Clinical study of the effect and tolerance of Salbutamol and Mestinon as treatments for muscle weakness after COVID-19.

Mestinon and Salbutamol Tolerability and Efficacy as therapy for Post-COVID-19 Myopathy - A randomized, placebo-controlled, rater and subject-blinded, 2x2 crossover study. - MASTER-PCM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002610-14-DK

Enrollment

Registered

2021-06-29

Start date

2021-09-08

Completion date

Unknown

Last updated

2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-COVID-19 Myopathy. MedDRA version: 20.0 Level: HLT Classification code 10062913 Term: Muscle weakness conditions System Organ Class: 100000004859

Interventions

Trade Name: Salbutamol WZF Pharmaceutical Form: Tablet INN or Proposed INN: SALBUTAMOL SULFATE CAS Number: 51022-70-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • I1. Subjective muscular fatigue after confirmed COVID-19, and either/or: o Proximal weakness on examination (MRC score) o I1.1 6 min walk test =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • E1. Evidence of malignancy = 3 years prior to screening, unless deemed completely cured o E1.1 Carcinoma-in-situ allowed o E1.2 Non-melanoma skin cancer allowed o E1.3 Thymoma allowed (if no active treatment is required) • E2. Known muscle disease prior to COVID-19. • E3. Other factor(s) or medical condition(s) that may explain residual symptoms (affective psychiatric conditions, functional, psychosomatic disorders, endocrine disorders, etc.) • E4. Pregnancy or breast-feeding • E5. Treatment with beta-agonists • E6. Uncontrolled diabetes • E7. Ischemic Heart Disease, Cardiac Arrhythmia or Heart Failure (including hypertrophic cardiomyopathy) • E8. Uncontrolled Hypertension (= 160/110) • E9. Known hypersensitivity to any of the study drug components • E10. Treatment with tricyclic antidepressants, monoaminoxidase inhibitors, digoxin, or methylxanthines.

Design outcomes

Primary

Measure	Time frame
Main Objective: Determining tolerability and efficacy of Salbutamol as treatment for Post-COVID-19 myopathy without neuromuscular transmission defect. Determining tolerability and efficacy of Salbutamol and Mestinon as treatments for Post-COVID-19 myopathy with neuromuscular transmission defect. ;Secondary Objective: Not applicable;Primary end point(s): •Fatigue (Neuro QoL Fatigue Scale) Decrease in subjective fatigue after treatment. •Tolerability Registration of adverse events;Timepoint(s) of evaluation of this end point: Tolerability is evaluated at all visits and subjects will report adverse events as they arise. They will be registered and evaluated according to GCP guidelines. All other end points will be registered at screening and at 4 other planned visits. Evaluation after unblinding.	—

Measure

Time frame

Main Objective: Determining tolerability and efficacy of Salbutamol as treatment for Post-COVID-19 myopathy without neuromuscular transmission defect. Determining tolerability and efficacy of Salbutamol and Mestinon as treatments for Post-COVID-19 myopathy with neuromuscular transmission defect. ;Secondary Objective: Not applicable;Primary end point(s): •Fatigue (Neuro QoL Fatigue Scale) Decrease in subjective fatigue after treatment. •Tolerability Registration of adverse events;Timepoint(s) of evaluation of this end point: Tolerability is evaluated at all visits and subjects will report adverse events as they arise. They will be registered and evaluated according to GCP guidelines. All other end points will be registered at screening and at 4 other planned visits. Evaluation after unblinding.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Endpoints • Fatigue Assessment Scale • 6-minute walk test • Five times sit to stand test • FEV1 and FVC • 5 times sit to stand test (5XSST) • Standing Heel Rise test (SHRT) Exploratory Variables • Creatine Kinase;Timepoint(s) of evaluation of this end point: All secondary end points will be registered at screening and at 4 other planned visits. Evaluation after unblinding.	—

Measure

Time frame

Secondary end point(s): Secondary Endpoints • Fatigue Assessment Scale • 6-minute walk test • Five times sit to stand test • FEV1 and FVC • 5 times sit to stand test (5XSST) • Standing Heel Rise test (SHRT) Exploratory Variables • Creatine Kinase;Timepoint(s) of evaluation of this end point: All secondary end points will be registered at screening and at 4 other planned visits. Evaluation after unblinding.

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Countries

Denmark

Contacts

Public ContactAtle Vigild Lomstein

Aarhus University Hospital, Deparment of Neurology

atllom@rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026