Back to resultsEvaluation of the Effects of Treatment With Bioarginin C in Adult Subjects Belonging to the Post-Covid Day Hospital (BC)
Primary Purpose
Fatigue Syndrome, Chronic, Inflammation
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Bioarginina C
Sponsored by
About this trial
This is an interventional supportive care trial for Fatigue Syndrome, Chronic
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Pharmacological therapies with possible interactions with the mechanisms / processes under study (e.g. antihypertensive drugs, cortisone drugs, NSAIDs, immunosuppressants, nitrates)
Sites / Locations
- Barbara MaglioneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Bioarginina C
Placebo
Arm Description
vials based on L-arginine and liposomal vitamin C
vials without L-arginine and liposomal vitamin C
Outcomes
Primary Outcome Measures
6 minute walking test to evaluate Fatigue
Effect of Bioarginina C on the prolonged fatigue
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04947488
Brief Title
Evaluation of the Effects of Treatment With Bioarginin C in Adult Subjects Belonging to the Post-Covid Day Hospital
Acronym
BC
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
September 18, 2022 (Anticipated)
Study Completion Date
November 18, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue Syndrome, Chronic, Inflammation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bioarginina C
Arm Type
Active Comparator
Arm Description
vials based on L-arginine and liposomal vitamin C
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
vials without L-arginine and liposomal vitamin C
Intervention Type
Dietary Supplement
Intervention Name(s)
Bioarginina C
Intervention Description
Dietary supplement vials
Primary Outcome Measure Information:
Title
6 minute walking test to evaluate Fatigue
Description
Effect of Bioarginina C on the prolonged fatigue
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Pharmacological therapies with possible interactions with the mechanisms / processes under study (e.g. antihypertensive drugs, cortisone drugs, NSAIDs, immunosuppressants, nitrates)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
barbara maglione
Phone
+393343293357
Ext
+393343293357
Email
barbara.maglione@farmadamor.it
Facility Information:
Facility Name
Barbara Maglione
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
barbara o maglione
Phone
+393343293357
Ext
+393343293357
Email
barbara.maglione@farmadamor.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Effects of Treatment With Bioarginin C in Adult Subjects Belonging to the Post-Covid Day Hospital
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