COVID-19: RECOVER-AUTO: A Platform Protocol for Evaluation of Interventions for Autonomic Dysfunction in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

Grants and Contracts Details

Description

Human Clinical Trial - Confidential. RECOVER-AUTO Abstract John Thompson, 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 in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. The hypothesis is that some of the autonomic dysfunction symptoms are immune-mediated, so immunotherapy and other applicable therapies will result in improvement in autonomic symptoms. Primary Objective: 1. Evaluate the effect of study intervention versus control on orthostatic intolerance Secondary Objective: 1. Evaluate the effect of study intervention versus control on symptom-specific outcome measures 2. Describe the effect of study intervention versus control on performance-based and vital sign outcome measures 3. Evaluate the effect of study intervention versus control on quality of life 4. Compare the effect of study intervention versus control on specific tracked measurements 5. Characterize the safety and tolerability of study intervention for treatment of PASC Exploratory Objective: 6. Evaluate the effect of study intervention versus control on autonomic function tests 7. Evaluate the effect of study intervention versus control on relevant biomarkers
StatusActive
Effective start/end date10/1/2312/31/24

Funding

  • Duke University: $34,500.00

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