SPL7013 Nasal Spray safety and performance in patients with COVID-19
- Conditions
- Reduced viral burden and prevention of disease progression in non-hospitalised patients with COVID-19 (SARS-CoV-2 infection)Infections and Infestations
- Registration Number
- ISRCTN70449927
- Lead Sponsor
- Starpharma (Australia)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 231
1. Females and males aged 16 years and older
2. Positive PCR test for COVID-19 within 2 days (if possible 24 hours) of enrolment
3. Score of 1 to 3 on the WHO Clinical Progression Scale (CPS)
4. Able to understand and willing to comply with the investigation plan procedures and restrictions
1. Allergy to any ingredient in the device formulation (SPL7013, parabens, Carbopol 974P, glycerine, propylene glycol, or EDTA)
2. Treated or about to be treated with medications administered by inhalation (with exception of asthma-related treatment) or via the nasal route
3. Pregnant, planning to become pregnant, or breastfeeding, or within 3 months of last pregnancy outcome
4. In the opinion of the investigator, should not participate in the investigation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method