Study of GST-HG171/Ritonavir Compared With Placebo in Patients With Mild to Moderate COVID-19
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GST-HG171/Ritonavir
|
Drug: GST-HG171/Ritonavir
dose of 150 mg GST-HG171 with 100 mg ritonavir
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Time to sustained clinical recovery of 11 COVID-19 symptoms [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 Outcome Measures
- Viral load [Baseline through Day 5]
Change of viral load compared to the baseline
- Time to sustained clinical recovery of 5 COVID-19 symptoms [Day 1 through Day 28]
The time from the start of treatment to the time when respiratory and feverish symptoms get scores of 0 for two consecutive days
- Time to sustained alleviation of 11 COVID-19 symptoms [Baseline through Day 28]
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
- Proportion of participants in clinical recovery [Day 1 through Day 28]
Proportion of participants in clinical recovery
- AE [Day 1 through Day 28]
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants ≥18 years of age.
-
Confirmed SARS-CoV-2 infection 4 days prior to randomization.
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The subjects were classified as mild/moderate type COVID-19.
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Initial onset 2 of 11 COVID-19 symptoms within 48 hours before randomization,respiratory and feverish symptoms must be included.
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Participants who are willing and able to comply with the protocol for treatment plan, virological testing, laboratory testing and other study procedures.
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Fertile participants must agree to take effective contraceptive measures.
Exclusion Criteria:
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Has hypersensitivity or other contraindication to any of the components of the study interventions.
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Patients with severe or critical COVID-19.
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Active liver disease, or obvious abnormal liver function (ALT or AST ≥ 3ULN, or total bilirubin ≥ 1.5ULN).
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Receiving dialysis or have known moderate to severe renal impairment.
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Compromised immune system.
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Acute episode of chronic respiratory diseases, including bronchial asthma, chronic obstructive pulmonary disease.
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Suspected or confirmed concurrent active systemic infection other than COVID-19.
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Any comorbidity requiring surgery within 14 days prior to study entry, or that is considered life-threatening within 30 days prior to study entry, as determined by the investigator.
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Treatment with antivirals against SARS-CoV-2 within 14 days prior to randomization.
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Current or expected use of strong CYP3A4 inducers, inhibitors or medications that are highly dependent on CYP3A4 for clearance.
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Has received or is expected to receive COVID-19 monoclonal antibody or convalescent COVID-19 plasma during study treatment.
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Has received any SARS-CoV-2 vaccine within 3 months prior to randomization.
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Participating in another interventional clinical study with an investigational compound or device.
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Pregnant, lactating women or those with a positive pregnancy test.
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Previous administration with any investigational drug within 3 months before the study drug administration.
-
Participants who are judged by the investigator to be unsuitable to participate in this study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fujian Akeylink Biotechnology Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GST-HG171-II/III-01