Skip to main content
. 2021 Jul 28;2021(7):CD015017. doi: 10.1002/14651858.CD015017.pub2

Shah Bukhari 2021.

Study characteristics
Methods
  • Trial design: open‐label RCT with 2 parallel arms

  • Type of publication: preprint

  • Setting: inpatient

  • Recruitment dates: March to June 2020

  • Country: Pakistan

  • Language: English

  • Number of centres: 1

  • Study purpose (treatment, prevention): treatment

  • Trial registration number: NCT04392713

  • Date of registration: 19 May 2020

Participants
  • Number of participants (randomized/analyzed): 100/86

  • Age (mean): overall 41 (SD NR) years

  • Males, n: overall 73 (85%)

  • Severity of condition according to study definition: hospitalized, mild‐to‐moderate symptoms

  • Severity of condition according to WHO scale: 4 to 5

  • Co‐morbidities: diabetes, hypertension

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

  • Inclusion criteria: provision of signed and dated informed consent form; stated willingness to comply with all study procedures and admission for the duration of the study; male or female; aged 15–65 years; in good general health with no or mild‐to‐moderate symptoms of COVID‐19; PCR positive for SARS‐CoV‐2; ability to take oral medication

  • Exclusion criteria: SARS‐CoV‐2 infection with severe symptoms, likely due to cytokine release syndrome; uncontrolled co‐morbidities, and immunocompromised states; history of ivermectin allergy; receiving CYP 3A4‐inhibitors or ‐inducers

Interventions
  • Details of intervention

    • Type and dose: ivermectin 12 mg, single dose

    • Route of administration: oral

  • Treatment details of control group

    • No treatment except standard of care

  • Concomitant therapy: standard of care including vitamin C, vitamin D3, paracetamol administered in both study arms; unclear whether standard of care included chloroquine as stated in the protocol

  • Duration of follow‐up: 28 days

  • Treatment cross‐overs: none

Outcomes
  • Primary study outcome

    • Days to achieve RT‐PCR negativity

  • Relevant review outcomes reported

    • Viral clearance (RT‐PCR) at 3, 7, and 14 days

    • Adverse events within 28 days

  • Additional study outcomes reported

    • None

Notes
  • Date of publication: 5 February 2021

  • Sponsor/funding: departmental resources

  • Correspondence with the author team: author request sent (publication status, outcome data including number of participants and events for participants with negative RT‐PCR at 7 and 14 days); no response received from the author

  • Information on ethics votum: name of responsible ethics committee, reference number of proposal, and votum reported