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. 2021 Jul 28;2021(7):CD015017. doi: 10.1002/14651858.CD015017.pub2

NCT04891250.

Methods
  • Trial design: double‐blind RCT with 3 parallel arms

  • Type of record: trial register entry

  • Sample size: 800

  • Setting: NR

  • Country: Zambia

  • Language: English

  • Number of centres: 1

  • Study purpose (treatment, prevention): treatment and prevention

  • Trial registration number: NCT04891250

  • Date of registration: 18 May 2021

Participants
  • Inclusion criteria

    • People diagnosed positive for SARS‐CoV‐2 by rRT‐PCR with presence of a fever, cough, sore throat, or a combination

  • Exclusion criteria

    • Allergic to ivermectin or potential for a drug–drug interaction with ivermectin

    • Chronic illnesses (e.g. ischaemic heart disease, heart failure, documented cardiomyopathy, chronic kidney disease, chronic liver disease)

    • Having received ivermectin in the last 7 days

    • Pregnant or lactating women

    • Participation in any other clinical trial within the last 1 month

Interventions
  • Details of intervention

    • Type and dose: ivermectin, no details on dosing or frequency scheme

    • Route of administration: NR

  • Treatment details of control group

    • No treatment except standard of care

  • Concomitant therapy: unclear

Outcomes
  • Primary study outcome

    • All‐cause COVID‐19 related mortality at 28 days

    • COVID‐19 infection within study duration

  • Relevant review outcomes planned

    • All‐cause COVID‐19‐related mortality at 28 days

    • COVID‐19 infection within study duration

  • Additional study outcomes

    • Patient cure rate at 14–28 days

    • Determine proportion who will develop severe disease and needing admission in addition to the above outcomes within 90 days

Notes
  • Reason for awaiting classification: unclear description regarding intervention details, standard of care, inclusion criteria for prophylaxis substudy

  • Recruitment status: not yet recruiting

  • Prospective completion date: December 2022

  • Date last update posted: 18 May 2021

  • Sponsor/funding: Centre for Infectious Disease Research in Zambia, Ministry of Health and University of Zambia