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

Pott‐Junior 2021.

Study characteristics
Methods
  • Trial design: open‐label RCT with 4 parallel arms, the 3 intervention arms were pooled for this review

  • Type of publication: journal publication

  • Setting: inpatient

  • Recruitment dates: July to December 2020

  • Country: Brazil

  • Language: English

  • Number of centres: 1

  • Study purpose (treatment, prevention): treatment

  • Trial registration number: NCT04431466

  • Date of registration: 16 June 2020

Participants
  • Number of participants (randomized/analyzed): 32/31

  • Age (mean): overall 49 (SD 14.6) years

  • Males, n: overall 17 (45%)

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

  • Severity of condition according to WHO scale: unclear; available information: minimum category 4, 20% in category 5

  • Co‐morbidities: NR

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

  • Inclusion criteria: diagnosis of infection by SARS‐CoV‐2 by symptoms of acute respiratory tract infection (sudden onset of ≥ 1 of the following: cough, fever, shortness of breath) and biomolecular diagnosis of SARS‐CoV‐2 infection or any acute respiratory disease AND biomolecular diagnosis of SARS‐CoV‐2 infection or severe acute respiratory infection (fever and ≥ 1 sign/symptom of respiratory disease, e.g. cough, fever, shortness of breath); need of hospitalization; biomolecular diagnosis of SARS‐CoV‐2 infection; Eastern Cooperative Oncology Group Performance Status score 0 to 1; National Early Warning Score 0–4; ability to understand and consent to participate in this clinical trial, manifested by signing the informed consent form.

  • Exclusion criteria: inability to ingest study drug orally through spontaneous ingestion or use of enteral tubes; risk to participant in the trial judged by physician, based on patient history, clinical observation, laboratory test findings, ECG examination; known hypersensitivity to the components of the drugs used during the study; women in pregnancy or breastfeeding; bodyweight < 15 kg; estimated glomerular filtration rate < 30 mL/minute; AST or ALT > 5 times the upper limit of normality; refusal to participate or to sign the informed consent form

Interventions
  • Details of intervention

    • Type and dose: ivermectin 0.1 mg/kg, 0.2 mg/kg, and 0.4 mg/kg cumulative over 72 hours, unclear frequency scheme (pooled)

    • Route of administration: oral

  • Treatment details of control group

    • No treatment except standard of care

  • Concomitant therapy: standard of care including thromboprophylaxis, steroids, antibiotics administered in both study arms, but unbalanced between groups

  • Duration of follow‐up: 28 days

  • Treatment cross‐overs: none

Outcomes
  • Primary study outcome

    • Time to RT‐PCR negativity

  • Relevant review outcomes reported

    • Viral clearance (RT‐PCR) at 7 days

    • Adverse events within 28 days

    • ICU admission within 28 days

  • Additional study outcomes reported

    • Viral load variation clearance in nasopharyngeal swab at 7 days

    • Time to undetectable viral load in nasopharyngeal swab at 7 days

    • Change in cycle threshold values (RT‐PCR) within 7 days

Notes
  • Date of publication: 9 March 2021

  • Sponsor/funding: Federal University of Sao Carlos, Brazil

  • Correspondence with the author team: author request sent (details of intervention, especially deviations between protocol and publication); no response received from the author

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