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The Effect of Amantadine on Post-COVD-19 Fatigue

Primary Purpose

Post-COVID-19 Syndrome

Status
Not yet recruiting
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Amantadine
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-COVID-19 Syndrome

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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: 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

Sites / Locations

  • Shohada Tajrish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

amantadine

control

Arm Description

The group that was treated with amantadine

The group that was not treated

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
November 25, 2022
Last Updated
December 26, 2022
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05667077
Brief Title
The Effect of Amantadine on Post-COVD-19 Fatigue
Official Title
The Effect of Amantadine on Post-COVD-19 Fatigue: a Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 26, 2022 (Anticipated)
Primary Completion Date
December 29, 2022 (Anticipated)
Study Completion Date
January 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aimed to investigate amantadine's safety and its effect on reducing post-COVID-19 fatigue.
Detailed Description
Background The 2019 coronavirus disease has severely affected the health of the general public. Even after recovery, this disease can cause problems, including chronic fatigue, which the patient can suffer from for years and cause permanent disability for a number of patients. Despite the fact that fatigue due to COVID-19 has affected many patients, not many studies have been done in the field of effective treatment for this problem. In this study, the investigators studied the effect of amantadine on the fatigue of COVID-19 patients. Method In this clinical trial study, 83 patients were randomly included in the study from the patients referred to the internal clinic of Shohada Tajrish Hospital in Tehran, and they were initially evaluated by VAFS and FSS questionnaires. 17 patients were initially excluded due to having at least one exclusion criterion. And 66 patients were randomly divided between two groups using amantadine and the control group. The amantadine group was treated with amantadine capsules 100 mg BD for 2 weeks and after 2 weeks again for both The group questionnaire was completed, and the data was analyzed by SPSS software version 26.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID-19 Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
amantadine
Arm Type
Experimental
Arm Description
The group that was treated with amantadine
Arm Title
control
Arm Type
No Intervention
Arm Description
The group that was not treated
Intervention Type
Drug
Intervention Name(s)
Amantadine
Intervention Description
The amantadine group is treated with amantadine capsules 100mg twice a day for two weeks
Primary Outcome Measure Information:
Title
Fatigue Severity Scale (FSS)
Description
Comparison of fatigue scale score change before and after treatment with amantadine using FSS Minimum 1 Maximum 7 Higher score means greater fatique severity
Time Frame
2 weaks
Title
Visual Analog Fatigue Scale (VAFS)
Description
Comparison of fatigue scale score change before and after treatment with amantadine using VAFS Minimum 0 Maximum 100 Higher score means greater fatique severity
Time Frame
2 weaks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Facility Information:
Facility Name
Shohada Tajrish Hospital
City
Tehran
Country
Iran, Islamic Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Amini harandi, professor assistant
Phone
00989126026214
Email
ali.amini.harandi@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Amantadine on Post-COVD-19 Fatigue

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