COVID-19 trials registries data warehouse

 Return to trial list

Trial - EUCTR2021-002610-14-DK


Column Value
Trial registration number EUCTR2021-002610-14-DK
Full text link
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-002610-14/DK

First author
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

Aarhus University Hospital, Deparment of Neurology - Atle Vigild Lomstein

Contact
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

atllom@rm.dk

Registration date
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

2021-06-29

Recruitment status
Last imported at : May 18, 2024, 8:14 a.m.
Source : EU Clinical Trials Register

Completed

Study design
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

RCT

Allocation
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

Randomized

Design
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

Crossover

Masking
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

Blind label

Center
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

single-center

Study aim
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

Long covid

Inclusion criteria
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

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 <80% of expected or signs of proximal weakness at physical examination o I1.2 Abnormal decrement on repetitive nerve stimulation in medical history I2. Disease duration of ≥ 3 months I3. Residual symptoms with a FAS I4. Age <65 years I5. Ability to understand the requirements of the trial and provide written, informed consent

Exclusion criteria
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

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.

Number of arms
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

2

Funding
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

Aarhus University Hospital, Department of Neurology

Inclusion age min
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

64

Countries
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

Denmark

Type of patients
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

Patients recovered from covid

Severity scale
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

N/A

Total sample size
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

84

primary outcome
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

• Fatigue (Neuro QoL Fatigue Scale) Decrease in subjective fatigue after treatment. • Tolerability Registration of adverse events

Notes
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

nan

Phase
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

Phase 4

Arms
Last imported at : Sept. 30, 2021, 9:03 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "", "treatment_id": 2338, "treatment_name": "Pyridostigmine+salbutamol", "treatment_type": "Others pharmacological treatment+respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]