Evaluation of the Effects of Treatment With Bioarginin C in Adult Subjects Belonging to the Post-Covid Day Hospital
BC
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 18, 2021
CompletedFirst Submitted
Initial submission to the registry
June 30, 2021
CompletedFirst Posted
Study publicly available on registry
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2022
CompletedMay 17, 2022
May 1, 2022
1.3 years
June 30, 2021
May 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
6 minute walking test to evaluate Fatigue
Effect of Bioarginina C on the prolonged fatigue
30 days
Study Arms (2)
Bioarginina C
ACTIVE COMPARATORvials based on L-arginine and liposomal vitamin C
Placebo
PLACEBO COMPARATORvials without L-arginine and liposomal vitamin C
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Pharmacological therapies with possible interactions with the mechanisms / processes under study (e.g. antihypertensive drugs, cortisone drugs, NSAIDs, immunosuppressants, nitrates)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barbara Maglione
Napoli, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
June 30, 2021
First Posted
July 1, 2021
Study Start
June 18, 2021
Primary Completion
September 18, 2022
Study Completion
November 18, 2022
Last Updated
May 17, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share