Post-Acute Sequelae of Coronavirus-19 (COVID-19) With Dyspnea on Exertion And Associated TaChycardia TrEatment Study

Stopped early · Early Phase 1

Conditions studied: Tachycardia, Dyspnea, COVID-19

In brief

Most patients with acute COVID-19 (Coronavirus 19) recover within weeks, however a significant number of individuals will develop the post-acute COVID 19 syndrome (PASC). As of July 2021, the post COVID syndrome qualifies as a disability under the Americans with Disabilities Act. The symptoms which comprise this condition are highly variable and often extraordinarily debilitating. They may be distinct from the initial presentation or may mimic those which defined the initial infection. The post COVID syndrome can be diagnosed when symptoms persist longer than 3 months and may extend to beyond one year. There are risks for permanent levels of disability. Patients who seemingly did not have active COVID-19 symptoms in the days following infectious exposure may also develop post Covid syndromes. These syndromes are considered to constitute a distinct clinical entity which has of yet no clearly defined pathogenic mechanism or validated treatment algorithms. International investigative efforts are now underway to determine who might develop the post COVID syndrome, it's long term consequences and how best to treat its many problematic symptoms.

Key facts

Study ID

NCT05096884

Run by

Hackensack Meridian Health

People needed

14

Starts

2022-03-23

Expected to finish

2023-09-12

Last updated by the study team

2024-12-03

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject should be between the ages of 18 and 40 with DOE (dyspnea on exertion) for 3 - 12 months
• Subjects recovered from acute, polymerase chain reaction (PCR) positive, COVID-19 infection
• Recovery from COVID-19 will be defined as substantial improvement in or essential resolution of initial clinical symptoms
• Demonstration of tachycardia and/or dyspnea with minimal activity (subjectively different than pre-COVID 19 infection state)
• Abnormal HUTT (heads up tilt test)
• Normal chest x-ray
• Left ventricular ejection fraction (LVEF) >50% by transthoracic echocardiography
• Zva >3.5 as calculated from TTE (transthoracic echocardiogram).
• Hemoglobin/Hematocrit within normal laboratory standards
• Thyroid-stimulating hormone (TSH) within normal laboratory standards

You may not qualify if…

• Active pregnancy (negative pregnancy test is the standard of care prior to HUTT)
• Demonstrate a primary cause of appropriate DOE and sinus tachycardia
• Fevers/infection
• Hypovolemia
• Anemia
• Hyperthyroidism
• Alcohol/drug/medication withdrawal
• Currently taking beta blocker medications
• Currently being treated for pre-existing neurally mediated hypotension/syncope or known dysautonomia.
• Medical history of chronic lung disease or reactive airway syndrome.

Where it is running

• Hackensack Univeristy Medical Center — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.