Oral Isotretinoin and Covid-19 Infection

NCT04663906 | Unknown

• 1 other identifier: 1/095/20
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is a theoretical risk that the nasal mucosal dryness caused by oral retinoid medications may increase the risk of patients becoming infected with Covid-19. Isotretinoin is a drug used commonly in dermatology, usually for management of acne and occasionally for management of other dermatological diseases. The most common side effect of oral isotretinoin is mucocutaneous dryness, which can lead to nasal dryness and crusting. Isotretinoin is derived from vitamin A and produces this side effect by arresting the cell cycle of mucus secreting cells in the nasal cavity. The mucus usually secreted moisturises the nasal cavity and provides a protective, lubricating layer overlying the cilia. Cilia and nasal mucous are both believed to have roles in defence against infection and immunity. Hence it was postulated at the start of the pandemic that the effect this medication has on the nasal environment may increase the likelihood of contracting a disease spread by droplet or aerosol particles. In March 2020 we established a departmental Excel database of our patients on oral retinoid medications in order to track those currently receiving treatment. The database includes people taking isotretinoin, alitretinoin and acitretin. The greatest number of patients in this database are in the isotretinoin group and patients taking isotretinoin tend to be a relatively young and fit population. Acitretin on the other hand is often used in an older population who may have other underlying disease comorbidities. There were only a very small number of patients taking alitretinoin in the database. In order to limit confounding variables and provide as clear a result as possible, it was decided to limit this study to comparing the group of patients taking isotretinoin, aged 16-40years, with an age-matched background population from NHS Grampian. This study would examine the electronic patient record of patients aged 16-40years, taking isotretinoin between March and October 2020 and compare their rates of Covid-19 infection, hospitalisation and complications with the rates of the local age-matched background population. Persons taking isotretinoin in the time period would be excluded from the background population. As Covid-19 is a new disease, the existing research literature on this specific topic is extremely limited, and so far this study would be the first in this area.

Conditions

Isotretinoin Adverse Reaction; Covid19

Keywords

isotretinoin; Covid19; coronavirus; covid-19

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Did patients taking isotretinoin have a greater risk of infection with Covid-19 compared to an age-matched background population not taking isotretinoin.

  March - October 2020

Secondary Outcomes (1)

• Secondary Outcome

  March - October 2020

Study Arms (2)

Isotretinoin

Test population, prescribed oral isotretinoin between March and October 2020.

Control

Background age-matched population, not prescribed oral isotretinoin during March to October 2020

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This is an estimate based on the number of patients taking isotretinoin aged 16-40 we have in the departmental database. We would try and obtain equal numbers in the isotretinoin and background populations as far as possible, roughly 125 patients who received isotretinoin and 125 background patients who did not. The numbers in each population can only be finally determined when the database is interrogated and details are obtained from Health Intelligence, neither of which can happen prior to approvals

You may qualify if:

• Test: prescribed oral isotretinoin in NHS Grampian age 16-40years includive, between March-Oct 2020
• Background control population: residing in NHS Grampian, age 16-40years, etsted for Covid-19 between march -oct 2020, not prescribed oral isotretinoin in timeframe.

You may not qualify if:

• Test population: not prescribed oral isotretinoin in NHS grampian, outwith age range 16-40years or treatment range March-October 2020.
• Background control popuat8ion: prescribed oral isotretinoin between march-october 2020, age outwith 16-40years, not tested for covid-19 between March-Oct 2020.

Sponsors & Collaborators

• University of Aberdeen: lead

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Louise King

CONTACT

researchgovernance@abdn.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 11, 2020
• Study Start: January 15, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share