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. 2022 Jun 21;2022(6):CD015017. doi: 10.1002/14651858.CD015017.pub3

NCT05041907.

Study name Finding treatments for COVID‐19: a trial of antiviral pharmacodynamics in early symptomatic COVID‐19 (PLATCOV) (PLATCOV)
Methods
  • Trial design: open‐label RCT with 5 parallel arms, only 2 arms relevant; the third arm investigates favipavir, the fourth arm arms investigates remdesivir, the fifth arm investigates monoclonal antibodies

  • Type of record: trial register entry

  • Sample size: 750

  • Setting:outpatient

  • Country: Thailand

  • Language: English

  • Number of centres: NR

  • Study purpose (treatment, prevention): treatment

  • Trial registration number: NCT05041907

  • Date of registration: 13 September 2021

Participants
  • Inclusion criteria

    • Patient understands the procedures and requirements and is willing and able to give informed consent for full participation in the study

    • Previously healthy adults, male or female, aged 18‐50 years at time of consent with early symptomatic COVID‐19

    • SARS‐CoV‐2 positive by lateral flow antigen test

    • Symptoms of COVID‐19 (including fever, or history of fever) < 4 days (96 hours)

    • Oxygen saturation ≥ 96% measured by pulse oximetry at time of screening

    • Able to walk unaided and unimpeded in activities of daily living

    • Agrees and is able to adhere to all study procedures, including availability and contact information for follow‐up visits

  • Exclusion criteria

    • Taking any concomitant medications or drugs

    • Presence of any chronic illness/ condition requiring long‐term treatment, or other significant comorbidity

    • Laboratory abnormalities discovered at screening

    • For females: pregnancy, actively trying to become pregnant, or lactation

    • Contraindication to taking, or known hypersensitivity reaction to any of the proposed therapeutics

    • Currently participating in another COVID‐19 therapeutic or vaccine trial

    • Evidence of pneumonie (although imaging is not required)

Interventions
  • Details of intervention of relevant arms

    • Type and dose: ivermectin 0.6 mg/kg, once daily for 7 days

    • Route of administration: oral

  • Treatment details of control group

    • No treatment except standard of care

  • Concomitant therapy: standard of care (supportive care only) administered in both study arms

Outcomes
  • Primary study outcome

    • Rate of viral clearance for repurposed drugs within 7 days

    • Rate of viral clearance of positive control (monoclonal antibodies) over time relative to the negative control within 7 days

    • Rate of viral clearance for small novel molecule drugs within 7 days

  • Relevant review outcomes planned

    • Rates of hospitalization by treatment arm within 28 days

    • Viral cleareance

  • Additional study outcomes

    • Viral kinetic levels in early COVID‐19 disease within 7 days

    • Number of antiviral treatment arms that show a positive signal (> 90% probability of > 5% acceleration in viral clearance) within 7 days

    • Rates of viral clearance by treatment arm, as compared against REGN‐COV2 (monoclonal antibody cocktail) within 7 days

    • Rates of hospitalization by treatment arm within 28 days

Starting date 30 September 2021
Contact information Nicholas White 
Professor of Tropical Medicine at Mahidol University 
Phutthamonthon 
Thailand
Notes
  • Recruitment status: recruiting

  • Prospective completion date: August 2023

  • Planned completion date more than 6 months ago: no

  • Date last update posted: 12 January 2022

  • Sponsor/funding: University of Oxford