OBJECTIVES: A targeted literature search was conducted to assess the availability of Long COVID symptom diaries. In consultation with the EMA, one was needed to support outcome evaluation for inclusion as a secondary endpoint in a clinical trial of a product’s efficacy in Long-COVID. The objective of this review was to identify and potentially re-purpose an existing symptom diary.

METHODS: A search of both PubMed and ePROVIDE was conducted in January 2021 covering a period of approximately 1 year from the onset of the SARS-CoV-2 pandemic in the US. PubMed is a search engine accessing primarily the MEDLINE database of references and is maintained by the US National Library of Medicine. ePROVIDE is a proprietary commercially-available database that references over 5,600 validated and published Clinical Outcomes Assessments.

RESULTS: Only 2 published Long COVID symptom diaries were identified. Subsequent applications for licensing submitted to both copyright holders were denied for various reasons; therefore, a new instrument needed to be rapidly developed. The only publicly available instrument for COVID was the CDC’s acute COVID symptom questionnaire. We therefore conceptually extended and supplemented that instrument with additional symptoms of Long COVID as published in peer-reviewed epidemiological cohort studies. Thematic qualitative analyses were utilized to develop the new content for Long COVID symptoms and response scales were amended to better fit the disease.

CONCLUSIONS: The literature review, thematic analyses and pragmatic extension of the CDC’s acute COVID symptomatology instrument resulted in the rapid design of a novel Long COVID symptomology patient diary. Initial results of efficacy from the trial are expected in 2024, including results for the novel patient diary. In the emergence of unmet need, COA researchers may need to work creatively to repurpose existing instruments for use in clinical trials of emerging infectious diseases, particularly in the setting of a pandemic.