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The Effect of Amantadine on Post-COVD-19 Fatigue

Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05667077
Collaborator
(none)
83
Enrollment
1
Location
2
Arms
15
Anticipated Duration (Days)
168.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
83 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Amantadine on Post-COVD-19 Fatigue: a Clinical Trial
Anticipated Study Start Date :
Dec 26, 2022
Anticipated Primary Completion Date :
Dec 29, 2022
Anticipated Study Completion Date :
Jan 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: amantadine

The group that was treated with amantadine

Drug: Amantadine
The amantadine group is treated with amantadine capsules 100mg twice a day for two weeks
No Intervention: control

The group that was not treated

Outcome Measures

Primary Outcome Measures

  1. Fatigue Severity Scale (FSS) [2 weaks]

    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. Visual Analog Fatigue Scale (VAFS) [2 weaks]

    Comparison of fatigue scale score change before and after treatment with amantadine using VAFS Minimum 0 Maximum 100 Higher score means greater fatique severity

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shohada Tajrish Hospital Tehran Iran, Islamic Republic of

Sponsors and Collaborators

  • Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ali Amini Harandi, Assistant Professor, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT05667077
Other Study ID Numbers:
  • IR.SBMU.MSP.REC.1400.555
First Posted:
Dec 28, 2022
Last Update Posted:
Dec 28, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Fatigue
Amantadine

Study Results

No Results Posted as of Dec 28, 2022