COVID 19: RECOVER-VITAL: A Platform Protocol for Evaluation of Interventions for Viral Persistence, Viral Reactivation, and Immune Dysregulation in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

Human Clinical Trial - Confidential. RECOVER-VITAL Abstract Christopher R. Simmons, MD Principal Investigator This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol describes a prospective, multi-center, multi-arm, double-blind, randomized, controlled, platform trial, with different interventions organized as appendices to the protocol. Each appendix evaluates potential mechanisms of action, efficacy, and safety of antivirals and other therapeutics in individuals with PASC, according to the platform protocol objectives. The hypothesis is that persistent viral infection and/or overactive/chronic immune response and inflammation are underlying contributors to PASC and that antiviral and other applicable therapies may result in viral clearance or decreased inflammation and improvement in PASC symptoms.