Long COVIDNCT05531019

COVID-19 Sequelae: Treatment and Monitoring. A Dietary Supplement Based on Sea Urchin Eggs With Echinochroma A

A study testing Echinochrome A in people with Long COVID, run by Fernando Saldarini at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Long COVID
What is being tested?: Echinochrome A
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 1 siteArgentina
Study dates: 22 Sep 2021to 18 Dec 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 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Positive diagnosis of COVID-19 in at least the last 12 weeks
Diagnosis of COVID Persistent, COVID sequalea, Long COVID
Adult men or non-pregnant adult women between the ages of 18 and 60.
The patient (or legally authorized representative) provides your informed consent before initiating any study procedure.
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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

Hospital Donación Francisco Santojanni
Buenos Aires, 1408

Other trials in Argentina

About this study

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.

Read the 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.

Conditions: Long COVID
Being tested: Echinochrome A, Control
Keywords: Covid-19, sequalae, long covid, lung, telemedicine, brain, biomarker
Medical subject headings: Post-Acute COVID-19 Syndrome, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Echinochrome ADietary supplement
Also called EchA Marine
Dietary Supplement with Echinochroma A Simple randomized design, in this arm patients will take 6ml of a 0.025% Echinochroma A solution twice a day for 90 days. 3 mg of Echinochroma A will be consumed per day.
ControlOther
Simple randomized design, in this arm patients will take 6ml of an fructose aqueous solution twice a day for 90 days with the same flavor as the treatment

