Ensayos clínicos

Inclusion Criteria:

• ≥ 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 Organization.
• 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
  • 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
  • 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: RECOVER-AUTO Version 1.0
• A person with a positive nucleic acid amplification test, regardless of clinical criteria OR epidemiological criteria; or
• 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 > 25) following a SARSCoV-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.

Exclusion Criteria:

• Known pregnancy, breastfeeding, or contemplating pregnancy during the study period.
• Known active acute SARS-CoV-2 infection ≤ 4 weeks from enrollment.
• Known renal failure (eGFR <20ml/1.73 m²).
• Known atrial fibrillation or significant cardiac arrhythmia.
• 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.
• Clinically significant atherosclerotic disease, defined as history of stroke or myocardial infarction or revascularization 6 months prior to enrollment and/or current symptomatic angina.
• Existing uncontrolled hypertension.
• History of significant hypercoagulability disorders.
• Active or recent thrombosis.
• Inability to comply with the protocol.
• Less than 2 weeks since discontinuation/weaning of beta blockers and calcium channel blockers. 
• 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.
• Currently receiving/using intervention from another clinical trial, such as another RECOVER trial.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/25/23. Questions regarding updates should be directed to the study team contact.