NCT04844541

Prophylaxis and Treatment of COVID-19

Prophylaxis and Treatment of COVID-19 - Adaptive Platform Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 450 (actual)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

An observation study evaluating physiologic responses and host biomarker expression patterns in early SARS-CoV-2 and acute respiratory infections (ARI) and among their close contacts.

Detailed description

The aim of this observational study is to characterize the clinical, biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 infection in cases and their close contacts. The incorporation of novel technologies including self-specimen collection, symptom self-reporting, remote physiologic monitoring and virtual interaction with participants will enhance the capacity to conduct remote clinical trial activities. Inclusion of these remote and virtual elements into clinical trials augment the capacity to conduct much needed clinical research during times of resource strain such as a global pandemic. PROTECT-APT will be conducted as a multi-site study coordinated centrally by the Henry M Jackson Foundation for the Advancement of Military Medicine.

Conditions

• COVID-19
• Acute Respiratory Infection

Timeline

• Start date: 2021-06-11
• Primary completion: 2024-02-21
• Completion: 2024-02-21
• First posted: 2021-04-14
• Last updated: 2025-04-24

Locations

3 sites across 2 countries: United States, Thailand