Covid19NCT04784546
Evaluation of Muscle Strength, Functional Independence, Myalgia, Fatigue and Dyspnea in COVID-19 Infection
An observational study of Covid19, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Coronavirus disease 2019 (COVID-19) is a serious, acute infectious disease caused by Serious Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). COVID-19 can manifest itself in a wide variety of clinical scenarios. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Covid19
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 6 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study cohort will consist of patients receiving inpatient treatment for mild, moderate and severe COVID-19 infection in a university hospital. Every subject meeting the criteria of inclusion is going to be included into the study via consecutive participant sampling method.
Who may be able to join
- 18-85 years of age
- SARS-CoV-2 infection to be confirmed by polymerase chain reaction (PCR) test or presence of serious clinical and radiological suspicion in the endemic process
- Being hospitalized for COVİD-19 infection
Who cannot join
- Those who do not agree to participate in the study
- Malignancy
- Orthopedic and neurological comorbidities that may interfere with evaluations
- Systemic rheumatic diseases
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Medicine, Physical Medicine and Rehabilitation Department
Ankara, 06560
About this study
Official title: Evaluation of Muscle Strength, Functional Independence, Myalgia Severity, Physical Fatigue and Dyspnea in Patients With COVID-19 Infection
Coronavirus disease 2019 (COVID-19) is a serious, acute infectious disease caused by Serious Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). COVID-19 can manifest itself in a wide variety of clinical scenarios. Asymptomatic disease, mild flu findings, pneumonia accompanied by acute respiratory failure, acute respiratory distress syndrome (ARDS) requiring hospitalization in the intensive care unit, and death are possible clinical consequences.
Myalgia, fatigue, and muscle weakness are reported regardless of the severity of the clinical presentation of COVID-19. Data on the prevalence and severity of muscle disorders and weakness during hospitalization and discharge due to COVID-19 disease are limited.
The aim of this study is to evaluate muscle strength, functional independence, myalgia severity, physical fatigue and dyspnea in hospitalized COVID-19 patients.
Read the detailed description
Coronavirus disease 2019 (COVID-19) is a serious, acute infectious disease caused by Serious Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). On March 11, 2020, the World Health Organization declared a pandemic due to COVID-19 disease transmitted from person to person. Positive COVID-19 patients are classified as asymptomatic, mild, moderate, severe and critical. Asymptomatic patients have no clinical symptoms, mild cases present with acute symptoms of respiratory tract infection and gastrointestinal complaints. Moderate patients experience pneumonia, they don't have clinically aberrant hypoxemia but they have positive findings on chest computerized tomography (CT) scans. Severe patients present with pneumonia ,they have hypoxemia and CT lesions while critical patients present with acute respiratory distress syndrome (ARDS), and shock, encephalopathy, myocardial injury, coagulation dysfunction, heart failure, acute kidney injury may accompany ARDS.
Myalgia, fatigue, and muscle weakness are reported regardless of the severity of the clinical presentation of COVID-19 disease. Data on the prevalence and severity of muscle disorders and weakness during hospitalization and discharge due to COVID-19 disease are limited.
Changes associated with critical disease myopathy triggered by the virus are reported in COVID-19 survivors.
In addition, immune-induced focal myofibril atrophy and necrosis have been documented in post-mortem examinations of patients with severe acute respiratory syndrome (SARS). An increase in the risk of acute sarcopenia and muscle weakness has been reported in survivors of COVID-19. Possible mechanisms of sarcopenia in COVID-19 disease are: suppression of muscle protein synthesis due to systemic inflammation and increased cytokine response, prolonged bed rest especially in intensive care patients, prolonged use of muscle relaxants to maintain the prone position, increased need for nutrients due to the catabolic state, inadequate nutrition due to decreased appetite and induction of muscle loss by dexamethasone used in COVID-19 treatment.
The aim of this study is to evaluate muscle strength, functional independence, myalgia severity, physical fatigue and dyspnea in hospitalized COVID-19 patients and to investigate whether these variables differ between the mild, moderate and severe groups according to the severity of the disease. The secondary aim of the study is to investigate the relationship between muscle strength and prognostic markers of COVID-19 disease (lymphocyte count, D-dimer, c-reactive protein, ferritin).
- Conditions
- Covid19
- Keywords
- covid19, muscle weakness, functional independence, myalgia, fatigue, dyspnea
- Medical subject headings
- COVID-19, Muscle Weakness, Myalgia, Fatigue, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mild COVID-19 Infection Group | Mild cases present with acute symptoms of respiratory tract infection and gastrointestinal complaints. | |
| Moderate COVID-19 Infection Group | Moderate patients experience pneumonia, they don't have clinically aberrant hypoxemia(O2 saturation is more than 90%) but they have positive findings on chest computerized tomography (CT) scans. | |
| Severe COVID-19 Infection Group | Severe patients present with pneumonia, they have hypoxemia (O2 saturation is less than 90%) and have positive findings on chest computerized tomography (CT) scans. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Muscle Strength at 1st week, 3rd week and 12th week.
