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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05667077 |
|
Full text link
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
None |
|
Registration date
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
2022-12-28 |
|
Recruitment status
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Long covid |
|
Inclusion criteria
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
inclusion criteria: clinical diagnosis of covid-19 clinical evidence of fatigue despite the passage of 30 to 60 days from the onset --of the symptoms of covid-19 willingness and informed consent to participate in the study |
|
Exclusion criteria
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
the recurrence of covid-19 in the form of re-infection history of psychiatric diseases psychotic disorders (in the form of hallucinations and delusions) anxiety disorders and major depression substance abuse in the last four months taking antidepressants during the last six weeks corticosteroids consumption during the last six weeks taking psychostimulant drugs an unstable medical condition cognitive disorders and confusion withdrawal from participating in the study history of rheumatological disease getting cancer and malignancy advanced chronic diseases (heart, liver, kidney, etc.) edema of organs hypertension (untreated) hypogonadism (untreated) hypothyroidism (untreated) anemia (untreated) pregnancy and breastfeeding nausea and vomiting when starting to take amantadine convulsions dyspnea post-covid-19 encephalopathy |
|
Number of arms
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Shahid Beheshti University of Medical Sciences |
|
Inclusion age min
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
20 |
|
Inclusion age max
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
50 |
|
Countries
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Iran;Islamic Republic of |
|
Type of patients
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Patients recovered from covid |
|
Severity scale
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
83 |
|
primary outcome
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Fatigue Severity Scale (FSS);Visual Analog Fatigue Scale (VAFS) |
|
Notes
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 74, "treatment_name": "Amantadine", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |