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Clinical Trials/ISRCTN48554326
ISRCTN48554326
Completed
Phase 2

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

niversity of Tartu0 sites342 target enrollmentJune 14, 2021

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of Tartu
Enrollment
342
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

Registry
who.int
Start Date
June 14, 2021
End Date
December 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Tartu

Eligibility 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

Outcomes

Primary Outcomes

Not specified

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