Post-COVID-19 Chronic Fatigue Syndrome

• Sponsor: ClinAmygate (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05642923
• Collaborator: As-Salam Center, Maadi, Cairo, Egypt (Other)
• Enrollment: 480
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 96.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post-COVID-19 Syndrome; Post-COVID Syndrome	Drug: Synthetic Vitamin B1	Phase 4

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

• Study Type: Interventional
• Anticipated Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Post-COVID-19 Chronic Fatigue Syndrome
• Anticipated Study Start Date: Dec 8, 2022
• Anticipated Primary Completion Date: Apr 8, 2023
• Anticipated Study Completion Date: May 8, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Synthetic Vitamin B1 Synthetic Vitamin B1, 400 mg per day	Drug: Synthetic Vitamin B1; Synthetic Vitamin B1 400 mg per day
No Intervention: No intervention No intervention

Outcome Measures

Primary Outcome Measures

1. Fatigue scale [one month]

   chalder fatigue scale

2. Fatigue scale [two month]

   chalder fatigue scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age . 18

• Male or female

• Post-Covid-19 Fatigue

Exclusion Criteria:

• refusal

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asalam	Maadi	Cairo	Egypt	11433

Sponsors and Collaborators

• ClinAmygate
• As-Salam Center, Maadi, Cairo, Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Emad R Issak, Dr, ClinAmygate
• ClinicalTrials.gov Identifier: NCT05642923
• Other Study ID Numbers: PR0012022
• First Posted: Dec 8, 2022
• Last Update Posted: Dec 8, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Fatigue Syndrome, Chronic; Syndrome; Thiamine

Study Results

No Results Posted as of Dec 8, 2022