Hand grip strength will be used to assess muscle strength. Hand grip strength is an important indicator of overall muscle strength. Measurements will be made with a Jamar dynamometer. Measurements will be done in the standard position recommended by the American Hand Therapists Association; shoulder in adduction and neutral rotation, elbow in 90 degrees of flexion, and wrist in neutral position.
3 measurements will be made with 1-minute intervals between measurements and the highest value will be recorded in kg. Threshold value for hand grip strength is 28.6 in men and 16.4 in women.
Measured: Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.
Secondary outcomes (4)
Change from Baseline '5 Times Sit to Stand Test' at 1st week, 3rd week and 12th week.
The 5 times sit to stand test will be used to assess the functional strength of the lower extremity and balance. The patient is asked to sit in a standard 43-45 cm high chair with his arms crossed on his shoulders and his back leaning against the chair. Then he is asked to stand up and sit up quickly 5 times. With the "start" command, the time elapsed until the person's pelvis touches the chair in the last repetition is recorded with a stopwatch.
Measured: Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.
Change from Baseline Modified Borg Scale at 1st week, 3rd week and 12th week.
This scale has been developed to measure the feeling of exertion and fatigue during physical activity. It is a scale that is frequently used to evaluate the severity of effort dyspnea and the severity of resting dyspnea. It is a 12-point scale that defines the severity of dyspnea according to their degrees. Descriptors are positioned on the scale, at different numbers, from 0 to 10. At one end of the scale '0' is labeled nothing at all' and at the other end, '10' is labeled' maximal.It will be used to measure symptoms of dyspnea and fatigue detected during rest and activities of daily living.
Measured: Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.
Change from Baseline Barthel Index for Activities of Daily Living at 1st week, 3rd week and 12th week.
It is a scale consisting of 10 items and measuring the performance in activities of daily living.Higher scores reflect better ability to function independently.
Measured: Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.
Change from Baseline Visual Analog Scale at 1st week, 3rd week and 12th week.
Myalgia will be assessed by visual analog scale (VAS). A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Two extreme definitions of pain (0: no pain, 10: The most powerful pain one can experience) are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line or by marking or pointing on this line.
Measured: Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Mar 2021
- Primary completion6 Sep 2021
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Utkan Karasu, Gazi University
- Investigators
- Ayça Utkan Karasu, MD, Principal investigator, Gazi University Faculty of MedicineZafer Günendi, MD, Principal investigator, Gazi University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784546
- Sponsor's protocol ID
- Gazi University PMR INF
- Status last verified
- Oct 2021
- First submitted
- 1 Mar 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
Pollard CA, Morran MP, Nestor-Kalinoski AL. The COVID-19 pandemic: a global health crisis. Physiol Genomics. 2020 Nov 1;52(11):549-557. doi: 10.1152/physiolgenomics.00089.2020. Epub 2020 Sep 29.
PubMed 32991251Paneroni M, Simonelli C, Saleri M, Bertacchini L, Venturelli M, Troosters T, Ambrosino N, Vitacca M. Muscle Strength and Physical Performance in Patients Without Previous Disabilities Recovering From COVID-19 Pneumonia. Am J Phys Med Rehabil. 2021 Feb 1;100(2):105-109. doi: 10.1097/PHM.0000000000001641.
PubMed 33181531Van Aerde N, Van den Berghe G, Wilmer A, Gosselink R, Hermans G; COVID-19 Consortium. Intensive care unit acquired muscle weakness in COVID-19 patients. Intensive Care Med. 2020 Nov;46(11):2083-2085. doi: 10.1007/s00134-020-06244-7. Epub 2020 Sep 28. No abstract available.
PubMed 32986233Leung TW, Wong KS, Hui AC, To KF, Lai ST, Ng WF, Ng HK. Myopathic changes associated with severe acute respiratory syndrome: a postmortem case series. Arch Neurol. 2005 Jul;62(7):1113-7. doi: 10.1001/archneur.62.7.1113.
PubMed 16009768Disser NP, De Micheli AJ, Schonk MM, Konnaris MA, Piacentini AN, Edon DL, Toresdahl BG, Rodeo SA, Casey EK, Mendias CL. Musculoskeletal Consequences of COVID-19. J Bone Joint Surg Am. 2020 Jul 15;102(14):1197-1204. doi: 10.2106/JBJS.20.00847.