Study groups in NCT05531019
Study group	Role	What they receive
Dietary Supplement with sea urchin egg extract	Experimental	Ingestion of dietary supplement with 0,025% of Echinochrome A (ingested 3ml twice a day for 90 days), 1,5mg daily consumption from sea urchin egg extract (Arbacia dufresnii) Receives: Dietary Supplement: Echinochrome A
Control	Placebo comparator	Ingestion of 3ml twice a day for 90 days of placebo Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of symptoms over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) during rutine medical checkup.
Measuring the symptoms as presence o absence of chest pain, cough, headache, sleep disorders, dysgeusia, myalgia, arthralgia.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change of lung capacity over four times (baseline, 4 weeks, 8 weeks, 12 weeks) assessed during spirometry.
The main variables of forced spirometry that are measured are the forced vital capacity (FVC) and the forced expiratory volume in the first second (FEV1). The FVC represents the maximum volume of air exhaled in a maximal effort expiratory maneuver, initiated after a maximal inspiration maneuver, expressed in liters. FEV1 corresponds to the maximum volume of air exhaled in the first second of the FVC maneuver, also expressed in liters. In turn, the FEV1/FVC ratio shows the relationship between both parameters.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change of walking distance during a six minutes walk test (6MWT) over time-points (baseline, 4 weeks, 8 weeks, 12 weeks)
The 6MWT is used, among other things, to assess and control cardiovascular and pulmonary performance below the anaerobic threshold. This test is used for the clinical evaluation of the basic motor property endurance and measures the distance a patient can walk as quickly as possible on a flat, hard surface in a period of 6 minutes. It will be measured in meters.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change of depression measured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via the Beck Health Questionnaire.
The Beck Anxiety Inventory is a useful tool to assess somatic symptoms of anxiety, both in anxiety disorders and depressive symptoms. The questionnaire consists of 21 questions, providing a score range between 0 and 63.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
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).
EQ-VAS which is a scale of 0 to 100 that allows individuals to place themselves according to how they perceive their overall health status (0 is the worst and 100 the best health status)
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Presence or absence of Myocarditis meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via electrocardiogram.
Electrocardiographic signs in patients with myocarditis include T-wave and ST-segment abnormalities, ST-segment elevation
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Trial Making test (TMT).
The TMT is timed (seconds) and performed in two parts using only a pen and a piece of paper.It can provide insights into a person's cognitive function based on how fast they can search, scan, and process visual information without losing track of what they are doing.The test also provides information about a person's mental flexibility.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Phonological verbal fluency test.
Verbal fluency tests are commonly used to investigate lexical skills and semantic knowledge. for number of words beginning with the letters F, A, and S and for to al number of words beginning with either letter generated per minute.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Frontal assessment battery (FAB).
The Frontal Assessment Battery (FAB) is a cognitive test that incorporates several clinical assessments to screen for frontotemporal dementia (FTD), including S-word generation, similarities, Luria's test, grasp reflex, and the Go-No-Go test.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via clock test (CDT).
The CDT is used to quickly assess visuospatial and praxis abilities, and may determine the presence or absence of both attention and executive dysfunctions: ask the patient to draw the face of a clock and then to draw the hands to indicate a particular time.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Analogies (WAIS-III).
Wais-III is an instrument for assessing Verbal Comprehension, it refers to conceptualization, knowledge and verbal expression. The subject must answer questions that measure practical knowledge, word meanings, reasoning, and the ability to express ideas in words. The Analogies subtest assesses fluid intelligence where the subject's ability to solve new problems that do not depend on schooling or formal culture is reflected: before a series of words presented, the examinee must explain the similarity of common objects or concepts that those terms represent. Maximum direct score 33 points.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in the memory over time-points ) baseline, 4 weeks, 8 weeks, 12 weeks) via Rey Auditory Verbal Learning Test.
The test is designed as a list-learning paradigm in which the patient hears a list of 15 nouns and is asked to recall as many words from the list as possible. After five repetitions of free-recall, a second "interference" list (List B) is presented in the same manner, and the participant is asked to recall as many words from List B as possible. After the interference trial, the participant is immediately asked to recall the words from List A, which she or he heard five times previously. After a 20 min delay, the participant is asked to again recall the words from List A. After this "delayed recall" task, a list of 50 words is presented containing all of the words from Lists A. The score given for each trial is the total number of words recalled. Normal scores are 6 words hit on the first trial and 12 or 13 on the fifth trial.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in the memory over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via the memory failures of every-day (MFE)
The Memory Failures of Everyday-MFE Questionnaire was used for the subjective assessment of memory. It consists of 28 items on situations and activities of daily living. Each item was scored on a 0-2 point scale ("never or rarely", "sometimes", "many times").
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
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.
The ACE-R takes between 12 and 20 min (average 16) to administer and score in a clinical setting. It contains 5 sub-scores, each one representing one cognitive domain: attention/orientation (18 points), memory (26 points), fluency (14 points), language (26 points) and visuospatial (16 points). ACE-R maximum score is 100, composed by the addition of the all domains
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in the overall memory over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) assessed during Digit Span (WAIS-III): Forward.
The Digit Span score is the length of the longest correctly repeated sequence. The idea was to test how much a person can receive, process and remember for a variety of elements. On average a person is not capable of retaining more than 7 pieces of information. This means that when the longest repeated sequence is 7, the participant reached level 7. The test was assessed in forward orders of the digits.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
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.
Throughout the Stroop test, a total of three different tasks are carried out, through three sheets in which five columns of 20 elements appear. Each one of the tasks is carried out during a certain time (for example, forty-five seconds), scoring the successes for later evaluation. The successes that the subject has had during the test or the time it takes to react to the stimulation are valued, paying attention to what is reflected in each of the sheets or tasks.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Changes in the expression of language over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Boston Nomination Test.
The Boston vocabulary test consists of 60 figures, ordered from the easiest to the most difficult. The figures are presented in order, allowing the subject 20 seconds to respond. The scores provided by the test are: - The number of correct answers given spontaneously.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Changes in the expression of language over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via semantic Verbal Fluency test.
The Semantic Verbal Fluency (SVF) test entails the generation of words from a given category within a pre-set time of 60 seconds.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Changes in sleep behaviors over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is the most widely used sleep questionnaire in adults, consisting of 24 questions. The first 19 questions are answered by the evaluated person taking into account what they have experienced during the last month.
Resultados de traducción Sleep quality index (PSQI)
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Changes in concussion over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via king figure method.
Demonstration and test cards for the King-Devick test, a candidate rapid sideline screening for concussion based on speed of rapid number naming. To perform the King-Devick test, participants are asked to read the numbers on each card from left to right as quickly as possible, but without making any errors. Following completion of the demonstration card (upper left), subjects are then asked to read each of the three test cards in the same manner. The times required to complete each card are recorded in seconds using a stopwatch. The sum of the three test card time scores constitutes the summary score for the entire test, the King-Devick time score. Numbers of errors made in reading the test cards are also recorded; misspeaks on numbers are recorded as errors only if the subject does not immediately correct the mistake before going on to the next number.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
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).
The QOD-NS questionnaire consists of 17 negative statements about the degree to which patients suffered from olfactory impairment. Patients can agree, partly agree, partly disagree, or disagree in each statement which ranges from 0 to 3. A total score of 0-51 is calculated with higher scores reflecting worse olfactory-specific quality of life. For the sQOD-NS questionnaire composed of 7 items, the total scores range from 0 to 21.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Changes in dyspnea scale over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via modified Medical Research Council (mMRC) dyspnoea scale.
The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in scale of Asthenia over time-point (baseline, 4 weeks, 8 weeks, 12 weeks) via asthenia scale.
Analog scale from 0 to 100 mm
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in Fatigue scale over time-point (baseline, 4 weeks, 8 weeks, 12 weeks) via Krupp Clader CFQ-11 Fatigue Intensity Scale.
The Chalder Fatigue Questionnaire (CFQ) also referred to as the Chalder Fatigue Scale, is an 11-item questionnaire measuring the severity of physical and mental fatigue on two separate subscales. Seven items represent physical fatigue (items 1-7) and 4 represent mental fatigue (items 8-11). Each item is scored 0-3; less than usual (0), no more than usual (1), more than usual (2) and much more than usual (3). The ratings of items are added together to calculate the total score (range=0-33). High scores represent high levels of fatigue.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in Emotions scale over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Brackets RULER scale.
Brackets' RULER syllabus consists of five key skills, which anyone can learn. The acronym "RULER" stands for Recognize, Understand, Label, Express, and Regulate. The first three skills allow us to practice identifying our emotions. The last two allow us to develop the necessary skills to deal with them. The RULER curriculum is about gathering information by recognizing and understanding emotions. Apply emotional intelligence to various situations.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary outcomes (4)

