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)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Long COVID
- Sponsor
- Kanecia Obie Zimmerman
- Enrollment
- 963
- Locations
- 69
- Primary Endpoint
- Total Number of Participants Enrolled in Each Appendix
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
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, double-blind, randomized, controlled platform trial with different interventions organized as appendices to the protocol. Each appendix (or sub-study) 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, viral reactivation, 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.
Detailed Description
Participants will be randomized to study interventions or placebo/controls based on the arms that are actively enrolling at the time of randomization. Study interventions may be added or removed according to adaptive design and/or emerging evidence. When there are multiple study interventions available, randomization will occur based on appropriateness of each intervention for the participant as determined by the study protocol.
Investigators
Kanecia Obie Zimmerman
Associate Professor of Pediatrics
Duke University
Eligibility Criteria
Inclusion Criteria
- •≥ 18 years of age at the time of enrollment
- •Previous suspected, probably or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization\*
- •\*Suspected and probable cases will only be allowed if it occurred before May 1, 2021, and will be limited to 10% of the study population. Otherwise, confirmed cases are required.
- •Suspected case of SARS-CoV-2 infection - Three options, A through C:
- •A. A person who meets the clinical OR epidemiological criteria. Clinical criteria: Acute onset of fever AND cough (influenza-like illness) OR Acute onset of ANY THREE OR MORE of the following signs or symptoms: fever, cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, anorexia. Epidemiological criteria: Contact of a probable or confirmed case or linked to a COVID-19 cluster; or
- •B. Acute respiratory infection with history of fever or measured fever of ≥ 38°C; and cough; with onset within the last 10 days; and who requires hospitalization); or
- •C. With no clinical signs or symptoms, NOR meeting epidemiologic criteria with a positive professional use or self-test SARS-CoV-2 antigen-Rapid Diagnostic Test.
- •Probable case of SARS-CoV-2 infection:
- •A. A patient who meets clinical criteria above AND is a contact of a probable or confirmed case or is linked to a COVID-19 cluster.
- •Confirmed case of SARS-CoV-2 infection - Two options, A through B:
Exclusion Criteria
- •An individual who meets any of the following criteria will be excluded from participation in this study. Refer to appendices for additional appendix-level criteria:
- •Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent
- •Known severe anemia, defined as \< 8 g/dL
- •Meeting the following symptom cluster exclusion for all eligible clusters\*:
- •a. Cognitive dysfunction: known stroke that resulted in cognitive impairment within 3 months of enrollment b. Autonomic dysfunction: atrial fibrillation or significant cardiac arrhythmia, more than moderate alcohol consumption\*\*, pre-existing sustained severe hypertension (BP\> 180/110 mmHg in the sitting position) c. Exercise intolerance: i. any of the following within 4 weeks of consent - an acute myocardial infarction or unstable angina, uncontrolled arrhythmias causing symptoms or hemodynamic compromise, acute myocarditis or pericarditis, uncontrolled acutely decompensated heart failure (acute pulmonary edema), acute pulmonary embolism, suspected dissecting aneurysm, severe hypoxemia at rest, any acute or chronic disorder that may affect exercise performance ii. if the participant is aggravated by exercise (e.g., infection, thyrotoxicosis, unable to cooperate)
- •\*Participants who are eligible for \> 1 cluster must meet all inclusion and no exclusion criteria for an individual symptom cluster. If not, the participant will be excluded from that individual symptom cluster.
- •\*\* Defined as greater than 2 drinks a day for men and 1 drink a day for women. A drink is equivalent to 12 ounces of beer (5% alcohol content), 8 ounces of malt liquor (7% alcohol content), 5 ounces of wine (12% alcohol content), 1.5 ounces or a "shot" of 80-proof (40% alcohol content) distilled spirits or liquor (e.g., gin, rum, vodka, whiskey). 21
- •Known diagnosis of chronic Lyme disease with persistent symptoms, sequelae, or related therapy
- •Any non-marijuana illicit drug use within 30 days of informed consent
- •Current or recent use (within the last 14 days) of study intervention\*
Outcomes
Primary Outcomes
Total Number of Participants Enrolled in Each Appendix
Time Frame: 90 days
Appendix-specific outcome measure data will be reported under the associated NCT ID.