Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT05659602
Status:
COMPLETED
Last Update Posted:
2024-10-10
First Post:
2022-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in COVID-19 Patients
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2022-12-20', 'studyFirstSubmitQcDate': '2022-12-20', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion of the participants who have progression of COVID-19.', 'timeFrame': 'Up to 12 days', 'description': 'Proportion of participants who progress to moderate/severe/critical type of COVID-19 illness.'}], 'primaryOutcomes': [{'measure': 'Time to achieving SARS-CoV-2 clearance (defined as negative quantitative Real-Time polymerase chain reaction [qRT-PCR] tests taken on two consecutive days).', 'timeFrame': 'Up to 12 days', 'description': 'Median time from first dose to achieving SARS-COV-2 clearance.'}, {'measure': 'Proportion of participants with SARS-CoV-2 clearance.', 'timeFrame': 'Up to 12 days', 'description': 'Proportion of participants achieving SARS-CoV-2 clearance from the first dose until Day 12.'}], 'secondaryOutcomes': [{'measure': 'Clinical recovery of COVID-19.', 'timeFrame': 'Up to 12 days', 'description': 'Time to sustained COVID-19 symptoms recovery; Time to COVID-19 symptoms improvement; Proportion of participants with sustained COVID-19 symptoms recovery; Proportion of participants with COVID-19 symptoms improvement.'}, {'measure': 'Viral load.', 'timeFrame': 'Up to 12 days', 'description': 'Change of CT values of N gene and ORF1 gene (qRT-PCR) from baseline.'}, {'measure': 'Adverse event.', 'timeFrame': 'Up to 12 days', 'description': 'Incidence and severity of adverse events.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Treatment'], 'conditions': ['Coronavirus Disease 2019(COVID-19)']}, 'descriptionModule': {'briefSummary': 'To evaluate the preliminary efficacy and safety of HH-120 nasal spray in the treatment of asymptomatic or mild COVID-19.', 'detailedDescription': 'During this study, participants will receive HH-120 nasal spray treatment for 6 consecutive days, the efficacy and safety of HH-120 will be assessed throughout the study period based on viral clearance, clinical recovery, illness severity and adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 65 years old.\n* Participants with mild COVID-19 with symptom onset≤5 days or asymptomatic COVID-19.\n* Participants being able and willing to provide informed consent prior to any study-specific procedure.\n\nExclusion Criteria:\n\n* Participants with moderate or severe COVID-19.\n* Participants within the pregnancy or breastfeeding period or plan to be pregnant during the study period.\n* Participants requiring oxygen treatment (such as non-invasive ventilation, invasive mechanical ventilation, ECMO, etc.).\n* Participants with nasal disease that is inconvenient or intolerant of nasal spray administration, or cannot use the nasal spray treatment.\n* Participants with comorbid Malignancy or with a history of malignancy.\n* Participants with active or uncontrolled systemic autoimmune disease.\n* Insufficient function of key organs.\n* Other reasons considered by the investigator to be unsuitable for the trial.'}, 'identificationModule': {'nctId': 'NCT05659602', 'briefTitle': 'A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Ditan Hospital'}, 'officialTitle': 'A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in Participants Diagnosed With Asymptomatic or Mild COVID-19', 'orgStudyIdInfo': {'id': 'HH120-IIT-NS05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HH-120 group', 'description': 'HH-120 Nasal Spray', 'interventionNames': ['Biological: HH-120 Nasal Spray']}], 'interventions': [{'name': 'HH-120 Nasal Spray', 'type': 'BIOLOGICAL', 'description': 'HH-120 Nasal Spray 8-10 times per day for 6 consecutive days', 'armGroupLabels': ['HH-120 group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Ditan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Ronghua Jin', 'investigatorAffiliation': 'Beijing Ditan Hospital'}}}}