PubMed 32675661Bagnato S, Boccagni C, Marino G, Prestandrea C, D'Agostino T, Rubino F. Critical illness myopathy after COVID-19. Int J Infect Dis. 2020 Oct;99:276-278. doi: 10.1016/j.ijid.2020.07.072. Epub 2020 Aug 5.
PubMed 32763444Welch C, Greig C, Masud T, Wilson D, Jackson TA. COVID-19 and Acute Sarcopenia. Aging Dis. 2020 Dec 1;11(6):1345-1351. doi: 10.14336/AD.2020.1014. eCollection 2020 Dec.
PubMed 33269092Karasu AU, Karatas L, Yildiz Y, Gunendi Z. Natural Course of Muscular Strength, Physical Performance, and Musculoskeletal Symptoms in Hospitalized Patients With COVID-19. Arch Phys Med Rehabil. 2023 Jan;104(1):18-26. doi: 10.1016/j.apmr.2022.09.001. Epub 2022 Sep 11.
PubMed 36103903
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Muscle Strength, Functional Independence, Myalgia Severity, Physical Fatigue and Dyspnea in Patients With COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04784546
- Acronym / sponsor ID
- Gazi University PMR INF
- Conditions
- Covid19
- Keywords
- covid19, muscle weakness, functional independence, myalgia, fatigue, dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronavirus disease 2019 (COVID-19) is a serious, acute infectious disease caused by Serious Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). COVID-19 can manifest itself in a wide variety of clinical scenarios. Asymptomatic disease, mild flu findings, pneumonia accompanied by acute respiratory failure, acute respiratory distress syndrome (ARDS) requiring hospitalization in the intensive care unit, and death are possible clinical consequences.
Myalgia, fatigue, and muscle weakness are reported regardless of the severity of the clinical presentation of COVID-19. Data on the prevalence and severity of muscle disorders and weakness during hospitalization and discharge due to COVID-19 disease are limited.
The aim of this study is to evaluate muscle strength, functional independence, myalgia severity, physical fatigue and dyspnea in hospitalized COVID-19 patients.
Detailed description
Coronavirus disease 2019 (COVID-19) is a serious, acute infectious disease caused by Serious Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). On March 11, 2020, the World Health Organization declared a pandemic due to COVID-19 disease transmitted from person to person. Positive COVID-19 patients are classified as asymptomatic, mild, moderate, severe and critical. Asymptomatic patients have no clinical symptoms, mild cases present with acute symptoms of respiratory tract infection and gastrointestinal complaints. Moderate patients experience pneumonia, they don't have clinically aberrant hypoxemia but they have positive findings on chest computerized tomography (CT) scans. Severe patients present with pneumonia ,they have hypoxemia and CT lesions while critical patients present with acute respiratory distress syndrome (ARDS), and shock, encephalopathy, myocardial injury, coagulation dysfunction, heart failure, acute kidney injury may accompany ARDS.
Myalgia, fatigue, and muscle weakness are reported regardless of the severity of the clinical presentation of COVID-19 disease. Data on the prevalence and severity of muscle disorders and weakness during hospitalization and discharge due to COVID-19 disease are limited.
Changes associated with critical disease myopathy triggered by the virus are reported in COVID-19 survivors.
In addition, immune-induced focal myofibril atrophy and necrosis have been documented in post-mortem examinations of patients with severe acute respiratory syndrome (SARS). An increase in the risk of acute sarcopenia and muscle weakness has been reported in survivors of COVID-19. Possible mechanisms of sarcopenia in COVID-19 disease are: suppression of muscle protein synthesis due to systemic inflammation and increased cytokine response, prolonged bed rest especially in intensive care patients, prolonged use of muscle relaxants to maintain the prone position, increased need for nutrients due to the catabolic state, inadequate nutrition due to decreased appetite and induction of muscle loss by dexamethasone used in COVID-19 treatment.
The aim of this study is to evaluate muscle strength, functional independence, myalgia severity, physical fatigue and dyspnea in hospitalized COVID-19 patients and to investigate whether these variables differ between the mild, moderate and severe groups according to the severity of the disease. The secondary aim of the study is to investigate the relationship between muscle strength and prognostic markers of COVID-19 disease (lymphocyte count, D-dimer, c-reactive protein, ferritin).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild COVID-19 Infection Group | – | –Mild cases present with acute symptoms of respiratory tract infection and gastrointestinal complaints. |
| Moderate COVID-19 Infection Group | – | –Moderate patients experience pneumonia, they don't have clinically aberrant hypoxemia(O2 saturation is more than 90%) but they have positive findings on chest computerized tomography (CT) scans. |
| Severe COVID-19 Infection Group | – | –Severe patients present with pneumonia, they have hypoxemia (O2 saturation is less than 90%) and have positive findings on chest computerized tomography (CT) scans. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort will consist of patients receiving inpatient treatment for mild, moderate and severe COVID-19 infection in a university hospital. Every subject meeting the criteria of inclusion is going to be included into the study via consecutive participant sampling method.
