Study to Investigate Improvement in Physical Function in SF-36 With Vericiguat Compared With Placebo in Participants With Post-COVID-19 Syndrome

NCT05697640 | Active Not Recruiting Phase 2

• 2 other identifiers: VERI-LONG01EP2201
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the therapeutic value of an approved drug (Vericiguat) in patients with post-COVID-19 syndrome, who suffer from profound tiredness or fatigue, regardless of bed rest.The main questions it aims to answer are: • Does Vericiguat relieve fatigue and/or other symptoms associated with post-COVID-19 syndrome? • What are the side effects of Vericiguat in this patient population; and how common are they? Participants will be asked to participate for approx. 18 weeks. After screening, participants will receive assigned intervention of either 10 weeks of treatment with Vericiguat or matching placebo tablet, followed by 30 day follow-up period. Every participant will undergo trial, cardiovascular safety, and monitoring assessments. The results of this study will provide information on whether Vericiguat can alleviate PCS-related symptoms as well as insights into the pathophysiological processes of PCS, which in turn can help to develop therapies.

Conditions

Post-COVID ME/CFS

Keywords

Post-COVID Syndrome; Long COVID; Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

• Improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)

  The Short Form 36 Health Survey (SF-36) is an established and widely used health-related quality of life measure. The Physical Function (PF) domain asks patients to report limitations on ten mobility activities, such as walking specified distances, carrying groceries, and bathing or dressing. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, i.e., severe disability) to 100 (no health restrictions). An intra-patient change of 10 points in SF-36-PF from baseline to week ten is considered clinically meaningful.

  10 weeks after first IMP intake

Secondary Outcomes (16)

• Difference in responder rate in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36) comparing Vericiguat with placebo

  10 weeks after first IMP intake

• Improvement in other sub-domains of the Short Form 36 Health Survey Questionnaire (SF-36) comparing Vericiguat with placebo

  10 weeks after first IMP intake

• Improvement in fatigue as measured by the Fatigue Severity Score (FSS)

  10 weeks after first IMP intake

• Improvement in severity of muscle pain and headache as measured by the Canadian Consensus Criteria (CCC) symptom score

  10 weeks after first IMP intake

• Improvement in symptoms of myalgic encephalomyelitis (ME)/ chronic fatigue syndrome (CFS) as measured by Canadian Consensus Criteria (CCC) Symptom Score

  10 weeks after first IMP intake

Study Arms (2)

Vericiguat Oral Tablet

ACTIVE COMPARATOR

Tested IMP: Vericiguat (film-coated tablet). Authorization status: Not authorised in this targeted therapeutic indication; Vericiguat is authorized for the dosages that will be administered in this trial for another indication. The tablets used in this trial are no trade product, but a special trial product produced and provided by the marketing authorization holder Bayer. Administration: Once daily (oral). Planned dosage: Three different dosages starting with 2.5 mg for two weeks, followed by 5 mg for two weeks and 10 mg for six weeks. The general IMP titration regimen was investigated and proven to be safe (max. dosages 10 mg/day) in patients with heart failure and reduced ejection fraction (Armstrong et al., 2020).

Drug: Vericiguat Oral Tablet

Placebo Oral Tablet

PLACEBO COMPARATOR

Comparator IMP: Placebo (film-coated tablet). Authorization status: Not authorised. The tablets used in this trial are no trade product, but a special trial product produced and provided by the marketing authorization holder Bayer. Administration: Once daily (oral). Planned dosage: Three different dosages starting with 2.5 mg for two weeks, followed by 5 mg for two weeks and 10 mg for six weeks to have identical conditions to verum.

Drug: Vericiguat Oral Tablet

Interventions

Vericiguat Oral Tablet DRUG

The treatment period includes ten weeks of daily vericiguat or placebo intake (depending on randomization) and a 30-day follow-up period (no vericiguat/placebo intake).

Placebo Oral Tablet; Vericiguat Oral Tablet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female adult who is 18-50 years old
• Confirmed (PCR or serology), non-hospitalized, mild to moderate acute COVID-19 cases according to WHO criteria with proven chronic ED and either: ME/CFS Canadian Consensus Criteria (CCC) with post exertional malaise (PEM) 2 - 14 hours = PCS or ME/CFS CCC criteria with PEM \> 14 hours = PCS/CFS
• Ongoing symptoms of PCS or PCS/CFS for ≥ 6 months
• Bell Score: 30-60
• Evidence for endothelial dysfunction (ED) \[as indicated by reactive hyperemia index (RHI) \< 1.8 and/or ET-1 level \> 90 percentile of healthy age- and gender matched controls or muscle fatigue (below cut-off values of area under the curve reference values for age-matched healthy controls and/or pathological optical coherence tomography angiography (OCTA))\]
• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral/intravaginal/transdermal), or
• progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable), or
• intrauterine device, or
• intrauterine hormone-releasing system, or
• bilateral tubal occlusion, or
• vasectomised partner, or
• heterosexual abstinence.

You may not qualify if:

• Pre-COVID history of chronic fatigue syndrome or other fatigue syndromes that are due to associated diseases (e.g., cancer, autoimmune diseases \[patients with a preexisting Hashimoto thyroiditis and/or fibromyalgia without fatigue syndromes can be included\])
• Concomitant use of Vericiguat due to other diseases
• Contraindications against IMP
• Concurrent or anticipated concomitant use of PDE-5 inhibitors such as vardenafil, tadalafil, and sildenafil, nitrates, or sGC-stimulators
• Use of other sGC stimulators, e.g., riociguat
• Hypersensitivity to the active substance or any of the other ingredients
• Systolic blood pressure: \< 100 mmHg at screening
• Known SARS-CoV-2 infection-related organ damage/comorbidity
• Severe renal or hepatic insufficiency
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Bayer: collaborator

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

• Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, Lam CSP, Ponikowski P, Voors AA, Jia G, McNulty SE, Patel MJ, Roessig L, Koglin J, O'Connor CM; VICTORIA Study Group. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2020 May 14;382(20):1883-1893. doi: 10.1056/NEJMoa1915928. Epub 2020 Mar 28.

  PMID: 32222134 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue Syndrome, Chronic

Interventions

vericiguat

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Judith Bellmann-Strobl, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician

Model Details: Two-arm parallel-group, randomized, placebo-controlled, double-blind, single-centre clinical trial in participants with post-COVID syndrome with and without ME/CFS.

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: January 26, 2023
• Study Start: June 22, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

DE (1)