Change of Von Willebrand Factor over time-points (baseline, 4 weeks, 12 weeks, 12 weeks) via blood sample.
Von Willebrand factor will be measured by an automated, highly sensitive and specific immuno-turbidimetric assay (Liatest antigenic Stago, France. VWF in %. VWF an "acute phase protein" which increases in infections (bacterial, less viral and fungi), inflammation, post-OP, malignant processes, and represent the best biomarkers as endothelial pertubation.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change of D Dimer over time-points (baseline, 4 weeks, 12 weeks, 12 weeks) via blood sample.
D Dimer (<500 ng/ml FEU) is altered in prothrombotic or thrombotic processes.plasma levels of D-Dimer will be measured by sandwich ELISA in citrated plasma (VIDAS D-Dimer, BioMerieux SA ).
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change of HS-CRP over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via blood sample.
CRP (< 0,5 mg/dl) is an "acute phase protein" which increases in infections (bacterial, less viral and fungi), inflammation, post-OP, malignant processes; ultra-sensitive CRP is additionally a risk assessment marker of aterosclerosis
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change of Ferritin over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via blood sample.
Ferritin (Men: 12 to 300 ng/mL Women: 12 to 150 ng/mL.) is an "acute phase protein" which increases in infections (bacterial, less viral and fungi), inflammation, post-OP, malignant processes.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Sep 202118 Dec 2022

First posted7 Sep 2022
Study start22 Sep 2021
Primary completion8 Dec 2022
Study completion18 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Long COVIDStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Ramdomized Control
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05531019
Sponsor's protocol ID: 5832
Status last verified: Feb 2023
First submitted: 19 Aug 2022
Last updated: 28 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All IPD that underlie results in a publication