Key inclusion criteria (3 listed)
- 18-85 years of age
- SARS-CoV-2 infection to be confirmed by polymerase chain reaction (PCR) test or presence of serious clinical and radiological suspicion in the endemic process
- Being hospitalized for COVİD-19 infection
Key exclusion criteria (5 listed)
- Those who do not agree to participate in the study
- Malignancy
- Orthopedic and neurological comorbidities that may interfere with evaluations
- Systemic rheumatic diseases
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline Muscle Strength at 1st week, 3rd week and 12th week.
Time frame: Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.
Hand grip strength will be used to assess muscle strength. Hand grip strength is an important indicator of overall muscle strength. Measurements will be made with a Jamar dynamometer. Measurements will be done in the standard position recommended by the American Hand Therapists Association; shoulder in adduction and neutral rotation, elbow in 90 degrees of flexion, and wrist in neutral position. 3 measurements will be made with 1-minute intervals between measurements and the highest value will be recorded in kg. Threshold value for hand grip strength is 28.6 in men and 16.4 in women.
4 secondary outcomes
Change from Baseline '5 Times Sit to Stand Test' at 1st week, 3rd week and 12th week.
Time frame: Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.
Change from Baseline Modified Borg Scale at 1st week, 3rd week and 12th week.
Time frame: Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.
Change from Baseline Barthel Index for Activities of Daily Living at 1st week, 3rd week and 12th week.
Time frame: Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.
Change from Baseline Visual Analog Scale at 1st week, 3rd week and 12th week.
Time frame: Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Background: PubMed 32991251Pollard CA, Morran MP, Nestor-Kalinoski AL. The COVID-19 pandemic: a global health crisis. Physiol Genomics. 2020 Nov 1;52(11):549-557. doi: 10.1152/physiolgenomics.00089.2020. Epub 2020 Sep 29.
- Background: PubMed 33181531Paneroni M, Simonelli C, Saleri M, Bertacchini L, Venturelli M, Troosters T, Ambrosino N, Vitacca M. Muscle Strength and Physical Performance in Patients Without Previous Disabilities Recovering From COVID-19 Pneumonia. Am J Phys Med Rehabil. 2021 Feb 1;100(2):105-109. doi: 10.1097/PHM.0000000000001641.
- Background: PubMed 32986233Van Aerde N, Van den Berghe G, Wilmer A, Gosselink R, Hermans G; COVID-19 Consortium. Intensive care unit acquired muscle weakness in COVID-19 patients. Intensive Care Med. 2020 Nov;46(11):2083-2085. doi: 10.1007/s00134-020-06244-7. Epub 2020 Sep 28. No abstract available.
- Background: PubMed 16009768Leung TW, Wong KS, Hui AC, To KF, Lai ST, Ng WF, Ng HK. Myopathic changes associated with severe acute respiratory syndrome: a postmortem case series. Arch Neurol. 2005 Jul;62(7):1113-7. doi: 10.1001/archneur.62.7.1113.
- Background: PubMed 32675661Disser NP, De Micheli AJ, Schonk MM, Konnaris MA, Piacentini AN, Edon DL, Toresdahl BG, Rodeo SA, Casey EK, Mendias CL. Musculoskeletal Consequences of COVID-19. J Bone Joint Surg Am. 2020 Jul 15;102(14):1197-1204. doi: 10.2106/JBJS.20.00847.
- Background: PubMed 32763444Bagnato S, Boccagni C, Marino G, Prestandrea C, D'Agostino T, Rubino F. Critical illness myopathy after COVID-19. Int J Infect Dis. 2020 Oct;99:276-278. doi: 10.1016/j.ijid.2020.07.072. Epub 2020 Aug 5.
- Background: PubMed 33269092Welch C, Greig C, Masud T, Wilson D, Jackson TA. COVID-19 and Acute Sarcopenia. Aging Dis. 2020 Dec 1;11(6):1345-1351. doi: 10.14336/AD.2020.1014. eCollection 2020 Dec.
- Derived from this study: PubMed 36103903Karasu AU, Karatas L, Yildiz Y, Gunendi Z. Natural Course of Muscular Strength, Physical Performance, and Musculoskeletal Symptoms in Hospitalized Patients With COVID-19. Arch Phys Med Rehabil. 2023 Jan;104(1):18-26. doi: 10.1016/j.apmr.2022.09.001. Epub 2022 Sep 11.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayça Utkan Karasu, MD principal investigator
Gazi University Faculty of Medicine
Zafer Günendi, MD principal investigator
Gazi University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Muscle Strength at 1st week, 3rd week and 12th week. (time frame: Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04784546, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.