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NCT05481177: COVIVA

Ivabradine for Long-Term Effects of COVID-19 With POTS Cohort

Status unknown Phase 4 Last updated 29 November 2023
What this trial tests

Phase 4 trial testing Ivabradine in Long Haul COVID in 250 participants. Status unknown.

Timeline
14 June 2023
Primary endpoint
1 September 2024
1 September 2024

Quick facts

Lead sponsorUniformed Services University of the Health Sciences
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment250
Start date14 June 2023
Primary completion1 September 2024
Estimated completion1 September 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Uniformed Services University of the Health Sciences

Who can join

Adults 18 to 80, any sex, with Long Haul COVID or Postural Orthostatic Tachycardia Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is three-fold. The primary aim is to identify the proportion of Long-Haul COVID (LHC) and non-LHC volunteers with relevant symptoms actually have postural orthostatic tachycardia syndrome (POTS). The second is to determine benefit of ivabradine treatment. Ivabradine is a drug approved to treat tachycardia in persons with heart failure. The third is to characterize risk factors and outcomes among volunteers with and without LHC. This will include comparison with COVID-19-positive individuals who did not develop long-COVID symptoms. The study will improve basic and applied knowledge of LHC and its associated cardiovascular and autonomic consequences. Cellular and molecular characterization of LHC and non-LHC participants will be performed with a nested clinical trial for Ivabradine responsiveness on reduction of tachycardia. It is hoped that a greater understanding of LHC, and related autonomic dysfunction in particular will help to identify treatment paradigms and therapeutic targets for improving recovery and enhancing health for those affected.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The long-term health outcomes, pathophysiological mechanisms and multidisciplinary management of long COVID.
    Li J, Zhou Y, Ma J, Zhang Q, et al · · 2023 · cited 91× · PMID 37907497 · DOI 10.1038/s41392-023-01640-z
  2. Therapeutic trials for long COVID-19: A call to action from the interventions taskforce of the RECOVER initiative.
    Bonilla H, Peluso MJ, Rodgers K, Aberg JA, et al · · 2023 · cited 72× · PMID 36969241 · DOI 10.3389/fimmu.2023.1129459
  3. Long COVID: Complications, Underlying Mechanisms, and Treatment Strategies.
    Zadeh FH, Wilson DR, Agrawal DK. · · 2023 · cited 36× · PMID 37388279 · DOI 10.26502/ami.93650103
  4. Cardiovascular disease and covid-19: A systematic review.
    Krishna BA, Metaxaki M, Sithole N, Landín P, et al · · 2024 · cited 17× · PMID 39189008 · DOI 10.1016/j.ijcha.2024.101482
  5. Postural Orthostatic Tachycardia Syndrome in COVID-19: A Contemporary Review of Mechanisms, Clinical Course and Management.
    Narasimhan B, Calambur A, Moras E, Wu L, et al · · 2023 · cited 14× · PMID 37204997 · DOI 10.2147/vhrm.s380270
  6. The current landscape of long COVID clinical trials: NIH's RECOVER to Stanford Medicine's STOP-PASC initiative.
    Chakraborty C, Bhattacharya M. · · 2023 · cited 7× · PMID 37680987 · DOI 10.1016/j.omtn.2023.08.016
  7. Evidence for targeting autonomic dysfunction in systemic sclerosis: A scoping review.
    Cuevas S, Mayer E, Hughes M, Adler BL, et al · · 2025 · cited 6× · PMID 39790996 · DOI 10.1177/23971983241308050
  8. Comparative cohort study of post-acute COVID-19 infection with a nested, randomized controlled trial of ivabradine for those with postural orthostatic tachycardia syndrome (the COVIVA study).
    Saunders D, Arnold TB, Lavender JM, Bi D, et al · · 2025 · cited 2× · PMID 40692561 · DOI 10.3389/fneur.2025.1550636

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