Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in Participants Diagnosed With Asymptomatic or Mild COVID-19

ID
Name
HH120-IIT-NS05
Description
To evaluate the preliminary efficacy and safety of HH-120 nasal spray in the treatment of asymptomatic or mild COVID-19.
Trial arms
Trial start
2022-07-09
Estimated PCD
2023-01-03
Trial end
2023-01-03
Status
Completed
Treatment
HH-120 Nasal Spray
HH-120 Nasal Spray 8-10 times per day for 6 consecutive days
Arms:
HH-120 group
Size
111
Primary endpoint
Time to achieving SARS-CoV-2 clearance (defined as negative quantitative Real-Time polymerase chain reaction [qRT-PCR] tests taken on two consecutive days).
Up to 12 days
Proportion of participants with SARS-CoV-2 clearance.
Up to 12 days
Eligibility criteria
Inclusion Criteria: * 18 to 65 years old. * Participants with mild COVID-19 with symptom onset≤5 days or asymptomatic COVID-19. * Participants being able and willing to provide informed consent prior to any study-specific procedure. Exclusion Criteria: * Participants with moderate or severe COVID-19. * Participants within the pregnancy or breastfeeding period or plan to be pregnant during the study period. * Participants requiring oxygen treatment (such as non-invasive ventilation, invasive mechanical ventilation, ECMO, etc.). * Participants with nasal disease that is inconvenient or intolerant of nasal spray administration, or cannot use the nasal spray treatment. * Participants with comorbid Malignancy or with a history of malignancy. * Participants with active or uncontrolled systemic autoimmune disease. * Insufficient function of key organs. * Other reasons considered by the investigator to be unsuitable for the trial.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 111, 'type': 'ACTUAL'}}
Updated at
2023-09-28

1 organization

1 product

1 indication

Organization
Beijing Ditan Hospital
Product
HH-120
Indication
COVID-19