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

NCT05096884 | Terminated Early Phase 1 Results FDA Drug

• 1 other identifier: Pro2021-1100
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tachycardia; Dyspnea; COVID-19

Keywords

COVID-19; Post-COVID; Long-COVID; Tachycardia; Shortness of breath; Post-Acute Sequelae of COVID-19 (PASC)

Outcome Measures

Primary Outcomes (2)

• Change in 6 Minute Walk Test at the End of Treatment Period

  To assess the reduction of symptoms in patients with PASC Dyspnea on Exertion (DOE) and associated tachycardia when treated with beta blockers as captured in patients walk test. Walk test will be performed at day 1 (baseline) and at 2-4 weeks post treatment completion which consists of 8 weeks metoprolol succinate (approximately 12 weeks from baseline).

  12 weeks from baseline walk test

• Change in Zva Measurement at the End of Treatment Period

  To assess the reduction of symptoms in patients with PASC Dyspnea on Exertion (DOE) and associated tachycardia when treated with beta blockers as captured in Zva measurement calculated from patient's TTE (transthoracic echocardiogram). TTE (and Zva) will be performed at day 1 (baseline) and at 2-4 weeks post treatment completion which consists of 8 weeks metoprolol succinate (approximately 12 weeks from baseline).

  12 weeks from baseline transthoracic echocardiogram (TTE).

Secondary Outcomes (1)

• Change in Minnesota Living With Heart Failure Score at the End of Treatment Period

  12 weeks from baseline

Study Arms (1)

Study arm - Metoprolol Succinate.

EXPERIMENTAL

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.

Drug: Metoprolol Succinate

Interventions

Metoprolol Succinate DRUG

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.

Study arm - Metoprolol Succinate.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack Univeristy Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (4)

• Page RL, Joglar JA, Caldwell MA, Calkins H, Conti JB, Deal BJ, Estes NA 3rd, Field ME, Goldberger ZD, Hammill SC, Indik JH, Lindsay BD, Olshansky B, Russo AM, Shen WK, Tracy CM, Al-Khatib SM; Evidence Review Committee Chairdouble dagger. 2015 ACC/AHA/HRS Guideline for the Management of Adult Patients With Supraventricular Tachycardia: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. 2016 Apr 5;133(14):e506-74. doi: 10.1161/CIR.0000000000000311. Epub 2015 Sep 23. No abstract available.

  PMID: 26399663 BACKGROUND

• Brugada J, Katritsis DG, Arbelo E, Arribas F, Bax JJ, Blomstrom-Lundqvist C, Calkins H, Corrado D, Deftereos SG, Diller GP, Gomez-Doblas JJ, Gorenek B, Grace A, Ho SY, Kaski JC, Kuck KH, Lambiase PD, Sacher F, Sarquella-Brugada G, Suwalski P, Zaza A; ESC Scientific Document Group. 2019 ESC Guidelines for the management of patients with supraventricular tachycardiaThe Task Force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC). Eur Heart J. 2020 Feb 1;41(5):655-720. doi: 10.1093/eurheartj/ehz467. No abstract available.

  PMID: 31504425 BACKGROUND

• Deng X, Zhang Y, Liao Y, Du J. Efficacy of beta-Blockers on Postural Tachycardia Syndrome in Children and Adolescents: A Systematic Review and Meta-Analysis. Front Pediatr. 2019 Nov 7;7:460. doi: 10.3389/fped.2019.00460. eCollection 2019.

  PMID: 31788462 BACKGROUND

• Raj SR, Black BK, Biaggioni I, Paranjape SY, Ramirez M, Dupont WD, Robertson D. Propranolol decreases tachycardia and improves symptoms in the postural tachycardia syndrome: less is more. Circulation. 2009 Sep 1;120(9):725-34. doi: 10.1161/CIRCULATIONAHA.108.846501. Epub 2009 Aug 17.

  PMID: 19687359 BACKGROUND

MeSH Terms

Conditions

Tachycardia; Dyspnea; COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Results Point of Contact

• Title: Jana Tancredi
• Organization: Hackensack Meridian Health

Jana.Tancredi@hmhn.org

5519962353

Study Officials

• David Landers, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: October 27, 2021
• Study Start: March 23, 2022
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: December 3, 2024
• Results First Posted: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)