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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05642923
Other study ID # PR0012022
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 8, 2023
Est. completion date December 8, 2023

Study information

Verified date September 2023
Source ClinAmygate
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 480
Est. completion date December 8, 2023
Est. primary completion date October 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age . 18 - Male or female - Post-Covid-19 Fatigue Exclusion Criteria: - refusal

Study Design


Intervention

Drug:
Synthetic Vitamin B1
Synthetic Vitamin B1 400 mg per day

Locations

Country Name City State
Egypt Asalam Maadi Cairo

Sponsors (2)

Lead Sponsor Collaborator
ClinAmygate As-Salam Center, Maadi, Cairo, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Fatigue scale chalder fatigue scale one month
Primary Fatigue scale chalder fatigue scale two month
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