COVID-19 PneumoniaPhase 2/3NCT05656443
Study of GST-HG171/Ritonavir Compared With Placebo in Patients With Mild to Moderate COVID-19
A Phase 2/3 study testing GST-HG171/Ritonavir in people with COVID-19 Pneumonia, run by Fujian Akeylink Biotechnology Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- GST-HG171/Ritonavir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,246 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2022to 14 Jul 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥ 18 years when signing the informed consent form (ICF);
- Subjects with reverse transcription-polymerase chain reaction (RT-PCR) test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in specimens such as nasopharyngeal swabs/oropharyngeal swabs for the first time within 4 days prior to randomization who meet the diagnostic and treatment criteria for mild and moderate cases in the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9) issued by the National Health Commission of the Peoples Republic of China ;
- RT-PCR result of N gene or ORF gene of SARS-CoV-2 within 48 hours before randomization shows a Ct value < 35; at least 2 COVID-19 target symptoms appeared for the first time within 72 hours before randomization (COVID-19 target symptoms include fever, cough, stuffy or runny nose, sore throat or dry throat, shortness of breath or difficulty breathing, headache, muscle or body aches, diarrhoea, chills, nausea, and vomit), including at least one designated symptom: fever, cough, stuffy or runny nose, sore throat or dry throat, shortness of breath or difficulty breathing;
- Women of childbearing potential must have a negative serum pregnancy test during the screening period. Subjects should take effective contraceptive measures throughout the study period since signing the informed consent form and for 28 days after the end of the study;
- Subjects who are able to understand the study procedures and methods, and voluntarily participate in the study and sign the ICF after being fully informed.
Who cannot join
- Subjects who are known to have hypersensitivity to any component of the investigational drug;
- Subjects who meet diagnostic and treatment criteria for severe and critical cases in the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 10) issued by National Health Commission of the People's Republic of China;
- Abnormal hepatic function at screening: total bilirubin ≥ 1.5 × upper limit of normal (ULN); ALT or AST ≥ 3 × ULN;
- Human immunodeficiency virus (HIV) antibody positive, treponema pallidum-specific antibody (TP-PA) positive or rapid plasma reagin (RPR) positive for syphilis at screening;
- Abnormal renal function at screening: serum creatinine ≥ 1.5 × ULN;
- Subjects with impaired immune system (including those treated with corticosteroids* or other immunosuppressants*, or those with progression or recurrence of cancer) at screening; Note: *Patients using skin preparations are allowed to be enrolled, but the skin preparations cannot be used in the eyes, nose or ears or by inhalation.
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- Acute onset of chronic respiratory diseases, including bronchial asthma and chronic obstructive pulmonary disease at screening;
- There are suspected or confirmed acute systemic infections except for COVID-19 at the time of screening (for example, the pathogen detection indicates that it is complicated with influenza; there is a high possibility of bacterial infection as indicated by symptoms, signs, laboratory tests or imaging), which may interfere with the assessment of response to study intervention;
- Any comorbidity requiring surgery within 14 days prior to randomization or during the study, or any life-threatening comorbidity within 30 days prior to randomization as determined by the investigator;
- Subjects who are receiving HIV antiviral treatment at screening;
- Treatment with SARS-CoV-2 antiviral drugs within 14 days prior to randomization;
- Subjects who have received (within 30 days prior to randomization or within 5 drug half-lives, whichever is longer) or are expected to receive COVID-19 monoclonal antibody, intravenous injection of COVID-19 human immunoglobulin, or COVID-19 convalescent plasma therapy;
- Subjects who have received any COVID-19 vaccine within 28 days prior to randomization or planned to receive any COVID-19 vaccine during the study;
- Any drug prohibited by the package insert of Paxlovid that is currently used or expected to be used during treatment and within 4 days after the last dose of study drug, or any other drug or substance that is highly dependent on cytochrome P450 (CYP) 3A4, CYP2B6, CYP1A2, multidrug resistance gene 1 (MDR1) or organic anion transporting polypeptide (OATP) 1B3 for clearance; any potent CYP3A4 or MDR1 inducers used within 28 days prior to randomization or expected to be used during treatment and within 4 days after the last dose of study drug ;
- Pregnant or lactating women;
- Subjects who have participated in other clinical trials within 3 months prior to administration or are receiving other investigational drugs;
- Subjects with other conditions that, in the judgment of the investigator, make them unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of GST-HG171/Ritonavir in Patients With Mild to Moderate COVID-19
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.
