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

Fujian Akeylink Biotechnology Co., Ltd.1 site in 1 country1,246 target enrollmentDecember 19, 2022

ConditionsCOVID-19 Pneumonia

InterventionsGST-HG171/Ritonavir Placebo

DrugsGST-HG171/Ritonavir Placebo

Overview

Phase: Phase 2
Intervention: GST-HG171/Ritonavir
Conditions: COVID-19 Pneumonia
Sponsor: Fujian Akeylink Biotechnology Co., Ltd.
Enrollment: 1246
Locations: 1
Primary Endpoint: Time to sustained clinical recovery of 11 COVID-19 symptoms
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 19, 2022

End Date

July 14, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fujian Akeylink Biotechnology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.
•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;

Arms & Interventions

GST-HG171/Ritonavir

Intervention: GST-HG171/Ritonavir

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Secondary Outcomes

Viral load(Baseline through Day 5)
Time to sustained clinical recovery of 5 COVID-19 symptoms(Day 1 through Day 28)
AE(Day 1 through Day 28)
Time to sustained alleviation of 11 COVID-19 symptoms(Baseline through Day 28)
Proportion of participants in clinical recovery(Day 1 through Day 28)