Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-27 @ 7:23 PM
Study NCT ID:
NCT05689203
Status:
UNKNOWN
Last Update Posted:
2023-01-19
First Post:
2023-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-15', 'studyFirstSubmitDate': '2023-01-15', 'studyFirstSubmitQcDate': '2023-01-15', 'lastUpdatePostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to sustained recovery of COVID-19 symptoms', 'timeFrame': 'Baseline through Day 29', 'description': 'The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for three consecutive days'}], 'secondaryOutcomes': [{'measure': 'Time to sustained alleviation of COVID-19 symptoms', 'timeFrame': 'Baseline through Day 29', 'description': 'The time from the start of treatment to the time when the severity of 11 COVID-19 symptoms downgrade for three consecutive days'}, {'measure': 'Time to sustained recovery/ alleviation of each COVID-19 symptoms', 'timeFrame': 'Baseline through Day 29', 'description': 'The time from the start of treatment to the time when each COVID-19 symptoms get scores of 0 for three consecutive days,or the severity of each COVID-19 symptoms downgrade for three consecutive days'}, {'measure': 'Time to sustained recovery/ alleviation/exacerbation of first COVID-19 symptoms', 'timeFrame': 'Baseline through Day 29', 'description': 'The time from the start of treatment to the time when first COVID-19 symptoms get scores of 0 for three consecutive days,or the severity of first COVID-19 symptoms downgrade for three consecutive days,or the severity of first COVID-19 symptoms deteriorate for two consecutive days'}, {'measure': 'Viral load', 'timeFrame': 'Baseline through Day 15', 'description': 'Changes of viral load compared to the baseline'}, {'measure': 'The time when the virus first turn negative and the proportion of patients that the virus turn negative', 'timeFrame': 'Baseline through Day 15', 'description': 'The time when the virus first turn negative and the proportion of patients that the virus turn negative'}, {'measure': 'All-cause mortality, COVID-19 related mortality', 'timeFrame': 'Baseline through Day 29', 'description': 'All-cause mortality, COVID-19 related mortality'}, {'measure': 'The Adverse events', 'timeFrame': 'Baseline through Day 29', 'description': 'TEAEs associated with drug,SAE associated with drug, adverse events leading to withdrawal, vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, etc'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'A Phase 2 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects between ages of 18-80 years.\n2. Confirmed SARS-CoV-2 infection as determined by RT-PCR or antigen test in any specimen collected within 48 hours prior to randomization，first diagnosis of this infection within 72 hours prior to the randomization.\n3. Initial onset of the COVID-19-related symptoms/signs within 48 hours prior to the randomization，and at least 1 of the COVID-19-related symptoms/signs (Cough,Shortness of breath or difficulty breathing,fever,Chills,Body pain or muscle pain,Diarrhea,Nausea,Vomiting，Headache，Sore throat，Stuffy or runny nose)present on the day of randomization.\n\nExclusion Criteria:\n\n1. Previous treatment with QLS1128 sustained-release tablets or other 3CL protease inhibitors failed.\n2. Has received local approved anti-SARS-CoV-2 drugs within 7 days before screening or plan to receive them during the study period (e.g. paxlovid, azvudine, etc.)\n3. Has received monoclonal antibody against SARS-CoV-2 virus within 1 year prior to screening.\n4. Has received or expect to receive convalescent plasma therapy for COVID-19 patients during the trial.\n5. Has received any CYP3A4/2C8 strong inducer within 28 days prior to screening or plan to receive any CYP3A4/2C8 strong inducer during the study period.\n6. A known history of active liver disease , including acute/chronic hepatitis B, hepatitis C, cirrhosis, or acute liver failure.\n7. Allergic or have contraindications to test drugs or test drug excipients.'}, 'identificationModule': {'nctId': 'NCT05689203', 'briefTitle': 'A Phase 2 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19', 'orgStudyIdInfo': {'id': 'QLS1128-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLS1128', 'description': 'QLS1128 will be administered orally for 5 days.', 'interventionNames': ['Drug: QLS1128']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo matching to QLS1128 will be administered orally for 5 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'QLS1128', 'type': 'DRUG', 'description': 'dose 1', 'armGroupLabels': ['QLS1128']}, {'name': 'QLS1128', 'type': 'DRUG', 'description': 'dose 2', 'armGroupLabels': ['QLS1128']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yunfei ju, M.D.', 'role': 'CONTACT', 'email': 'yunfei.ju@qilu-pharma.com', 'phone': '15053185458'}], 'facility': 'Qilu Pharmaceutical Co., Ltd.', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'yunfei ju, M.D.', 'role': 'CONTACT', 'email': 'yunfei.ju@qilu-pharma.com', 'phone': '15053185458'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}