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The Effect of Amantadine on Post-COVD-19 Fatigue

NCT ID: NCT05667077

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-26

Study Completion Date

2023-01-10

Brief Summary

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This study aimed to investigate amantadine's safety and its effect on reducing post-COVID-19 fatigue.

Detailed Description

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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.

Conditions

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Post-COVID-19 Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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amantadine

The group that was treated with amantadine

Group Type EXPERIMENTAL

Amantadine

Intervention Type DRUG

The amantadine group is treated with amantadine capsules 100mg twice a day for two weeks

control

The group that was not treated

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Amantadine

The amantadine group is treated with amantadine capsules 100mg twice a day for two weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ali Amini Harandi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shohada Tajrish Hospital

Tehran, , Iran

Site Status

Countries

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Iran

Facility Contacts

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Ali Amini harandi, professor assistant

Role: primary

Other Identifiers

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IR.SBMU.MSP.REC.1400.555

Identifier Type: -

Identifier Source: org_study_id