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. 2021 Jul 22;2021(7):CD013876. doi: 10.1002/14651858.CD013876.pub2

IRCT20200522047542N1.

Study name Effect of inhaled corticosteroids in the treatment of anosmia in patients with COVID‐19
Methods Parallel‐group randomised controlled trial
Participants Individuals with COVID‐19, confirmed by RT‐PCR testing or COVID‐19 IgG/IgM Rapid Test Cassette who had persistent (more than 30 days) olfactory dysfunction
Inclusion criteria:
  • Aged 18 to 65 years

  • Patients with COVID‐19 who have been referred or admitted to Qaem, Imam Reza or Shariati Hospital diagnosed with a protocol defined by the World Health Organization

  • Confirmed COVID‐19 cases by positive RT‐PCR or the COVID‐19 IgG/IgM Rapid Test Cassette

  • Have not experienced any signs of reduced sense of smell and taste for at least 2 weeks before the onset of the first manifestation of COVID‐19

  • Diagnosed with hyposmia or anosmia (persisting for more than 30 days)


Exclusion criteria:
  • People with certain underlying conditions, such as: Parkinson's, Alzheimer's, severe nutritional disorders, acute rhinitis, acute catarrhal sinusitis, SICA syndrome (especially after radiation), nasal mucosal congestion, for example after rhinoplasty, olfactory nerve damage in trauma, etc.

  • People who experienced other viral and bacterial infections simultaneously with COVID‐19

  • History of asthma and allergies

  • Refusal to participate in follow‐up, provide data or withdrew consent


Planned sample size: estimated enrolment 70 participants
Interventions Intervention:
  • Intranasal corticosteroid spray (0.05% mometasone), one puff twice daily in each nostril for 4 weeks


Comparator:
  • Intranasal sodium chloride spray (0.65%, Decosalin), one puff twice daily in each nostril for 4 weeks

Outcomes Outcomes of interest in the review:
Primary outcomes:
Recovery of sense of smell
  • Not reported


Disease‐related quality of life
  • Not reported


Serious adverse effects
  • Not reported


Secondary outcomes:
Change in sense of smell
  • Assessed with a 10‐point VAS (0 = worst, 10 = best)

  • Measured at day 7, 14 and 30 after treatment


Overall, generic quality of life
  • Not reported


Prevalence of parosmia
  • Not reported


Other adverse effects (including nosebleeds/bloody discharge)
  • Not reported


Other outcomes reported by the study:
  • None reported

Starting date 18 July 2020
Contact information Dr Masoomeh Hosseinpoor
Email: drmh2018@gmail.com
Notes Trial registered in Iran
Estimated recruitment end date: 18 September 2020