Post-COVID-19 SyndromePhase 2NCT05667077
The Effect of Amantadine on Post-COVD-19 Fatigue
A Phase 2 study testing Amantadine in people with Post-COVID-19 Syndrome, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
This study aimed to investigate amantadine's safety and its effect on reducing post-COVID-19 fatigue. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Post-COVID-19 Syndrome
- What is being tested?
- Amantadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteIran
- Study dates
- 26 Dec 2022to 10 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shohada Tajrish Hospital
Tehran
Ali Amini harandi, professor assistant, 00989126026214, ali.amini.harandi@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-COVID-19 Syndrome
- Being tested
- Amantadine
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmantadineDrug
The amantadine group is treated with amantadine capsules 100mg twice a day for two weeks
| Study group | Role | What they receive |
|---|---|---|
| amantadine | Experimental | The group that was treated with amantadine Receives: Drug: Amantadine |
| control | No intervention | The group that was not treated |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 weaks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start26 Dec 2022 (estimated)
- Primary completion29 Dec 2022 (estimated)
- Study completion10 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Amini Harandi, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667077
- Sponsor's protocol ID
- IR.SBMU.MSP.REC.1400.555
- Status last verified
- Dec 2022
- First submitted
- 25 Nov 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Amantadine on Post-COVD-19 Fatigue: a Clinical Trial
- ClinicalTrials.gov ID
- NCT05667077
- Acronym / sponsor ID
- IR.SBMU.MSP.REC.1400.555
- Conditions
- Post-COVID-19 Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 26 Dec 2022 (estimated)
- Primary completion
- 29 Dec 2022 (estimated)
- Study completion
- 10 Jan 2023 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amantadine | Experimental | Drug: AmantadineThe group that was treated with amantadine |
| control | No intervention | –The group that was not treated |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmantadineThe amantadine group is treated with amantadine capsules 100mg twice a day for two weeks | Drug | amantadine |
Primary outcome
Fatigue Severity Scale (FSS)
Time frame: 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
Visual Analog Fatigue Scale (VAFS)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Post-COVID-19 Syndrome
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amantadine in people with Post-COVID-19 Syndrome, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (FSS) (time frame: 2 weaks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.