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# Guidance on Assessing Covid Symptoms in Clinical Trials
- URL: https://www.fdaweb.com/guidance-on-assessing-covid-symptoms-in-clinical-trials/
- Published: 2020-09-14T12:00:00.000Z
- Updated: 2026-09-14T16:28:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147645

FDA has released a [final guidance ](https://www.fda.gov/media/142143/download?ref=fdaweb.com)on *Assessing Covid-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for Covid-19 Prevention or Treatment.* The document notes that sponsors may encounter challenges in identifying methods to assess the numerous and heterogeneous Covid-19-related symptoms across subjects when designing clinical trials for drugs to treat or prevent Covid-19\. “In many instances, daily assessment of all Covid-19-related symptoms may not be feasible,” it says.

The guidance recommends that sponsors identify a minimum number of key symptoms for daily assessments to lessen burden on trial subjects. To assist sponsors, the document provides an example with a set of common Covid-19-related symptoms as well as an approach to their measurement for use in clinical trials. The symptom items were compiled using information provided by the Centers for Disease Control and Prevention. They include using patient-reported outcome (PRO) instruments8 to assess Covid-19-related symptoms, and using electronic data collection systems with reminders to trial subjects to complete the PRO instrument to minimize missing data and provide time stamps of completion.