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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT04771351
Eligibility Criteria:
Inclusion Criteria:
* Positive for COVID-19 by an approved antigen test
* Progressive disease suggestive of ongoing COVID-19 infection
* Requires hospitalization for acute medical care
* Provides written informed consent
* Willing to follow contraception guidelines during study
Exclusion Criteria:
* Requires high-flow oxygen supplementation
* Current or imminent respiratory failure
* Has rapidly progressing symptoms that in the investigator's opinion are likely to progress to needing high-flow oxygen or to respiratory failure within 24 to 48 hours
* Any condition which, in the investigator's opinion, participation would not be in the subject's best interest or could prevent, limit, or confound the protocol-specified assessments
* Has participated, or is participating in, a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies against SARS-CoV-2, or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer)
* Pregnant or lactating and breast feeding, or planning on either during the study
* Unable to comply with planned study procedures and be available for all follow-up visits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04771351
Study Brief:
Protocol Section:
NCT04771351