Post-COVID-19 SyndromePhase 4NCT05642923
Post-COVID-19 Chronic Fatigue Syndrome
A Phase 4 study testing Synthetic Vitamin B1 in people with Post-COVID-19 Syndrome and Post-COVID Syndrome, run by ClinAmygate at 1 site in Egypt.
Trial summary
Fatigue is recognized as one of the most commonly presented long-term complaints in individuals previously infected with SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-COVID-19 Syndrome, Post-COVID Syndrome
- What is being tested?
- Synthetic Vitamin B1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jan 2023to 5 Mar 2025
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age . 18
- Male or female
- Post-Covid-19 Fatigue
Who cannot join
- refusal
Trial locations and contacts
1 site in 1 country.
About this study
Fatigue is recognized as one of the most commonly presented long-term complaints in individuals previously infected with SARS-CoV-2.
Read the detailed description
It has become increasingly clear that infected patients have symptoms not only in the acute phase, but also after recovery from the initial infection.
A recent meta-analysis including 4828 patients with post-COVID-19 showed that symptoms and post-acute sequelae of SARS-CoV-2 can persist weeks to months after the infection.
These patients who reported persistent symptoms have been termed "long haulers" or described as having long COVID, post-acute COVID-19, persistent COVID-19 symptoms, post COVID-19 manifestations, long-term COVID-19 effects, post-acute sequelae of COVID-19 (PASC), or post-COVID-19 syndrome.
- Conditions
- Post-COVID-19 Syndrome, Post-COVID Syndrome
- Being tested
- Synthetic Vitamin B1
- 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.
Synthetic Vitamin B1Drug
Synthetic Vitamin B1 400 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Synthetic Vitamin B1 | Active comparator | Synthetic Vitamin B1, 400 mg per day Receives: Drug: Synthetic Vitamin B1 |
| No intervention | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue scale
chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.
Measured: one month
Fatigue scale
chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.
Measured: two month
Fatigue scale
chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.
Measured: three month
Secondary outcomes (1)
Incidence of adverse events
Incidence of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start8 Jan 2023
- Primary completion1 Jun 2024
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- ClinAmygate
- Sponsor type
- University, hospital or other
- Collaborators
- As-Salam Center, Maadi, Cairo, Egypt
- Responsible party
- Principal investigator, Emad R Issak, ClinAmygate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642923
- Sponsor's protocol ID
- PR0012022
- Status last verified
- Mar 2025
- First submitted
- 7 Dec 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon request
Publications
Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015 Jan;65(1):86. doi: 10.1093/occmed/kqu168. No abstract available.
PubMed 25559796Kedor C, Freitag H, Meyer-Arndt L, Wittke K, Hanitsch LG, Zoller T, Steinbeis F, Haffke M, Rudolf G, Heidecker B, Bobbert T, Spranger J, Volk HD, Skurk C, Konietschke F, Paul F, Behrends U, Bellmann-Strobl J, Scheibenbogen C. A prospective observational study of post-COVID-19 chronic fatigue syndrome following the first pandemic wave in Germany and biomarkers associated with symptom severity. Nat Commun. 2022 Aug 30;13(1):5104. doi: 10.1038/s41467-022-32507-6.
PubMed 36042189
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-COVID-19 Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT05642923
- Acronym / sponsor ID
- PR0012022
- Conditions
- Post-COVID-19 Syndrome, Post-COVID Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- ClinAmygateUniversity, hospital or other
- Collaborators
- As-Salam Center, Maadi, Cairo, Egypt
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 8 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.
Fatigue is recognized as one of the most commonly presented long-term complaints in individuals previously infected with SARS-CoV-2.
Detailed description
It has become increasingly clear that infected patients have symptoms not only in the acute phase, but also after recovery from the initial infection.
A recent meta-analysis including 4828 patients with post-COVID-19 showed that symptoms and post-acute sequelae of SARS-CoV-2 can persist weeks to months after the infection.
These patients who reported persistent symptoms have been termed "long haulers" or described as having long COVID, post-acute COVID-19, persistent COVID-19 symptoms, post COVID-19 manifestations, long-term COVID-19 effects, post-acute sequelae of COVID-19 (PASC), or post-COVID-19 syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synthetic Vitamin B1 | Active comparator | Drug: Synthetic Vitamin B1Synthetic Vitamin B1, 400 mg per day |
| No intervention | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age . 18
- Male or female
- Post-Covid-19 Fatigue
Key exclusion criteria (1 listed)
- refusal
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 |
|---|---|---|
| Synthetic Vitamin B1Synthetic Vitamin B1 400 mg per day | Drug | Synthetic Vitamin B1 |
Primary outcome
Fatigue scale
Time frame: one month
chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.
Fatigue scale
Time frame: two month
chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.
Fatigue scale
Time frame: three month
chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.
1 secondary outcome
Incidence of adverse events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Background: PubMed 25559796Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015 Jan;65(1):86. doi: 10.1093/occmed/kqu168. No abstract available.
- Results publication: PubMed 36042189Kedor C, Freitag H, Meyer-Arndt L, Wittke K, Hanitsch LG, Zoller T, Steinbeis F, Haffke M, Rudolf G, Heidecker B, Bobbert T, Spranger J, Volk HD, Skurk C, Konietschke F, Paul F, Behrends U, Bellmann-Strobl J, Scheibenbogen C. A prospective observational study of post-COVID-19 chronic fatigue syndrome following the first pandemic wave in Germany and biomarkers associated with symptom severity. Nat Commun. 2022 Aug 30;13(1):5104. doi: 10.1038/s41467-022-32507-6.
- Individual participant dataSharing planned: Undecided. Upon request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Synthetic Vitamin B1 in people with Post-COVID-19 Syndrome and Post-COVID Syndrome, run by ClinAmygate at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 10 Mar 2025. 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue scale (time frame: one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05642923, which also lists 2 linked publications.
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 10 Mar 2025.