Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT04969250
Eligibility Criteria:
Inclusion Criteria:
* Participating in the ACTIV-3/TICO trial and received a selected blinded investigational agent, or placebo for that agent, at selected sites.
* Willingness to strictly adhere to the randomly allocated dosage number and schedule for vaccine administration.
* Participant is between Day 28 and Day 90 TICO visits inclusive at time of randomization.
* At time of screening for this study, has experienced sustained recovery (i.e., the primary endpoint in TICO) for at least two consecutive weeks, i.e. having returned uninterrupted to the person's premorbid living facility (or equivalent) for at least 2 consecutive weeks.
* Ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures.
Exclusion Criteria:
* Receipt of a SARS-CoV-2 (COVID-19) vaccine after enrollment into TICO. Participants who received a SARS-CoV-2 vaccine prior to enrollment in TICO may be enrolled in this study.
* Known allergy to any component of the study eligible vaccine(s).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04969250
Study Brief:
Protocol Section:
NCT04969250