Publications

Gorna R, MacDermott N, Rayner C, O'Hara M, Evans S, Agyen L, Nutland W, Rogers N, Hastie C. Long COVID guidelines need to reflect lived experience. Lancet. 2021 Feb 6;397(10273):455-457. doi: 10.1016/S0140-6736(20)32705-7. Epub 2020 Dec 23. No abstract available.
PubMed 33357467
Marshall M. The four most urgent questions about long COVID. Nature. 2021 Jun;594(7862):168-170. doi: 10.1038/d41586-021-01511-z. No abstract available.
PubMed 34108700
COVID-19 rapid guideline: managing the long-term effects of COVID-19. London: National Institute for Health and Care Excellence (NICE); 2024 Jan 25. Available from http://www.ncbi.nlm.nih.gov/books/NBK567261/
PubMed 33555768
S.E. de M.G. y de F. (SEMG), Guía clínica para la atención al paciente long COVID/COVID persistente, (2021) 1-12
Raveendran AV, Jayadevan R, Sashidharan S. Long COVID: An overview. Diabetes Metab Syndr. 2021 May-Jun;15(3):869-875. doi: 10.1016/j.dsx.2021.04.007. Epub 2021 Apr 20.
PubMed 33892403
Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31.
PubMed 32475821
D. Barron, Bringing the Clinical Trial to the Patient, Eye Pharma. (2017)
Rubilar T, Barbieri ES, Gazquez A, Avaro M. Sea Urchin Pigments: Echinochrome A and Its Potential Implication in the Cytokine Storm Syndrome. Mar Drugs. 2021 May 11;19(5):267. doi: 10.3390/md19050267.
PubMed 34064550
Artyukov AA, Zelepuga EA, Bogdanovich LN, Lupach NM, Novikov VL, Rutckova TA, Kozlovskaya EP. Marine Polyhydroxynaphthoquinone, Echinochrome A: Prevention of Atherosclerotic Inflammation and Probable Molecular Targets. J Clin Med. 2020 May 15;9(5):1494. doi: 10.3390/jcm9051494.
PubMed 32429179
Nabavi N. Long covid: How to define it and how to manage it. BMJ. 2020 Sep 7;370:m3489. doi: 10.1136/bmj.m3489. No abstract available.
PubMed 32895219
Mahase E. Long covid could be four different syndromes, review suggests. BMJ. 2020 Oct 14;371:m3981. doi: 10.1136/bmj.m3981. No abstract available.
PubMed 33055076
Altmann DM, Boyton RJ. Decoding the unknowns in long covid. BMJ. 2021 Feb 4;372:n132. doi: 10.1136/bmj.n132. No abstract available.
PubMed 33541867
Del Rio C, Collins LF, Malani P. Long-term Health Consequences of COVID-19. JAMA. 2020 Nov 3;324(17):1723-1724. doi: 10.1001/jama.2020.19719. No abstract available.
PubMed 33031513
P. Brito-Zerón, L. Conangla Ferrín, B. Kostov, A. Moragas Moreno, M. Ramos-Casals, E. Sequeira Aymar, A. Sisó Almirall, Manfestaciones persistentes de la COVID-19 . Guía de práctica clínica, 2020.
A.A. Artyukov, A.M. Popov, A. V. Tsybulsky, O.N. Krivoshapko, N. V. Polyakova, Pharmacological activity of echinochrome a alone and in the biologically active additive Timarin, Biochem. Suppl. Ser. B Biomed. Chem. (2013). https://doi.org/10.1134/S1990750813030025.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Long COVID trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT05531019
Acronym / sponsor ID: 5832
Conditions: Long COVID
Keywords: Covid-19, sequalae, long covid, lung, telemedicine, brain, biomarker
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Fernando SaldariniUniversity, hospital or other
Collaborators: Universidad Nacional de la Patagonia San Juan Bosco, Ministerio de Ciencia, Tecnologia e Innovación, Argentina, Hospital de Infecciosas Francisco Javier Muniz
Study start: 22 Sep 2021 (actual)
Primary completion: 8 Dec 2022 (actual)
Study completion: 18 Dec 2022 (actual)
First posted: 7 Sep 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Ramdomized Control

Arm	Type	Receives
Dietary Supplement with sea urchin egg extract	Experimental	Dietary Supplement: Echinochrome AIngestion of dietary supplement with 0,025% of Echinochrome A (ingested 3ml twice a day for 90 days), 1,5mg daily consumption from sea urchin egg extract (Arbacia dufresnii)
Control	Placebo comparator	Other: ControlIngestion of 3ml twice a day for 90 days of placebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Positive diagnosis of COVID-19 in at least the last 12 weeks
Diagnosis of COVID Persistent, COVID sequalea, Long COVID
Adult men or non-pregnant adult women between the ages of 18 and 60.
The patient (or legally authorized representative) provides your informed consent before initiating any study procedure.
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.

