BioBlock nasal spray against COVID-19

• Register: ISRCTN
• Last refreshed on: 21 February 2022
• Main ID: ISRCTN48554326
• Date of registration: 14/06/2021
• Prospective Registration: No
• Primary sponsor: University of Tartu
• Public title: BioBlock nasal spray against COVID-19
• Scientific title: Cluster randomized, controlled, triple-blind trial assessing the efficacy of intranasally administered virus-neutralizing bovine colostrum supplement in preventing SARS-CoV-2 infection in household contacts of SARS-CoV-2 positive individuals
• Date of first enrolment: 12/05/2021
• Target sample size: 342
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN48554326
• Study type: Interventional
• Study design: Cluster randomized triple-blinded controlled trial (Prevention)
• Phase: Phase II

Countries of recruitment

Estonia

Contacts

• Name: Anneli Uusküla

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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)

Intervention(s)

This is a cluster randomized placebo-controlled trial of household contacts of laboratory-confirmed cases of COVID-19 compared to an uninfected control group of household contacts. Participants, investigators, and outcome assessors will be blind to allocation. The placebo and BioBlock sprays will be blinded at the site of manufacture.

At a minimum, enrolled household cases and contacts will complete data and specimen collection at enrollment (Day 1) and for 14 days of follow-up, with at least two follow-up visits interviews for household contacts and three follow-up visits for index cases. Household (index case and household contacts) respiratory samples will be collected for SARS-CoV-2 RNA testing at 1 and 14 days. Questionnaires will be completed by Index cases at 1, 7, 14, and 21 days and by SARS-CoV-2 PCR negative household contacts at 1, 7, 14 days.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

Protocol v1

Nil known

Source(s) of Monetary Support

CHEMI-PHARM AS

Ethics review

Status:
Approval date:
Contact:

Approved 26/04/2021, Research Ethics Committee of the University of Tartu (University of Tartu, Raekoja plats 9, 51004 Tartu, Estonia; [phone]; [e-mail]), ref: 339/T-1

Results

• Date Completed: 30/12/2021