NCT05642923

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
528

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 8, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2025

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

December 7, 2022

Last Update Submit

March 5, 2025

Conditions

Post-COVID-19 SyndromePost-COVID Syndrome

Outcome Measures

Primary Outcomes (3)

  • Fatigue scale

    chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.

    one month

  • Fatigue scale

    chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.

    two month

  • Fatigue scale

    chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.

    three month

Secondary Outcomes (1)

  • Incidence of adverse events

    6 months

Study Arms (2)

Synthetic Vitamin B1

ACTIVE COMPARATOR

Synthetic Vitamin B1, 400 mg per day

Drug: Synthetic Vitamin B1

No intervention

NO INTERVENTION

No intervention

Interventions

Synthetic Vitamin B1DRUG

Synthetic Vitamin B1 400 mg per day

Synthetic Vitamin B1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asalam

Maadi, Cairo Governorate, 11433, Egypt

Location

Related 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.

    PMID: 25559796BACKGROUND

  • 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.

    PMID: 36042189RESULT

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 8, 2022

Study Start

January 8, 2023

Primary Completion

June 1, 2024

Study Completion

March 5, 2025

Last Updated

March 10, 2025

Record last verified: 2025-03

Locations

EG(1)