The Effect of Amantadine on Post-COVD-19 Fatigue
1 other identifier
interventional
83
1 country
1
Brief Summary
This study aimed to investigate amantadine's safety and its effect on reducing post-COVID-19 fatigue.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2022
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2022
CompletedStudy Start
First participant enrolled
December 26, 2022
CompletedFirst Posted
Study publicly available on registry
December 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2023
CompletedDecember 28, 2022
December 1, 2022
3 days
November 25, 2022
December 26, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Fatigue Severity Scale (FSS)
Comparison of fatigue scale score change before and after treatment with amantadine using FSS Minimum 1 Maximum 7 Higher score means greater fatique severity
2 weaks
Visual Analog Fatigue Scale (VAFS)
Comparison of fatigue scale score change before and after treatment with amantadine using VAFS Minimum 0 Maximum 100 Higher score means greater fatique severity
2 weaks
Study Arms (2)
amantadine
EXPERIMENTALThe group that was treated with amantadine
control
NO INTERVENTIONThe group that was not treated
Interventions
The amantadine group is treated with amantadine capsules 100mg twice a day for two weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shohada Tajrish Hospital
Tehran, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 25, 2022
First Posted
December 28, 2022
Study Start
December 26, 2022
Primary Completion
December 29, 2022
Study Completion
January 10, 2023
Last Updated
December 28, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share