The Effect of Amantadine on Post-COVD-19 Fatigue

Post-COVID-19 Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05667077
• Other study ID #: IR.SBMU.MSP.REC.1400.555
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 26, 2022
• Est. completion date: January 10, 2023

Study information

• Verified date: December 2022
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 83
• Est. completion date: January 10, 2023
• Est. primary completion date: December 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Post-COVID-19 Syndrome

Intervention

Drug:
• Amantadine
The amantadine group is treated with amantadine capsules 100mg twice a day for two weeks

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shohada Tajrish Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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