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

Table 1 The schedule of enrolment, interventions and assessments

Timepoint	Study period
	Enrolment	Allocation	Post-allocation			Close-out
	-t₁	0	T_{1 (7 days)}	T_{2 (14 days)}	T*_{3 (21 days)}	T_{x (21 days)}
Enrolment	x
Eligibility screen	x
Informed consent	x
SARS-CoV-2 RNA testing ^{household members}		x
Allocation		x
Interventions
Experimental arm			x	x
Control arm			x	x
Assessments
Sociodemographic characteristics of participants/households; dwelling type and size; household structure; comorbidities; smoking history [16]	x
Household, occupational and community-related exposures; and utilisation of individual prevention measures [16]	x		x	x	x
Pharmacovigilance measures			x	x	x
Outcome variables
SARS-CoV-2 infection				x^#
Severity of COVID-19 infection ^¤			x	x	x
Other variables
Adherence (spray use)			x	x	x

*Index cases and infected household members only; ^#or at the time of symptom development; measured by the time taken for all symptoms to resolve (days), and the number of hospital admissions per group

ISSN: 1745-6215