Overview:
This document summarizes the inclusion/exclusion criteria for study populations in five published COVID-19 (C-19) Phase 3 efficacy trial protocols and one summary document published by CEPI on the inclusion of at-risk populations in C-19 efficacy trials. Trial participants should meet all inclusion criteria and no exclusion criteria. These criteria cover areas such as age, comorbidities, reproductive health, baseline SARS-CoV-2 serostatus, race, and ethnicity.
The BioNTech/Pfizer protocol includes a minimum enrolment age of 12 years, while only subjects aged ≥18 years are included in the Moderna, Janssen, AstraZeneca (AZ)/Oxford, and Novavax protocols. No upper age limit is defined in the US-based protocols (BioNtech/Pfizer, Moderna, Janssen, and AZ/Oxford); however, the UK-based Novavax protocol defines an upper limit of 84 years for recruitment.
All protocols and the CEPI document recommend enrolment of subjects with stable pre-existing health conditions, but the definition of stable disease differs. Underlying comorbidities include for example obesity, diabetes, hypertension, cardiovascular diseases, and chronic respiratory, liver and kidney disease. The definition of stable disease in the Moderna, Janssen, and AZ/Oxford protocols and the CEPI document requires no therapy change or hospitalization for worsening of comorbidities for three months prior to enrolment, whilst the BioNtech/Pfizer and Novavax protocols require six and four weeks of stable treatment, respectively. The AZ/Oxford and Novavax protocols allow for inclusion of mild to moderate, well-controlled comorbidities.
Use of appropriate contraception by female subjects is required for 28 days prior to enrolment in all protocols, and this must be continued until 28 days after the second dose in the BioNTech/Pfizer protocol, two months after the second dose in the AZ/Oxford protocol, and three months after a single dose in the Janssen protocol and second dose in the Moderna and Novavax protocols. The latter protocols also consider representative enrolment of racial and ethnic minorities.
The Moderna, AZ/Oxford, and Novavax protocols recommend exclusion of subjects with a known history of SARS-CoV-2 infection. The Pfizer/BioNTech protocol excludes previous C-19, while all protocols enrol without knowing baseline SARS-CoV-2 serostatus. The Janssen protocol recommends unique exclusion criteria for underlying conditions for stage 1A and 2A of enrolment. The CEPI document, similar to the US-FDA guidance, recommends that trials do not screen for or exclude participants with history or laboratory evidence of prior SARS-CoV-2 infection. All protocols recommend the inclusion of HIV positive subjects on stable antiretroviral treatment.
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