- Conditions
- COVID-19 Pneumonia
- Being tested
- GST-HG171/Ritonavir, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GST-HG171/RitonavirDrug
dose of 150 mg GST-HG171 with 100 mg ritonavir
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| GST-HG171/Ritonavir | Experimental | Not described Receives: Drug: GST-HG171/Ritonavir |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to sustained clinical recovery of 11 COVID-19 symptoms
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for two consecutive days
Measured: Day 1 through Day 28
Secondary outcomes (5)
Viral load
Change of viral load compared to the baseline
Measured: Baseline through Day 5
Time to sustained clinical recovery of 5 COVID-19 symptoms
The time from the start of treatment to the time when respiratory and feverish symptoms get scores of 0 for two consecutive days
Measured: Day 1 through Day 28
Time to sustained alleviation of 11 COVID-19 symptoms
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 or 1 for two consecutive days
Measured: Baseline through Day 28
Proportion of participants in clinical recovery
Proportion of participants in clinical recovery
Measured: Day 1 through Day 28
AE
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Day 1 through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start19 Dec 2022
- Primary completion31 May 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Akeylink Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656443
- Sponsor's protocol ID
- GST-HG171-II/III-01
- Status last verified
- Dec 2022
- First submitted
- 16 Dec 2022
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu H, Zhang G, Mao J, Chen X, Zhan Y, Lin L, Zhang T, Tang Y, Lin F, Zhu F, Lin Y, Zeng Y, Zhang K, Yuan W, Liang Z, Sun R, Huo L, Hu P, Lin Y, Zhuang X, Wei Z, Chen X, Yan W, Yan X, Mu L, Lin Z, Tu X, Tan H, Huang F, Hu Z, Li H, Li G, Fu H, Yang Z, Chen X, Wang FS, Zhong N. 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. EClinicalMedicine. 2024 Apr 10;71:102582. doi: 10.1016/j.eclinm.2024.102582. eCollection 2024 May.
PubMed 38618202
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of GST-HG171/Ritonavir in Patients With Mild to Moderate COVID-19
- ClinicalTrials.gov ID
- NCT05656443
- Acronym / sponsor ID
- GST-HG171-II/III-01
- Conditions
- COVID-19 Pneumonia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,246 participants (actual)
- Lead sponsor
- Fujian Akeylink Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GST-HG171/Ritonavir | Experimental | Drug: GST-HG171/Ritonavir |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects aged ≥ 18 years when signing the informed consent form (ICF);
- Subjects with reverse transcription-polymerase chain reaction (RT-PCR) test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in specimens such as nasopharyngeal swabs/oropharyngeal swabs for the first time within 4 days prior to randomization who meet the diagnostic and treatment criteria for mild and moderate cases in the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9) issued by the National Health Commission of the Peoples Republic of China ;
- RT-PCR result of N gene or ORF gene of SARS-CoV-2 within 48 hours before randomization shows a Ct value < 35; at least 2 COVID-19 target symptoms appeared for the first time within 72 hours before randomization (COVID-19 target symptoms include fever, cough, stuffy or runny nose, sore throat or dry throat, shortness of breath or difficulty breathing, headache, muscle or body aches, diarrhoea, chills, nausea, and vomit), including at least one designated symptom: fever, cough, stuffy or runny nose, sore throat or dry throat, shortness of breath or difficulty breathing;
- Women of childbearing potential must have a negative serum pregnancy test during the screening period. Subjects should take effective contraceptive measures throughout the study period since signing the informed consent form and for 28 days after the end of the study;
- Subjects who are able to understand the study procedures and methods, and voluntarily participate in the study and sign the ICF after being fully informed.
Key exclusion criteria (17 listed)
- Subjects who are known to have hypersensitivity to any component of the investigational drug;
- Subjects who meet diagnostic and treatment criteria for severe and critical cases in the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 10) issued by National Health Commission of the People's Republic of China;
- Abnormal hepatic function at screening: total bilirubin ≥ 1.5 × upper limit of normal (ULN); ALT or AST ≥ 3 × ULN;
- Human immunodeficiency virus (HIV) antibody positive, treponema pallidum-specific antibody (TP-PA) positive or rapid plasma reagin (RPR) positive for syphilis at screening;
- Abnormal renal function at screening: serum creatinine ≥ 1.5 × ULN;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GST-HG171/Ritonavirdose of 150 mg GST-HG171 with 100 mg ritonavir | Drug | GST-HG171/Ritonavir |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Time to sustained clinical recovery of 11 COVID-19 symptoms
Time frame: Day 1 through Day 28
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for two consecutive days
5 secondary outcomes
Viral load
Time frame: Baseline through Day 5
Time to sustained clinical recovery of 5 COVID-19 symptoms
Time frame: Day 1 through Day 28
Time to sustained alleviation of 11 COVID-19 symptoms
Time frame: Baseline through Day 28
Proportion of participants in clinical recovery
Time frame: Day 1 through Day 28
AE
Time frame: Day 1 through Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Derived from this study: PubMed 38618202Lu H, Zhang G, Mao J, Chen X, Zhan Y, Lin L, Zhang T, Tang Y, Lin F, Zhu F, Lin Y, Zeng Y, Zhang K, Yuan W, Liang Z, Sun R, Huo L, Hu P, Lin Y, Zhuang X, Wei Z, Chen X, Yan W, Yan X, Mu L, Lin Z, Tu X, Tan H, Huang F, Hu Z, Li H, Li G, Fu H, Yang Z, Chen X, Wang FS, Zhong N. 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. EClinicalMedicine. 2024 Apr 10;71:102582. doi: 10.1016/j.eclinm.2024.102582. eCollection 2024 May.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GST-HG171/Ritonavir in people with COVID-19 Pneumonia, run by Fujian Akeylink Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to sustained clinical recovery of 11 COVID-19 symptoms (time frame: Day 1 through Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05656443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.