RECOVER-AUTONOMIC Platform Protocol

Launched by KANECIA OBIE ZIMMERMAN · Mar 8, 2024

Keywords

ClinConnect Summary

The RECOVER-AUTONOMIC clinical trial is studying ways to help people who are experiencing ongoing health issues after recovering from COVID-19, often referred to as Long COVID. Specifically, this trial focuses on symptoms related to the autonomic nervous system, which controls functions like heart rate and blood pressure. Participants will be evaluated for various treatments, including both medication and non-medication options, to see which ones might improve their symptoms.

To be eligible for this trial, participants need to be at least 18 years old and have had COVID-19, along with moderate ongoing symptoms related to their autonomic nervous system for at least 12 weeks. They should not have certain serious health conditions, like severe heart problems or recent blood clots. Those who join can expect to receive care from a team of healthcare professionals and will be randomly assigned to different treatment groups to help researchers determine the best options. This research aims to find effective ways to support individuals struggling with Long COVID symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ≥ 18 years of age at the time of enrollment
• • 2. Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization12ɸ ɸ Enrollment of participants with suspected or probable SARS-CoV-2 infection will only be allowed if they occurred before May 1, 2021 and be limited to no more than 10% of the total sample size per Study Drug Appendix. Refer to the Manual of Procedures (MOP) for details.
• Suspected case of SARS-CoV-2 infection - Three options, A through C:
• • A. Meets the clinical OR epidemiological criteria.
• • 1. 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.
• • 2. Epidemiological criteria: Contact of a probable or confirmed case or linked to a COVID-19 cluster; or B. Presents with 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. Presents 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, defined as 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:
• • A. A person with a positive nucleic acid amplification test, regardless of clinical criteria OR epidemiological criteria; or B. Meeting clinical criteria AND/OR epidemiological criteria (See suspect case A). With a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test.
• • 3. Moderate, self-identified autonomic symptoms (defined as COMPASS-31 \>25) following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent
• • 4. OHQ/OIQ, question 1 score \>2
• Exclusion Criteria:
• • 1. Known pregnancy, breast-feeding, or contemplating pregnancy during the study period
• • 2. Known active acute SARS-CoV-2 infection ≤ 4 weeks from enrollment
• • 3. Known renal failure (eGFR \<20ml/1.73 m²)
• • 4. Known atrial fibrillation or significant cardiac arrhythmia
• • 5. Known cardiovascular conditions such as heart failure (Class 3-4), severe valvular disease, symptomatic ischemic coronary artery disease, revascularization for PAD/CAD within the past 6 months
• • 6. Clinically significant atherosclerotic disease, defined as history of stroke or myocardial infarction or revascularization 6 months prior to enrollment and/or current symptomatic angina
• • 7. Existing uncontrolled hypertension
• • 8. History of significant hypercoagulability disorders
• • 9. Active or recent thrombosis