The Effect of Amantadine on Post-COVD-19 Fatigue

The Effect of Amantadine on Post-COVD-19 Fatigue: a Clinical Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Post-COVID-19 Syndrome
• Intervention / Treatment: Drug: Amantadine

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 Type: Interventional
• Enrollment (Anticipated): 83
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Shohada Tajrish Hospital
    • Contact: Ali Amini harandi, professor assistant; Phone Number: 00989126026214; Email: ali.amini.harandi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): December 26, 2022
• Primary Completion (Anticipated): December 29, 2022
• Study Completion (Anticipated): January 10, 2023

Study Registration Dates

• First Submitted: November 25, 2022
• First Submitted That Met QC Criteria: December 26, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 26, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Amantadine
• Other Study ID Numbers: IR.SBMU.MSP.REC.1400.555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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