Key exclusion criteria (1 listed)

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.

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
Echinochrome AAlso: EchA MarineDietary Supplement with Echinochroma A Simple randomized design, in this arm patients will take 6ml of a 0.025% Echinochroma A solution twice a day for 90 days. 3 mg of Echinochroma A will be consumed per day.	Dietary supplement	Dietary Supplement with sea urchin egg extract
ControlSimple randomized design, in this arm patients will take 6ml of an fructose aqueous solution twice a day for 90 days with the same flavor as the treatment	Other	Control

Primary outcome

Change of symptoms over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) during rutine medical checkup.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Measuring the symptoms as presence o absence of chest pain, cough, headache, sleep disorders, dysgeusia, myalgia, arthralgia.
Change of lung capacity over four times (baseline, 4 weeks, 8 weeks, 12 weeks) assessed during spirometry.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The main variables of forced spirometry that are measured are the forced vital capacity (FVC) and the forced expiratory volume in the first second (FEV1). The FVC represents the maximum volume of air exhaled in a maximal effort expiratory maneuver, initiated after a maximal inspiration maneuver, expressed in liters. FEV1 corresponds to the maximum volume of air exhaled in the first second of the FVC maneuver, also expressed in liters. In turn, the FEV1/FVC ratio shows the relationship between both parameters.
Change of walking distance during a six minutes walk test (6MWT) over time-points (baseline, 4 weeks, 8 weeks, 12 weeks)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The 6MWT is used, among other things, to assess and control cardiovascular and pulmonary performance below the anaerobic threshold. This test is used for the clinical evaluation of the basic motor property endurance and measures the distance a patient can walk as quickly as possible on a flat, hard surface in a period of 6 minutes. It will be measured in meters.
Change of depression measured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via the Beck Health Questionnaire.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The Beck Anxiety Inventory is a useful tool to assess somatic symptoms of anxiety, both in anxiety disorders and depressive symptoms. The questionnaire consists of 21 questions, providing a score range between 0 and 63.
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).
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
EQ-VAS which is a scale of 0 to 100 that allows individuals to place themselves according to how they perceive their overall health status (0 is the worst and 100 the best health status)
Presence or absence of Myocarditis meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via electrocardiogram.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Electrocardiographic signs in patients with myocarditis include T-wave and ST-segment abnormalities, ST-segment elevation
Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Trial Making test (TMT).
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The TMT is timed (seconds) and performed in two parts using only a pen and a piece of paper.It can provide insights into a person's cognitive function based on how fast they can search, scan, and process visual information without losing track of what they are doing.The test also provides information about a person's mental flexibility.
Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Phonological verbal fluency test.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Verbal fluency tests are commonly used to investigate lexical skills and semantic knowledge. for number of words beginning with the letters F, A, and S and for to al number of words beginning with either letter generated per minute.
Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Frontal assessment battery (FAB).
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The Frontal Assessment Battery (FAB) is a cognitive test that incorporates several clinical assessments to screen for frontotemporal dementia (FTD), including S-word generation, similarities, Luria's test, grasp reflex, and the Go-No-Go test.
Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via clock test (CDT).
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The CDT is used to quickly assess visuospatial and praxis abilities, and may determine the presence or absence of both attention and executive dysfunctions: ask the patient to draw the face of a clock and then to draw the hands to indicate a particular time.
Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Analogies (WAIS-III).
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Wais-III is an instrument for assessing Verbal Comprehension, it refers to conceptualization, knowledge and verbal expression. The subject must answer questions that measure practical knowledge, word meanings, reasoning, and the ability to express ideas in words. The Analogies subtest assesses fluid intelligence where the subject's ability to solve new problems that do not depend on schooling or formal culture is reflected: before a series of words presented, the examinee must explain the similarity of common objects or concepts that those terms represent. Maximum direct score 33 points.
Change in the memory over time-points ) baseline, 4 weeks, 8 weeks, 12 weeks) via Rey Auditory Verbal Learning Test.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The test is designed as a list-learning paradigm in which the patient hears a list of 15 nouns and is asked to recall as many words from the list as possible. After five repetitions of free-recall, a second "interference" list (List B) is presented in the same manner, and the participant is asked to recall as many words from List B as possible. After the interference trial, the participant is immediately asked to recall the words from List A, which she or he heard five times previously. After a 20 min delay, the participant is asked to again recall the words from List A. After this "delayed recall" task, a list of 50 words is presented containing all of the words from Lists A. The score given for each trial is the total number of words recalled. Normal scores are 6 words hit on the first trial and 12 or 13 on the fifth trial.
