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Table 1 Patient, caregiver, and healthy volunteer inclusion and exclusion criteria

From: Development of a novel patient-reported outcome measure to assess signs and symptoms of COVID-19

Inclusion criteria

Exclusion criteria

Adult patients (aged ≥ 18 years) self-reporting a positive SARS-CoV-2 PCR test in the 2 weeks prior to screening and experiencing ≥ 2 current, bothersome symptoms due to COVID-19

Participated in a study with any investigational medicinal product in the previous 30 days


Caregivers reporting ≥ 2 COVID-19 symptoms with a positive PCR test for SARS-CoV-2 on behalf of their patient(s)


Healthy volunteers aged ≥ 18 years


Willing and able to participate in a 1-h interview via telephone or an online method


Willing to provide a self-reported medical history


Able to read, speak, and understand English


Willing and able to provide informed consent

  1. Inclusion criteria, including self-reported positive PCR for SARS-CoV-2 and a checklist of current COVID-19 symptoms were presented in the recruitment screener. The most bothersome symptoms were also explored during concept elicitation. Participants described all symptoms they were experiencing and were subsequently asked which were the most bothersome. Consistently, participants distinguished a single symptom that was most bothersome to them, rather than providing a list
  2. Abbreviations: SARS-CoV-2 severe acute respiratory syndrome coronavirus 2, PCR polymerase chain reaction, COVID-19 coronavirus disease 2019