A cluster randomized trial of interferon ß-1a for the reduction of transmission of SARS-Cov-2: protocol for the Containing Coronavirus Disease 19 trial (ConCorD-19).

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  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 100968551 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2334 (Electronic) Linking ISSN: 14712334 NLM ISO Abbreviation: BMC Infect Dis Subsets: MEDLINE
    • Publication Information:
      Original Publication: London : BioMed Central, [2001-
    • Subject Terms:
      Randomized Controlled Trials as Topic* ; COVID-19 Drug Treatment*; Antiviral Agents/*therapeutic use ; Interferon-beta/*therapeutic use; COVID-19/diagnosis ; COVID-19/transmission ; COVID-19 Testing ; Humans ; SARS-CoV-2 ; Treatment Outcome
    • Abstract:
      Background: SARS-CoV-2 infection rapidly spreads in populations due to the high rates of community transmission. Interrupting the shedding of SARS-CoV-2 may reduce the incidence of Coronavirus Disease 19 (COVID-19). Herein we provide a protocol for a cluster randomized trial that will examine the effectiveness of treatment with interferon (IFN) ß-1a compared to standard of care in limiting the transmission of SARS-CoV-2. Co-primary objectives are to determine whether IFN therapy reduces (a) the proportion of infected cases shedding SARS-CoV-2 at day 11 post randomization and (b) the incidence of transmission of SARS-CoV-2 infection from index cases to treatment-eligible household post-exposure contacts at day 11 after randomization. Secondary objectives include assessing the impact of IFN treatment on duration of viral clearance, hospitalizations and fatalities, and evaluating the safety of IFN treatment.
      Methods: Three hundred and ten households, each including an index case with a recent COVID-19 diagnosis and at least one asymptomatic treatment-eligible household contact, will be randomized to receive 3 doses of 125 μg IFN ß-1a by subcutaneous administration (days 1, 6, and 11), or standard of care. All participants will be followed until day 29.
      Discussion: The results from this trial will identify whether IFN ß treatment of mild or moderate COVID-19 cases accelerates viral clearance and prevents disease progression and whether IFN ß treatment of post-exposure contacts of COVID-19 cases reduces transmission of infection.
      Trial Registration: This trial is registered at ClinicalTrials.gov NCT04552379; date of registration September 17, 2020.
      (© 2021. The Author(s).)
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    • Contributed Indexing:
      Keywords: COVID; COVID-19; Coronavirus; Interferon; Prevention; Protocol; Transmission
    • Molecular Sequence:
      ClinicalTrials.gov NCT04552379
    • Accession Number:
      0 (Antiviral Agents)
      77238-31-4 (Interferon-beta)
    • Publication Date:
      Date Created: 20210814 Date Completed: 20210831 Latest Revision: 20221207
    • Publication Date:
      20240105
    • Accession Number:
      PMC8361407
    • Accession Number:
      10.1186/s12879-021-06519-4
    • Accession Number:
      34388972