Clinical trial NCT05531019: COVID-19 Sequelae: Treatment and Monitoring. A Dietary Supplement Based on Sea Urchin Eggs With Echinochroma A
Official title: COVID-19 Sequelae: Treatment and Monitoring of Persistent Symptoms, a Decentralized Approach Focus on the Patient. Use of Dietary Supplement Based on Sea Urchin Eggs With Echinochroma A.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long COVID
Keywords: Covid-19
sequalae
long covid
lung
telemedicine
brain
biomarker
Lead sponsor: Hospital Donación Francisco Santojanni
Sponsor class: OTHER
Collaborators: name: Universidad Nacional de la Patagonia San Juan Bosco
name: Ministerio de Ciencia, Tecnologia e Innovación, Argentina
name: Hospital de Infecciosas Francisco Javier Muniz
First posted: 2022-09-07
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Ramdomized Control
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the efficacy and efficiency of a nutraceutical from sea urchin eggs with Echinochrome A in the inflammation of tissues in subjects with long Corona Virus (COVID) syndome

Detailed description: This is a double-blind placebo-controlled study in approximately 60 subjects with long COVID syndrome. After being informed about the study and potential risks, all subjects giving written informed consent will be screened to assess initial respiratory, cardiological inflammatory, neurological and emotional conditions. Prior to the first administration of the treatment, subjetcs will be randomized to receive three vials of the Dietary Supplement with sea urchin eggs extract with presence of the antioxidant Echinochrome A or placebo. According with the ACRO suggestions this study is focus on the patients. Subjects will be monitor by a Telemedicine platform called SkyMed developed for this study to assess their health daily and will have a weekly virtual meeting with a counselors to assess emotional state. Subjects will attend tp the Hospital, at the beggining of the study, and after finishing the vials of the Dietary Supplement (30, 60 and 90 days). Clinical, cardiological, neumonological and neurological studies will carried out to asses the systemic health as well as the quality of life indicators. Inflammation, trombolotic and inmune indicators will be assess in blood samples (basal, 30, 60 and 90 days).

The main objetivec behind this clinical trial is to diminish ROS in the cells, enhance gluthation pathways and diminish cellular inflammation. Echinochrome A is a powerfull marine poliphenol with known antioxidant activity found in the eggs, shells and spines of sea urchins, that had been use in eastern medicien for a long time. Powder of sea urchin eggs are mention in Materia Medica back far 1647 as a powerfull anti inflamation agent.

Eligibility criteria: Inclusion Criteria:

1. Positive diagnosis of COVID-19 in at least the last 12 weeks
2. Diagnosis of COVID Persistent, COVID sequalea, Long COVID
3. Adult men or non-pregnant adult women between the ages of 18 and 60.
4. The patient (or legally authorized representative) provides your informed consent before initiating any study procedure.
5. The patient (or legally authorized representative) understands and agrees comply with the planned study procedures. 6. Agreement not to participate in another trial ofintervention for the treatment of COVID-19 until day 60 after the start of the trial.

Exclusion Criteria:

* 1. Patients without persistent COVID symptoms. 2. Patients unable to give informed consent. 3. Patients without a positive result for COVID-19. 4. Pregnancy or lactation. 5. In the doctor's opinion, the patient with advanced organ dysfunction that would not make participation appropriate.

Primary outcomes:
measure: Change of symptoms over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) during rutine medical checkup.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change of lung capacity over four times (baseline, 4 weeks, 8 weeks, 12 weeks) assessed during spirometry.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change of walking distance during a six minutes walk test (6MWT) over time-points (baseline, 4 weeks, 8 weeks, 12 weeks)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change of depression measured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via the Beck Health Questionnaire.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in the quality of life meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via visual analog scale of EuroQol (EQ-VAS).
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Presence or absence of Myocarditis meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via electrocardiogram.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Trial Making test (TMT).
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Phonological verbal fluency test.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Frontal assessment battery (FAB).
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via clock test (CDT).
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Analogies (WAIS-III).
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in the memory over time-points ) baseline, 4 weeks, 8 weeks, 12 weeks) via Rey Auditory Verbal Learning Test.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in the memory over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via the memory failures of every-day (MFE)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in the overall cognitive ability over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) assessed during Addenbrooke's Cognitive Examination Revised (ACE-R) test.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in the overall memory over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) assessed during Digit Span (WAIS-III): Forward.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in the assess aspects such as selective attention and inhibitory control over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Stroop test.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Changes in the expression of language over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Boston Nomination Test.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Changes in the expression of language over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via semantic Verbal Fluency test.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Changes in sleep behaviors over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Changes in concussion over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via king figure method.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Changes in olfactory-specific quality of life over time-points (baseline, 4 weeñs, 8 weeks, 12 weeks) via questionnaire of olfactory disorders-negative statements (QOD-NS) and a short version of QOD-NS (sQOD-NS).
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Changes in dyspnea scale over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via modified Medical Research Council (mMRC) dyspnoea scale.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in scale of Asthenia over time-point (baseline, 4 weeks, 8 weeks, 12 weeks) via asthenia scale.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in Fatigue scale over time-point (baseline, 4 weeks, 8 weeks, 12 weeks) via Krupp Clader CFQ-11 Fatigue Intensity Scale.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in Emotions scale over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Brackets RULER scale.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: Change of Von Willebrand Factor over time-points (baseline, 4 weeks, 12 weeks, 12 weeks) via blood sample.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change of D Dimer over time-points (baseline, 4 weeks, 12 weeks, 12 weeks) via blood sample.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change of HS-CRP over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via blood sample.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change of Ferritin over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via blood sample.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
measure: Change of the emotional state over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Plutchik's Wheel of Emotions.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change of the emotional state over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Scale Revised by Event Impacts.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change of the emotional state over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Mood Person Centered Approach.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Donación Francisco Santojanni
Study officials:
affiliation: Universidad Nacional de la Patagonia San Juan Bosco
name: Tamara Rubilar, PhD
role: PRINCIPAL_INVESTIGATOR
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