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

Kishoria 2020.

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

  • Type of publication: journal publication

  • Setting: inpatient

  • Recruitment dates: NR

  • Country: India

  • 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): 35/32

  • Age (mean): overall 38 (SD NR) years

  • Males, n: overall 23 (72%)

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

  • Severity of condition according to WHO scale: 4 including people without symptoms

  • Co‐morbidities: NR

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

  • Inclusion criteria: men or women, aged ≥ 18 years; tested positive after completion of standard care treatment for SARS‐CoV‐2 confirmed by RT‐PCR assay; mild symptoms or asymptomatic; no comorbidities affecting the patient's prognosis, rendering them at high risk; documented acceptance to participate by means of the execution of the informed consent

  • Exclusion criteria: allergy or hypersensitivity to ivermectin or its inactive ingredients, or both; respiratory distress or requiring intensive care; used immunosuppressants (including systemic corticosteroids) in the last 30 days; known HIV infection with CD4 count < 300 cell/L; pregnancy or lactating women; medical conditions such as mal‐absorption syndromes affecting proper ivermectin absorption; autoimmune disease or decompensated chronic diseases, or both; uncontrolled, intercurrent diseases including renal impairment, hepatic impairment, symptomatic congestive heart failure, unstable chest angina, or heart arrhythmia; treated in any other study in the previous 30 days; concomitant administration of enzyme inducers (such as carbamazepine) that could affect the effectiveness of the drug and people receiving CYP3A4 substrates (such as statins) due to the risk of increased toxicity

Interventions
  • Details of intervention for relevant arms

    • 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 hydroxychloroquine, vitamin C, and paracetamol administered in both study arms

  • Duration of follow‐up: 6 days

  • Treatment cross‐overs: none

Outcomes
  • Primary study outcome

    • Negative throat swab report for SARS‐CoV‐2 conducted by RT‐PCR after 48 hours of day 1 of research therapy

  • Relevant review outcomes reported

    • Viral clearance at 3 days

  • Additional study outcomes reported

    • Viral clearance at 5 days

    • Hospitalization status at end of study

Notes
  • Date of publication: August 2020

  • Sponsor/funding: NR

  • Correspondence with the author team: author request sent (date of recruitment, reason for withdrawals, baseline characteristics regarding compensated comorbidities, reason for missing patients at 5 days); no response received from the author

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