Change in the memory over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via the memory failures of every-day (MFE)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The Memory Failures of Everyday-MFE Questionnaire was used for the subjective assessment of memory. It consists of 28 items on situations and activities of daily living. Each item was scored on a 0-2 point scale ("never or rarely", "sometimes", "many times").
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.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The ACE-R takes between 12 and 20 min (average 16) to administer and score in a clinical setting. It contains 5 sub-scores, each one representing one cognitive domain: attention/orientation (18 points), memory (26 points), fluency (14 points), language (26 points) and visuospatial (16 points). ACE-R maximum score is 100, composed by the addition of the all domains
Change in the overall memory over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) assessed during Digit Span (WAIS-III): Forward.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The Digit Span score is the length of the longest correctly repeated sequence. The idea was to test how much a person can receive, process and remember for a variety of elements. On average a person is not capable of retaining more than 7 pieces of information. This means that when the longest repeated sequence is 7, the participant reached level 7. The test was assessed in forward orders of the digits.
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.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Throughout the Stroop test, a total of three different tasks are carried out, through three sheets in which five columns of 20 elements appear. Each one of the tasks is carried out during a certain time (for example, forty-five seconds), scoring the successes for later evaluation. The successes that the subject has had during the test or the time it takes to react to the stimulation are valued, paying attention to what is reflected in each of the sheets or tasks.
Changes in the expression of language over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Boston Nomination Test.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The Boston vocabulary test consists of 60 figures, ordered from the easiest to the most difficult. The figures are presented in order, allowing the subject 20 seconds to respond. The scores provided by the test are: - The number of correct answers given spontaneously.
Changes in the expression of language over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via semantic Verbal Fluency test.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The Semantic Verbal Fluency (SVF) test entails the generation of words from a given category within a pre-set time of 60 seconds.
Changes in sleep behaviors over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via The Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The Pittsburgh Sleep Quality Index (PSQI) is the most widely used sleep questionnaire in adults, consisting of 24 questions. The first 19 questions are answered by the evaluated person taking into account what they have experienced during the last month. Resultados de traducción Sleep quality index (PSQI)
Changes in concussion over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via king figure method.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Demonstration and test cards for the King-Devick test, a candidate rapid sideline screening for concussion based on speed of rapid number naming. To perform the King-Devick test, participants are asked to read the numbers on each card from left to right as quickly as possible, but without making any errors. Following completion of the demonstration card (upper left), subjects are then asked to read each of the three test cards in the same manner. The times required to complete each card are recorded in seconds using a stopwatch. The sum of the three test card time scores constitutes the summary score for the entire test, the King-Devick time score. Numbers of errors made in reading the test cards are also recorded; misspeaks on numbers are recorded as errors only if the subject does not immediately correct the mistake before going on to the next number.
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).
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The QOD-NS questionnaire consists of 17 negative statements about the degree to which patients suffered from olfactory impairment. Patients can agree, partly agree, partly disagree, or disagree in each statement which ranges from 0 to 3. A total score of 0-51 is calculated with higher scores reflecting worse olfactory-specific quality of life. For the sQOD-NS questionnaire composed of 7 items, the total scores range from 0 to 21.
Changes in dyspnea scale over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via modified Medical Research Council (mMRC) dyspnoea scale.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing.
Change in scale of Asthenia over time-point (baseline, 4 weeks, 8 weeks, 12 weeks) via asthenia scale.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Analog scale from 0 to 100 mm
Change in Fatigue scale over time-point (baseline, 4 weeks, 8 weeks, 12 weeks) via Krupp Clader CFQ-11 Fatigue Intensity Scale.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The Chalder Fatigue Questionnaire (CFQ) also referred to as the Chalder Fatigue Scale, is an 11-item questionnaire measuring the severity of physical and mental fatigue on two separate subscales. Seven items represent physical fatigue (items 1-7) and 4 represent mental fatigue (items 8-11). Each item is scored 0-3; less than usual (0), no more than usual (1), more than usual (2) and much more than usual (3). The ratings of items are added together to calculate the total score (range=0-33). High scores represent high levels of fatigue.
Change in Emotions scale over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Brackets RULER scale.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Brackets' RULER syllabus consists of five key skills, which anyone can learn. The acronym "RULER" stands for Recognize, Understand, Label, Express, and Regulate. The first three skills allow us to practice identifying our emotions. The last two allow us to develop the necessary skills to deal with them. The RULER curriculum is about gathering information by recognizing and understanding emotions. Apply emotional intelligence to various situations.

