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Corticosteroid Nasal Spray in COVID-19 Anosmia

Primary Purpose

Covid19, Anosmia

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

mometasone furoate nasal spray

About this trial

This is an interventional treatment trial for Covid19 focused on measuring covid19, anosmia, mometasone nasal spray

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

adults 18 yrs or older patients
confirmed case (+ve PCR),
recovered/discharged (2 -ve PCR),
suffered from sudden recent anosmia or hyposmia

Exclusion Criteria:

patients already on nasal steroid
with previous chronic rhinological pathologies,
patients on systemic steroid for previous systemic disease,
anosmia improved before COVID19 recovery,
pregnancy
patients who will not complete the follow up period.

Sites / Locations

Benha University Hospital, Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mometasone nasal spray

control

Arm Description

Patients will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) in appropriate dose of 2 puff in each nostril (100 µg once daily) beside olfactory training.

Patients will not receive topical corticosteroid nasal spray but only olfactory training.

Outcomes

Primary Outcome Measures

improvement of olfaction

The patient will report the degree of anosmia subjectively with score on a scale from 0 to 10 (0 means total loss of smell and 10 refers to completely normal smell sensation).

Secondary Outcome Measures

Full Information

NCT ID

NCT04484493

First Posted

July 22, 2020

Last Updated

November 11, 2020

Sponsor

Benha University

1. Study Identification

Unique Protocol Identification Number

NCT04484493

Brief Title

Corticosteroid Nasal Spray in COVID-19 Anosmia

Official Title

Role of Corticosteroid Nasal Spray in Recovery of Smell Sensation in COVID-19 Patients

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

August 8, 2020 (Actual)

Primary Completion Date

October 25, 2020 (Actual)

Study Completion Date

November 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The aim of this study is to evaluate the role of the topical corticosteroids nasal spray (mometasone furoate nasal spray) in improving anosmia in patients recovered from COVID-19 infection.

Detailed Description

This study willbe submitted on patients who recently recovered from proven COVID-19 infection and complaining of anosmia or hyposmia.The proven COVID-19 infection will be relied on a positive real-time reverse transcription polymerase chain reaction (rRT-PCR) with samples obtained by a nasopharyngeal swab. The recovery is defined as 2 consecutives negative (rRT-PCR) samples. Complete medical history will be taken, and essential clinical assessment with appropriate protective measures will be performed in all patients.The patients in the study will be randomly divided into two groups: - Group I: -who will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) beside olfactory training Group II: -who will not receive topical corticosteroid nasal spray but only olfactory training. As regards the assessment of smell,the patient will assess his smell sensation using familiar substances with distinctive odor. A jar of coffee, a branch of mint and garlic are some used substances. The patient will report the degree of anosmia subjectively with score on a scale from 0 to 10.The assessment of smell will be done initially after recovery/discharge, after 1 week, 2 weeks and after 3 weeks for all patients. The duration of smell loss will be recorded from the onset of anosmia till full recovery of the sensation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, Anosmia

Keywords

covid19, anosmia, mometasone nasal spray

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mometasone nasal spray

Arm Type

Experimental

Arm Description

Patients will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) in appropriate dose of 2 puff in each nostril (100 µg once daily) beside olfactory training.

Arm Title

control

Arm Type

No Intervention

Arm Description

Patients will not receive topical corticosteroid nasal spray but only olfactory training.

Intervention Type

Drug

Intervention Name(s)

mometasone furoate nasal spray

Other Intervention Name(s)

steroid nasal spray

Intervention Description

dose of 2 puff in each nostril (100 µg once daily each nostril).

Primary Outcome Measure Information:

Title

improvement of olfaction

Description

The patient will report the degree of anosmia subjectively with score on a scale from 0 to 10 (0 means total loss of smell and 10 refers to completely normal smell sensation).

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: adults 18 yrs or older patients confirmed case (+ve PCR), recovered/discharged (2 -ve PCR), suffered from sudden recent anosmia or hyposmia Exclusion Criteria: patients already on nasal steroid with previous chronic rhinological pathologies, patients on systemic steroid for previous systemic disease, anosmia improved before COVID19 recovery, pregnancy patients who will not complete the follow up period.

Overall Study Officials: