SPL7013 Nasal Spray safety and performance in patients with COVID-19

A randomized, double-blind, placebo-controlled investigation to evaluate the performance and safety of SPL7013 Nasal Spray in non-hospitalised patients with COVID-19

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN70449927

Enrollment

160

Registered

2022-12-01

Start date

2022-12-05

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reduced viral burden and prevention of disease progression in non-hospitalised patients with COVID-19 (SARS-CoV-2 infection) Infections and Infestations

Interventions

Randomisation will be performed using a site-specific, computer-generated randomisation list that is based upon a permutation block procedure. The randomisation list will link the treatment group with

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Area under the curve (AUC) of nasal swab SARS-CoV-2 viral load measured using reverse transcription quantitative real-time polymerase chain reaction (RT-qPCR) through Day 7	—

Secondary

Measure	Time frame
1. Peak nasal swab SARS-CoV-2 viral load measured using RT-qPCR on Days 1-8 2. Mean change in nasal swab SARS-CoV-2 viral titre, measured using RT-qPCR, at each viral load determination (Day 2-8) from baseline viral load at screening (i.e., prior to randomisation) 3. Time to negative SARS-CoV-2 RT-qPCR (to Day 8) 4. Number of days between the start and complete resolution of acute COVID-19-related symptoms measured using the FLU-PRO Plus questionnaire to Day 8 5. Disease progression to a score of 4 or more measured on the World Health Organization Clinical Progression Scale (WHO CPS) by Day 7 6. Frequency and severity of adverse events (AEs) as measured by participant report and investigator detection (Day 1-8)	—

Measure

Time frame

1. Peak nasal swab SARS-CoV-2 viral load measured using RT-qPCR on Days 1-8 2. Mean change in nasal swab SARS-CoV-2 viral titre, measured using RT-qPCR, at each viral load determination (Day 2-8) from baseline viral load at screening (i.e., prior to randomisation) 3. Time to negative SARS-CoV-2 RT-qPCR (to Day 8) 4. Number of days between the start and complete resolution of acute COVID-19-related symptoms measured using the FLU-PRO Plus questionnaire to Day 8 5. Disease progression to a score of 4 or more measured on the World Health Organization Clinical Progression Scale (WHO CPS) by Day 7 6. Frequency and severity of adverse events (AEs) as measured by participant report and investigator detection (Day 1-8)

—

Countries

England, Pakistan, United Kingdom

Contacts

Public ContactJeremy Paull

jeremy.paull@starpharma.com+61 (0)385322736

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026