4 secondary outcomes

Change of Von Willebrand Factor over time-points (baseline, 4 weeks, 12 weeks, 12 weeks) via blood sample.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change of D Dimer over time-points (baseline, 4 weeks, 12 weeks, 12 weeks) via blood sample.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change of HS-CRP over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via blood sample.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change of Ferritin over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via blood sample.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

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 28 Feb 2023.
Background: PubMed 33357467Gorna R, MacDermott N, Rayner C, O'Hara M, Evans S, Agyen L, Nutland W, Rogers N, Hastie C. Long COVID guidelines need to reflect lived experience. Lancet. 2021 Feb 6;397(10273):455-457. doi: 10.1016/S0140-6736(20)32705-7. Epub 2020 Dec 23. No abstract available.
Background: PubMed 34108700Marshall M. The four most urgent questions about long COVID. Nature. 2021 Jun;594(7862):168-170. doi: 10.1038/d41586-021-01511-z. No abstract available.
Background: PubMed 33555768COVID-19 rapid guideline: managing the long-term effects of COVID-19. London: National Institute for Health and Care Excellence (NICE); 2024 Jan 25. Available from http://www.ncbi.nlm.nih.gov/books/NBK567261/
BackgroundS.E. de M.G. y de F. (SEMG), Guía clínica para la atención al paciente long COVID/COVID persistente, (2021) 1-12
Background: PubMed 33892403Raveendran AV, Jayadevan R, Sashidharan S. Long COVID: An overview. Diabetes Metab Syndr. 2021 May-Jun;15(3):869-875. doi: 10.1016/j.dsx.2021.04.007. Epub 2021 Apr 20.
Background: PubMed 32475821Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31.
BackgroundD. Barron, Bringing the Clinical Trial to the Patient, Eye Pharma. (2017)
Background: PubMed 34064550Rubilar T, Barbieri ES, Gazquez A, Avaro M. Sea Urchin Pigments: Echinochrome A and Its Potential Implication in the Cytokine Storm Syndrome. Mar Drugs. 2021 May 11;19(5):267. doi: 10.3390/md19050267.
Background: PubMed 32429179Artyukov AA, Zelepuga EA, Bogdanovich LN, Lupach NM, Novikov VL, Rutckova TA, Kozlovskaya EP. Marine Polyhydroxynaphthoquinone, Echinochrome A: Prevention of Atherosclerotic Inflammation and Probable Molecular Targets. J Clin Med. 2020 May 15;9(5):1494. doi: 10.3390/jcm9051494.
Background: PubMed 32895219Nabavi N. Long covid: How to define it and how to manage it. BMJ. 2020 Sep 7;370:m3489. doi: 10.1136/bmj.m3489. No abstract available.
Background: PubMed 33055076Mahase E. Long covid could be four different syndromes, review suggests. BMJ. 2020 Oct 14;371:m3981. doi: 10.1136/bmj.m3981. No abstract available.
Background: PubMed 33541867Altmann DM, Boyton RJ. Decoding the unknowns in long covid. BMJ. 2021 Feb 4;372:n132. doi: 10.1136/bmj.n132. No abstract available.
Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication

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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.

Tamara Rubilar, PhD principal investigator

Universidad Nacional de la Patagonia San Juan Bosco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Echinochrome A in people with Long COVID, run by Fernando Saldarini at 1 site in Argentina.

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 5 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: finished, as of the sponsor's last update on 28 Feb 2023. 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 Argentina. 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?

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 of symptoms over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) during rutine medical checkup. (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks). The study lists 25 primary outcomes in all. 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 NCT05531019, which also lists 21 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 28 Feb 2023.