RECOVER-AUTONOMIC Platform Protocol

Korábbi kezelés

• Clinically significant atherosclerotic disease, defined as history of stroke or myocardial infarction or revascularization 6 months prior to enrollment and/or current symptomatic angina

Más betegség

• Known active acute SARS-CoV-2 infection ≤ 4 weeks from enrollment
• Known atrial fibrillation or significant cardiac arrhythmia
• Known cardiovascular conditions such as heart failure (Class 3-4), severe valvular disease
• Existing uncontrolled hypertension
• Any condition that the investigator believes makes it inappropriate to treat with study intervention, including severe debility.
• History of POTS or significant dysautonomia before COVID-19 index infection

Laborértékek

• Known renal failure (eGFR <20ml/1.73 m²)

Egyéb

• Known pregnancy, breast-feeding, or contemplating pregnancy during the study period
• Inability to comply with the protocol
• Enrolled in another clinical trial or another study intervention appendix in this platform protocol * Patients who are a part of observational studies (e.g. imaging) may be included in this trial. Participants may enroll in another interventional trial or re-enroll in this trial for a different study intervention appendix 30 days after end of study (Follow-up visit).

• ≥ 18 years of age at the time of enrollment
• 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:
  • 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. 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 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.
• Moderate, self-identified autonomic symptoms (defined as COMPASS-31 >20) following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent
• OHQ/OIQ, question 1 score >2