Back to resultsPost-COVID-19 Chronic Fatigue Syndrome
Primary Purpose
Post-COVID-19 Syndrome, Post-COVID Syndrome
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Synthetic Vitamin B1
Sponsored by
About this trial
This is an interventional treatment trial for Post-COVID-19 Syndrome
Eligibility Criteria
Inclusion Criteria: Age . 18 Male or female Post-Covid-19 Fatigue Exclusion Criteria: refusal
Sites / Locations
- AsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Synthetic Vitamin B1
No intervention
Arm Description
Synthetic Vitamin B1, 400 mg per day
No intervention
Outcomes
Primary Outcome Measures
Fatigue scale
chalder fatigue scale
Fatigue scale
chalder fatigue scale
Secondary Outcome Measures
Full Information
NCT ID
NCT05642923
First Posted
December 7, 2022
Last Updated
September 4, 2023
Sponsor
ClinAmygate
Collaborators
As-Salam Center, Maadi, Cairo, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT05642923
Brief Title
Post-COVID-19 Chronic Fatigue Syndrome
Official Title
Post-COVID-19 Chronic Fatigue Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2023 (Actual)
Primary Completion Date
October 8, 2023 (Anticipated)
Study Completion Date
December 8, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ClinAmygate
Collaborators
As-Salam Center, Maadi, Cairo, Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID-19 Syndrome, Post-COVID Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Synthetic Vitamin B1
Arm Type
Active Comparator
Arm Description
Synthetic Vitamin B1, 400 mg per day
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Synthetic Vitamin B1
Intervention Description
Synthetic Vitamin B1 400 mg per day
Primary Outcome Measure Information:
Title
Fatigue scale
Description
chalder fatigue scale
Time Frame
one month
Title
Fatigue scale
Description
chalder fatigue scale
Time Frame
two month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age . 18
Male or female
Post-Covid-19 Fatigue
Exclusion Criteria:
refusal
Facility Information:
Facility Name
Asalam
City
Maadi
State/Province
Cairo
ZIP/Postal Code
11433
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emad R Issak, MD
Phone
01272228989
Email
dr.emad.r.h.issak@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Upon request
Citations:
PubMed Identifier
25559796
Citation
Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015 Jan;65(1):86. doi: 10.1093/occmed/kqu168. No abstract available.
Results Reference
background
PubMed Identifier
36042189
Citation
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. Erratum In: Nat Commun. 2022 Oct 12;13(1):6009.
Results Reference
result
Learn more about this trial
Post-COVID-19 Chronic Fatigue Syndrome
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