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

Ahmed 2020.

Study characteristics
Methods
  • Trial design: double‐blind RCT with 3 parallel arms, only 2 arms relevant; the third arm investigated ivermectin plus another active treatment (doxycycline)

  • Type of publication: journal publication

  • Setting: inpatient

  • Recruitment dates: NR

  • Country: Bangladesh

  • Language: English

  • Number of centres: 1

  • Study purpose (treatment, prevention): treatment

  • Trial registration number: NA

  • Date of registration: NA

Participants
  • Number of participants (randomized/analyzed): 72/68 (relevant arms: 48/45)

  • Age (mean): overall 42 (SD NR) years

  • Males, n: overall 33 (46%)

  • Severity of condition according to study definition: hospitalized, no participants required oxygen

  • Severity of condition according to WHO scale: 4

  • Co‐morbidities: NR

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

  • Inclusion criteria: aged 18–65 years; admitted to hospital within last 7 days; presence of fever (37.5 °C), cough, sore throat, or a combination; diagnosed positive for SARS‐CoV‐2 by rRT‐PCR

  • Exclusion criteria: allergic to ivermectin or doxycycline, or if here was the potential for a drug–drug interaction with ivermectin or doxycycline; had chronic illnesses (e.g. ischaemic heart disease, heart failure, documented cardiomyopathy, chronic kidney disease, chronic liver disease); had received ivermectin or doxycycline (or both) in the last 7 days; were pregnant or lactating; or had participated in any other clinical trial within last month

Interventions
  • Details of intervention for relevant arms

    • Type and dose: ivermectin 12 mg, once daily for 5 days

    • Route of administration: oral

  • Treatment details of control group 

    • Placebo

  • Concomitant therapy: NA

  • Duration of follow‐up: NR

  • Treatment cross‐overs: none

Outcomes
  • Primary study outcome

    • Time to viral clearance

    • Remission of fever and cough within 7 days

  • Relevant review outcomes reported

    • Worsening of clinical status (need for oxygen) at 14 days

    • Serious adverse events within 14 days

    • Duration of hospitalization

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

  • Additional study outcomes reported

    • Proportion of participants with remission of fever, cough, and sore throat

    • Time to viral clearance (hazard ratio)

    • Blood biomarkers were measured on enrolment and on day 7 CRP, ferritin, LDH, and procalcitonin)

Notes
  • Date of publication: 2 December 2020

  • Sponsor/funding: Beximco Pharmaceutical Limited, Bangladesh

  • Correspondence with the author team: author request sent (follow‐up period for serious adverse events and mortality, details on baseline characteristics); no response received from author

  • Information on ethics votum: name of responsible ethics committee reported; no reference number of proposal or votum provided in publication. Sent author request; no response received