Fatigue Syndrome, ChronicBCNCT04947488
Evaluation of the Effects of Treatment With Bioarginin C in Adult Subjects Belonging to the Post-Covid Day Hospital
A study testing Bioarginina C in people with Fatigue Syndrome, Chronic and Inflammation, run by University of Milan at 1 site in Italy.
Trial summary
Long Covid could be much more frequent than it is thought to be. Few dwell on the great problem represented by the post covid syndrome. The virus often leaves important marks on our body, and those who recover face problems of various kinds: chronic fatigue, shortness of breath, dry cough, headache, cognitive… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue Syndrome, Chronic, Inflammation
- What is being tested?
- Bioarginina C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jun 2021to 18 Nov 2022
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- subjects with proven positivity to the molecular test for Sars-cov2 with demonstration of microbiological healing patients discharged from FPG or other hospital structures; or only contact in PS; or home management age: range 20-60 years Fatigue operationalized as an affirmative answer to item "7" (CES-D)
Who cannot join
- Pharmacological therapies with possible interactions with the mechanisms / processes under study (e.g. antihypertensive drugs, cortisone drugs, NSAIDs, immunosuppressants, nitrates)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Barbara Maglione
Naples
barbara o maglione, +393343293357 ext. +393343293357, barbara.maglione@farmadamor.it
About this study
Official title: Evaluation of the Effects of Treatment With Bioarginin C on Physical Exhaustion , Systemic Inflammatory State and Endothelial Function in Adult Subjects Belonging to the Post-Covid Day Hospital
Long Covid could be much more frequent than it is thought to be. Few dwell on the great problem represented by the post covid syndrome. The virus often leaves important marks on our body, and those who recover face problems of various kinds: chronic fatigue, shortness of breath, dry cough, headache, cognitive difficulties.
On the duration and resolution of this syndrome, now recognized as a highly debilitating condition, there are still no great answers: for this reason it is always important to emphasize that contracting Covid, even in a not serious form, still means exposing oneself to long-term risks that are still not well codified by the scientific community. Guidelines and more tools are expected to best assist these patients.
- Conditions
- Fatigue Syndrome, Chronic, Inflammation
- Being tested
- Bioarginina C
- Medical subject headings
- Fatigue Syndrome, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioarginina CDietary supplement
Dietary supplement vials
| Study group | Role | What they receive |
|---|---|---|
| Bioarginina C | Active comparator | vials based on L-arginine and liposomal vitamin C Receives: Dietary Supplement: Bioarginina C |
| Placebo | Placebo comparator | vials without L-arginine and liposomal vitamin C Receives: Dietary Supplement: Bioarginina C |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walking test to evaluate Fatigue
Effect of Bioarginina C on the prolonged fatigue
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start18 Jun 2021
- Primary completion18 Sep 2022 (estimated)
- Study completion18 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue Syndrome, ChronicStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Tosato, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947488
- Sponsor's protocol ID
- Bioarginina C
- Acronym
- BC
- Status last verified
- May 2022
- First submitted
- 30 Jun 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Treatment With Bioarginin C on Physical Exhaustion , Systemic Inflammatory State and Endothelial Function in Adult Subjects Belonging to the Post-Covid Day Hospital
- ClinicalTrials.gov ID
- NCT04947488
- Acronym / sponsor ID
- BC / Bioarginina C
- Conditions
- Fatigue Syndrome, Chronic, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 18 Sep 2022 (estimated)
- Study completion
- 18 Nov 2022 (estimated)
- First posted
- 1 Jul 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.
Long Covid could be much more frequent than it is thought to be. Few dwell on the great problem represented by the post covid syndrome. The virus often leaves important marks on our body, and those who recover face problems of various kinds: chronic fatigue, shortness of breath, dry cough, headache, cognitive difficulties.
On the duration and resolution of this syndrome, now recognized as a highly debilitating condition, there are still no great answers: for this reason it is always important to emphasize that contracting Covid, even in a not serious form, still means exposing oneself to long-term risks that are still not well codified by the scientific community. Guidelines and more tools are expected to best assist these patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioarginina C | Active comparator | Dietary Supplement: Bioarginina Cvials based on L-arginine and liposomal vitamin C |
| Placebo | Placebo comparator | Dietary Supplement: Bioarginina Cvials without L-arginine and liposomal vitamin C |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- subjects with proven positivity to the molecular test for Sars-cov2 with demonstration of microbiological healing patients discharged from FPG or other hospital structures; or only contact in PS; or home management age: range 20-60 years Fatigue operationalized as an affirmative answer to item "7" (CES-D)
Key exclusion criteria (1 listed)
- Pharmacological therapies with possible interactions with the mechanisms / processes under study (e.g. antihypertensive drugs, cortisone drugs, NSAIDs, immunosuppressants, nitrates)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioarginina CDietary supplement vials | Dietary supplement | Bioarginina C, Placebo |
Primary outcome
6 minute walking test to evaluate Fatigue
Time frame: 30 days
Effect of Bioarginina C on the prolonged fatigue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioarginina C in people with Fatigue Syndrome, Chronic and Inflammation, run by University of Milan at 1 site in Italy.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 May 2022. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact barbara maglione (+393343293357 ext. +393343293357, barbara.maglione@farmadamor.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walking test to evaluate Fatigue (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2022.