Use of 1-MNA to Improve Exercise Tolerance and Fatigue in Patients After COVID-19

Study Overview
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Brief Summary
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Coronavirus disease 2019 (COVID-19) is a serious respiratory disease that results from infection with a newly discovered coronavirus (SARS-COV-2). Unfortunately, COVID-19 is not only a short-term infection but that patients (pts) recovering from SARS-COV2 infection complain of persisting symptoms including: fatigue, diffuse myalgia and weakness, which may lead to chronic fatigue syndrome. There is currently no evidence that nutritional supplements and/or physical exercise can assist in the recovery of pts with chronic fatigue syndrome. 1-Methylnicotinamide (1-MNA) is an endogenic substance that is produced in the liver when nicotinic acid is metabolized. 1-MNA demonstrates anti-inflammatory and anti-thrombotic properties. Therefore, we investigated whether 1-MNA supplements could improve exercise tolerance and decrease fatigue among patients recovering from SARS-COV-2.

Detailed Description
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The study population was composed of pts after COVID-19, expressing subjective feelings of limited tolerance to exercise. The selected pts were randomized into two groups: GrM0 - without supplementation; GrM1 - with 1-MNA supplementation. At the beginning of the study (Phase 0), in both groups, a 6-minute walk test (6MWT) was carried out and fatigue assessment with Fatigue Severity Scale (FSS) was performed. After 1 month (Phase 1), a fol-low up FSS and 6MWT once more were performed in both groups.

Official Title
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Use of 1-MNA to Improve Exercise Tolerance and Fatigue in Patients After COVID-19

Conditions
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Covid19, Fatigue Syndrome, Chronic

Intervention / Treatment
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* Dietary Supplement: 1-MNA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients after COVID-19 Patients expressing subjective feelings of limited tolerance to exercise and above 50% greater fatigue compared to their pre-COVID-19 levels (symptoms must have continued for at least four weeks since the last symptoms of infection) Exclusion Criteria: Patients with cardiological complications Patients with pulmonological complications Patients with Chronic Obstructive Pulmonary Disease and/or asthma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GrM0<br>GrM0 - without supplementation | |
| GrM1<br>GrM1 - with 1-MNA supplementation | Dietary Supplement: 1-MNA<br>* 1-MNA supplementation<br>* Other names: 1-Methylnicotinamide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6MWT | 6-Minute Walk Test - Walking distance in meters in 6-minute walk test | 1 Month | 
| FSS | Fatigue Severity Scale - a self-administered questionnaire for assessing the severity of fatigue in different situations over the past week. Each item is rated on a scale from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement. | 1 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, Chronic Fatigue Syndrome, 1-MNA, 1-Methylnicotinamide, post-COVID syndrome