BioBlock nasal spray against COVID-19

Phase 2

Completed

• Conditions: Prevention of COVID-19 (SARS-CoV-2 infection) among in household contacts of SARS-CoV-2 positive individuals; Infections and Infestations; COVID-19 (SARS-CoV-2 infection)

• Registration Number: ISRCTN48554326
• Lead Sponsor: niversity of Tartu

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35101094/ (added 02/02/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-14
• Study Completion: 2021-12-30
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

Index case:
1.Confirmed case of COVID-19 infection with at least one SARS-CoV-2 PCR negative person household contact
2. Aged =16 years

Household contacts:
1. SARS-CoV-2 PCR negative household contact of the index case
2. Aged =16 years

Exclusion Criteria

Current exclusion criteria as of 27/08/2021:
1. Aged <16 years
2. Pregnancy
3. Use of active cancer treatment
4. Use of biological treatment
5. Previously confirmed COVID-19
6. Any organ transplantation
7. Single person household
8. Requires hospitalisation prior to study start
9. Required to take regular medications administered by inhalation, or via the naso- and oropharyngeal route
10. Asthma
11. Known allergies to BioBlock components

Previous exclusion criteria:
1. Aged <16 years
2. Pregnancy
3. Use of active cancer treatment
4. Use of biological treatment
5. Previously vaccinated against COVID-19
6. Previously confirmed COVID-19
7. Any organ transplantation
8. Single person household
9. Requires hospitalisation prior to study start
10. Required to take regular medications administered by inhalation, or via the naso- and oropharyngeal route
11. Asthma
12. Known allergies to BioBlock components

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of COVID-19 infection in household members measured using PCR swab taken at 1 and 14 days

Secondary Outcome Measures

Name	Time	Method
Severity of COVID-19 infection measured using the time taken for all symptoms to resolve (days) from participant questionnaires at 1, 7, 14, 21 days for index cases and 1, 7, 14 days for SARS-CoV-2 PCR negative household contacts