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. 2022 Jan 31;23(1):92.
doi: 10.1186/s13063-022-06039-9.

Cluster randomised, controlled, triple-blind trial assessing the efficacy of intranasally administered virus-neutralising bovine colostrum supplement in preventing SARS-CoV-2 infection in household contacts of SARS-CoV-2-positive individuals: a study protocol

Anneli Uusküla  1 , Aime Keis  2 , Karolin Toompere  2 , Anu Planken  3   4 , Konstantin Rebrov  5
Affiliations

Cluster randomised, controlled, triple-blind trial assessing the efficacy of intranasally administered virus-neutralising bovine colostrum supplement in preventing SARS-CoV-2 infection in household contacts of SARS-CoV-2-positive individuals: a study protocol

Anneli Uusküla et al. Trials. .

Abstract

The SARS-CoV-2 enters into the human body mainly through the nasal epithelial cells. Prevention of SARS-CoV-2 infection at the point of nasal entry is a novel strategy that has the potential to help contain the ongoing pandemic. BioBlock is a nasal spray of anti-SARS-CoV-2 preparation based on virus-neutralising antibodies prepared from colostrum from cows immunised with SARS-CoV-2 spike protein. This triple-blind placebo-controlled cluster randomised parallel trial seeks to evaluate the efficacy of a BioBlock spray in the prevention and treatment of SARS-CoV-2 infection. Laboratory-confirmed COVID-19 cases and their household members will be randomly allocated to each of either the intervention (BioBlock nasal spray) or the placebo (nasal spray) arms. The intervention is a 14-day course of nasal spray used by index case and household contacts. In most countries, those with confirmed or suspected infections are requisitioned to isolate at home, putting other members of their household at risk of infection. Therefore, in parallel to the need of household transmission prevention measures, households also present as a good model for infection transmission studies, allowing for the testing of several close contact transmission prevention study hypotheses. Our hope is that if the trial results are encouraging, this will provide new and additional COVID-19 prevention strategies. TRIAL REGISTRATION: ISRCTN48554326 Registered on June 14, 2021.

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Conflict of interest statement

Konstantin Rebrov holds a position of Business Development Manager at the ChemiPharm.

Figures

Fig. 1
Fig. 1
Household-based infection control trials — possible options for using the test device and hypotheses tested. Intervention A, testing the effect on infectiousness: In close contacts of the SARS-CoV-2 carrier, using a study device by the SARS-CoV-2 carrier (only) would be associated with a lower SARS-CoV-2 infection rate among close contacts. Intervention B, testing the effect on susceptibility: In close contacts of the SARS-CoV-2 carrier, using a study device would be associated with a lower SARS-CoV-2 infection rate. Intervention C: In close contacts of the SARS-CoV-2 carrier, using a study device by the close contacts and SARS-CoV-2 carrier would be associated with a lower SARS-CoV-2 infection rate
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