Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-25 @ 11:58 AM
NCT ID:
NCT04828161
Pre Assignment Details:
The Part A of the study consisted of a screening period (up to 3 days) followed by study treatment on Day 1. Participants were randomized in 1:1:1:1 ratio, stratified by risk for COVID-19 disease progression, to receive 1 of 4 study treatments (Ensovibep 600 mg or Ensovibep 225 mg or Ensovibep 75 mg or Placebo). A total of 407 participants were randomized in the study, of which 400 were treated.
Recruitment Details:
This study consisted of 2 parts, Part A and Part B. The Part A was Phase II proof of efficacy study conducted in ambulatory adult participants with symptomatic coronavirus disease 2019 (COVID-19) at 45 centers across 5 countries (Hungary, India, Netherlands, South Africa, and USA) between 10 May 2021 and 27 Jan 2022. The Part B was to be a Phase III confirmatory study. Only Part A analysis is reported since Part B of the study was not initiated.
Study:
NCT04828161
Study Brief:
Results Section:
NCT04828161