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

Chaccour 2021.

Study characteristics
Methods
  • Trial design: double‐blind RCT with 2 parallel arms

  • Type of publication: journal publication

  • Setting: outpatient

  • Recruitment dates: July to September 2020

  • Country: Spain

  • Language: English

  • Number of centres: 1

  • Study purpose (treatment, prevention): treatment

  • Trial registration number: NCT04390022

  • Date of registration: 15 May 2020

Participants
  • Number of participants (randomized/analyzed): 24/24

  • Age (median): overall 28 years

  • Males, n: overall 12 (50%)

  • Severity of condition according to study definition: outpatients with non‐severe symptoms

  • Severity of condition according to WHO scale: 2 to 3

  • Co‐morbidities: existing co‐morbidity was specified as exclusion criterion.

  • Virus detection performed at baseline (test‐positive at baseline): RT‐PCR (100%)

  • Inclusion criteria: consecutive outpatients attending the emergency department of the Clinica Universidad de Navarra (Pamplona, Spain) with symptoms compatible with COVID‐19; no more than 72 hours of fever or cough; positive PCR for SARS‐CoV‐2

  • Exclusion criteria: positive IgG against SARS‐CoV‐2; co‐morbidities considered risk factors for severe disease or COVID‐19 pneumonia at baseline

Interventions
  • Details of intervention

    • Type and dose: ivermectin 0.4 mg/kg, single dose

    • Route of administration: oral

  • Treatment details of control group

    • Placebo

  • Concomitant therapy: NA

  • Duration of follow‐up: 28 days

  • Treatment cross‐overs: none

Outcomes
  • Primary study outcome

    • Proportion of patients with a positive SARS‐CoV‐2 PCR

  • Relevant review outcomes reported

    • Mortality at 28 days

    • Viral clearance (RT‐PCR, E‐gene) at 7 days

    • Adverse events within 28 days

    • Serious adverse events within 28 days

  • Additional study outcomes reported

    • Viral load evolution within 21 days

    • Viral clearance (RT‐PCR, N‐gene) at 7 days

    • Patient‐days of any symptoms, cough, and ansomia

    • IgG‐titres at 21 days

Notes
  • Date of publication: 23 February 2021

  • Sponsor/funding: departmental resources

  • Additional results posted in registry

  • Information on ethics votum: name of responsible ethics committee, reference number of proposal, and votum provided by author via personal correspondence