Design of the Clinical Trials

The RECOVER Initiative’s 8 clinical trials will explore 13 study interventions, or possible treatments, for post-acute sequelae of SARS-CoV-2 infection (PASC), known as Long COVID.

Study interventions include study drugs, medical devices, and other approaches. Some study interventions are repurposed drugs—medicines approved by the U.S. Food and Drug Administration (FDA) to treat health conditions that are not related to Long COVID. Each of the repurposed drugs in RECOVER clinical trials must be studied as a possible treatment for Long COVID symptoms before the FDA can approve the drug to be used as a treatment for this health condition.

There are 5 RECOVER platform protocols with one or more appendix, or clinical trial, within the platform. The protocol for each platform describes the goals of the research, who can enroll, possible treatments, study activities, and more. Clinical trial sites are listed in the clinicaltrials.gov study records, linked below, and will be updated weekly as more sites are added to each trial. Study sites will contact potential participants in their local communities.

Clinical Trial

Description

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RECOVER-VITAL Viral Persistence (PAXLOVID)

PAXLOVID (nirmatrelvir and ritonavir) is an antiviral drug that works to stop the virus that causes COVID-19 from multiplying.

RECOVER-NEURO Cognitive Dysfunction (BrainHQ, PASC-CoRE, & tDCS)

BrainHQ is an interactive online brain training program designed to improve memory, attention, and brain processing speed.

PASC Cognitive Recovery (PASC-CoRE) is an online goal management training program.

Transcranial Direct Current Stimulation (tDCS) is a safe, noninvasive form of brain stimulation.

RECOVER-AUTONOMIC Severe POTS (IVIG)

Gamunex-C, a form of intravenous immunoglobulin (IVIG), is a repurposed drug that contains antibodies to help the body protect itself against infection from various diseases.

RECOVER-AUTONOMIC Moderate POTS (Ivabradine)

Ivabradine is a repurposed drug that reduces heart rate.

RECOVER-SLEEP Hypersomnia (Modafinil/Solriamfetol)

Modafinil and solriamfetol are repurposed drugs used to help people stay awake during the day.

RECOVER-SLEEP Complex Sleep Disturbances (Melatonin + Light Therapy)

Melatonin is a natural hormone in the brain that helps regulate the timing of sleep. Light therapy is exposure to a bright light that may help improve and regulate sleep-wake patterns.

RECOVER-ENERGIZE Exercise Intolerance (Personalized Cardiopulmonary Rehabilitation)

Personalized Cardiopulmonary Rehabilitation is a program that combines exercise training with education to help participants with exercise intolerance improve their quality of life and ability to exercise. The program is tailored to the participant’s level of functioning and progress.

RECOVER-ENERGIZE Post-Exertional Malaise (Structured Pacing)

Structured Pacing is a program to help participants get to know, control, and minimize PEM symptoms with the assistance of a Pacing Coach. The goal of the program is to help people experience more stable function in everyday life with less frequent and less severe PEM symptoms.

This page will be updated as the clinical trials progress. Sign up for the RECOVER Report to get monthly emails with the latest information about all RECOVER research, including clinical trials.