: 10 August 2021
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/NCT04859244.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing