Post-COVID-19 Chronic Fatigue Syndrome

NCT ID: NCT05642923

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

528 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-08

Study Completion Date

2025-03-05

Brief Summary

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Fatigue is recognized as one of the most commonly presented long-term complaints in individuals previously infected with SARS-CoV-2.

Detailed Description

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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

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Post-COVID-19 Syndrome Post-COVID Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Synthetic Vitamin B1

Synthetic Vitamin B1, 400 mg per day

Group Type ACTIVE_COMPARATOR

Synthetic Vitamin B1

Intervention Type DRUG

Synthetic Vitamin B1 400 mg per day

No intervention

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Synthetic Vitamin B1

Synthetic Vitamin B1 400 mg per day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age . 18
* Male or female
* Post-Covid-19 Fatigue

Exclusion Criteria

* refusal
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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As-Salam Center, Maadi, Cairo, Egypt

UNKNOWN

Sponsor Role collaborator

ClinAmygate

OTHER

Sponsor Role lead

Responsible Party

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Emad R Issak

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asalam

Maadi, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

References

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Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015 Jan;65(1):86. doi: 10.1093/occmed/kqu168. No abstract available.

Reference Type BACKGROUND
PMID: 25559796 (View on PubMed)

Kedor 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.

Reference Type RESULT
PMID: 36042189 (View on PubMed)

Other Identifiers

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PR0012022

Identifier Type: -

Identifier Source: org_study_id

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