Post-Acute COVID-19 Syndrome
Conditions
Interventions
This phase 2/3 randomized, closed, single-blind study will evaluate the effectiveness of creatine supplementation in the treatment of long-term Covid-related fatigue. The indicated dosage corresponds
Group 2 - Physical exercise + 18g/day creatine supplementation: 20 participants
Group 3 - Physical exercise + 6g/day maltodextrin supplementation (placebo): 20 participants.
For phase 3, the amount of supplementation (6g or 18g) will be determined and calculated the number of par
Group 2: Physical exercise + 6g/day maltodextrin supplementation (placebo).
Sponsors
Hospital das Clínicas da Faculdade de Medicina de Botucatu - HCFMB
Universidade Estadual Paulista "Júlio de Mesquita Filho", Faculdade de Medicina de Botucatu
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult men or women with a prior diagnosis of COVID-19 confirmed by documented testing. Presence of fatigue for more than 12 weeks after acute Covid-19 infection. Clinical stability. Negative pregnancy test for women of childbearing age. Understand, sign and date the written voluntary TCLE at the visit before any protocol-specific procedure. Be able and willing to comply with study visits and study procedures
Exclusion criteria
Exclusion criteria: Hospitalized individuals. Pre-existing, severe, uncontrolled organ failure which precludes participation in the study at the discretion of the investigators. Patients with pulmonary sequelae identified on chest CT scans performed prior to the baseline assessment. Pregnant or lactating women. Use of any investigational or unregistered product within the 3-month period or the 5-half-life period before the baseline period, whichever is longer. Any condition that, in the opinion of the investigators, could compromise the participant's safety or adherence to the study protocol, which includes the inability to perform physical exercise. Psychic disorders that prevent understanding of the proposed procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to observe a reduction in the fatigue score (< 4 points on the Piper scale) after 28±3 days of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| The expectation is to observe an improvement in physical capacity (> 4% in the six-minute walk test), muscle strength (handgrip strength equal to or greater than 80% of predicted), body composition (any reduction in adipose tissue and an increase in lean mass compared to baseline values), and systemic inflammation (any reduction in inflammatory markers from baseline values) after 28±3 days of intervention. | — |
Countries
Brazil
Contacts
Public ContactRobson Prudente
Hospital das Clínicas da Faculdade de Medicina de Botucatu - HCFMB
Outcome results
None listed