The Effect of Amantadine on Post-COVD-19 Fatigue | NCT05667077

Studies
The Effect of Amantadine on Post-COVD-19 Fatigue

NCT05667077

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Unknown status

Last Update Posted

Dec 28, 2022Actual

Enrollment

83Estimated

Phase

Phase 2

Conditions

Post-COVID-19 Syndrome

Interventions

Amantadine

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 26, 2022Estimated

Primary Completion Date

Dec 29, 2022Estimated

Completion Date

Jan 10, 2023Estimated

First Submitted Date

Nov 25, 2022

First Submission Date that Met QC Criteria

Dec 26, 2022

First Posted Date

Dec 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2022

Last Update Posted Date

Dec 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

83Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
amantadine	Experimental	The group that was treated with amantadine	Drug: Amantadine
control	No Intervention	The group that was not treated

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amantadine	Drug	The amantadine group is treated with amantadine capsules 100mg twice a day for two weeks	amantadine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000094024	Post-Acute COVID-19 Syndrome

Ancestor Terms

ID	Term
D000086382	COVID-19
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000547	Amantadine

Ancestor Terms

ID	Term
D000218	Adamantane
D001952	Bridged-Ring Compounds
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided