NCT05656443 is a Phase 2, PHASE3 clinical trial of GST-HG171/Ritonavir in COVID-19 Pneumonia, sponsored by Fujian Akeylink Biotechnology Co., Ltd..

Who is sponsoring NCT05656443?

NCT05656443 is sponsored by Fujian Akeylink Biotechnology Co., Ltd..

What drugs are being tested in NCT05656443?

Interventions in NCT05656443: GST-HG171/Ritonavir, Placebo.

What condition does NCT05656443 study?

NCT05656443 studies COVID-19 Pneumonia.

Is NCT05656443 still recruiting?

NCT05656443 is currently completed. Last updated 12 October 2023.

Last reviewed 2023-10-12 · How we verify

NCT05656443

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of GST-HG171/Ritonavir Compared With Placebo in Patients With Mild to Moderate COVID-19

Completed Phase 2, PHASE3 Last updated 12 October 2023

What this trial tests

Phase 2, PHASE3 trial testing GST-HG171/Ritonavir in COVID-19 Pneumonia in 1,246 participants. Completed in 14 July 2023.

Timeline

19 December 2022

Primary endpoint
31 May 2023

14 July 2023

Quick facts

Lead sponsor	Fujian Akeylink Biotechnology Co., Ltd.
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,246
Start date	19 December 2022
Primary completion	31 May 2023
Estimated completion	14 July 2023
Sites	1 location across China

Drugs / interventions tested

GST-HG171/Ritonavir — full drug profile →
Placebo

Conditions studied

COVID-19 Pneumonia — all drugs for COVID-19 Pneumonia →

Sponsor

Fujian Akeylink Biotechnology Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with COVID-19 Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of GST-HG171/Ritonavir in the treatment of mild to moderate COVID-19.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Inhibitors of SARS-CoV-2 Main Protease (Mpro) as Anti-Coronavirus Agents.
Zagórska A, Czopek A, Fryc M, Jończyk J. · · 2024 · cited 19× · PMID 39062511 · DOI 10.3390/biom14070797
Efficacy and safety of GST-HG171 in adult patients with mild to moderate COVID-19: a randomised, double-blind, placebo-controlled phase 2/3 trial.
Lu H, Zhang G, Mao J, Chen X, et al · · 2024 · cited 15× · PMID 38618202 · DOI 10.1016/j.eclinm.2024.102582
Therapeutic developments for SARS-CoV-2 infection-Molecular mechanisms of action of antivirals and strategies for mitigating resistance in emerging variants in clinical practice.
Săndulescu O, Apostolescu CG, Preoțescu LL, Streinu-Cercel A, et al · · 2023 · cited 7× · PMID 36937282 · DOI 10.3389/fmicb.2023.1132501
Research Progress on the Structure and Function, Immune Escape Mechanism, Antiviral Drug Development Methods, and Clinical Use of SARS-CoV-2 M<sup>pro</sup>.
Ren J, Zhang Z, Xia Y, Zhao D, et al · · 2025 · PMID 39860219 · DOI 10.3390/molecules30020351

Verify or expand the search:

Other trials of GST-HG171/Ritonavir

Trials testing the same drug.

NCT06087055 — Drug-Drug Interaction Study of Itraconazole With GST-HG171/Ritonavir in Healthy Participants · Phase 1 · completed

Other recruiting trials for COVID-19 Pneumonia

Currently open trials in the same condition.

NCT06601998 — Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19. · recruiting
NCT06501599 — AI-based System for Assessing Suspected Viral Pneumonia Related Lung Changes · 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
NCT06927622 — Corona Virus Disease 2019 Cohort Study · recruiting

Other Fujian Akeylink Biotechnology Co., Ltd. trials

Trials by the same sponsor.

NCT07090759 — To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) · Phase 3 · recruiting
NCT06263959 — A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 · Phase 2 · recruiting
NCT06087055 — Drug-Drug Interaction Study of Itraconazole With GST-HG171/Ritonavir in Healthy Participants · Phase 1 · completed
NCT06084507 — Food Effects of GST-HG171 Tablets Combined With Ritonavir in Healthy Chinese Participants · Phase 1 · unknown
NCT06106126 — Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Renal Function · NA · unknown

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 NCT05656443 (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 Fujian Akeylink Biotechnology Co., Ltd.
Last refreshed: 12 October 2023

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/NCT05656443.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing