BioBlock nasal spray against COVID-19

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN48554326

Enrollment

342

Registered

2021-06-14

Start date

2021-05-12

Completion date

Unknown

Last updated

2022-02-21

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

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)

Interventions

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, inves

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Estonia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026