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

Who is this study for? Patients with Tachycardia, Dyspnea, COVID-19
What treatments are being studied? Metoprolol Succinate
Status: Terminated
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Hackensack Univeristy Medical Center
Hackensack
Time Frame
Start Date: 2022-03-23
Completion Date: 2023-09-12
Participants
Target number of participants: 14
Treatments
Experimental: Study arm - Metoprolol Succinate.
The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily.
Related Therapeutic Areas
Sponsors
Leads: Hackensack Meridian Health

This content was sourced from clinicaltrials.gov

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