COVID-19 Sequelae: Treatment and Monitoring. A Dietary Supplement Based on Sea Urchin Eggs With Echinochroma A
NCT05531019, Not applicable, Completed, Fernando Saldarini
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | COVID-19 Sequelae: Treatment and Monitoring. A Dietary Supplement Based on Sea Urchin Eggs With Echinochroma A | ClinicalTrials.gov |
| NCT number | NCT05531019 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 54 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Fernando Saldarini | ClinicalTrials.gov |
| Conditions | Long COVID | ClinicalTrials.gov |
| Interventions | Echinochrome A, Control | ClinicalTrials.gov |
| First posted | 2022-09-07 | ClinicalTrials.gov |
| Last updated | 2023-02-28 | ClinicalTrials.gov |
Registered outcomes 32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change of symptoms over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) during rutine medical checkup. | Baseline, 4 weeks, 8 weeks, 12 weeks | Measuring the symptoms as presence o absence of chest pain, cough, headache, sleep disorders, dysgeusia, myalgia, arthralgia. | ClinicalTrials.gov |
| Primary | Change of lung capacity over four times (baseline, 4 weeks, 8 weeks, 12 weeks) assessed during spirometry. | 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. | ClinicalTrials.gov |
| Primary | Change of walking distance during a six minutes walk test (6MWT) over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) | 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. | ClinicalTrials.gov |
| Primary | Change of depression measured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via the Beck Health Questionnaire. | 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. | ClinicalTrials.gov |
| Primary | 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). | 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) | ClinicalTrials.gov |
| Primary | Presence or absence of Myocarditis meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via electrocardiogram. | Baseline, 4 weeks, 8 weeks, 12 weeks | Electrocardiographic signs in patients with myocarditis include T-wave and ST-segment abnormalities, ST-segment elevation | ClinicalTrials.gov |
| Primary | Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Trial Making test (TMT). | 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. | ClinicalTrials.gov |
| Primary | Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Phonological verbal fluency test. | 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. | ClinicalTrials.gov |
| Primary | Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Frontal assessment battery (FAB). | 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. | ClinicalTrials.gov |
| Primary | Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via clock test (CDT). | 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. | ClinicalTrials.gov |
| Primary | Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Analogies (WAIS-III). | 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. | ClinicalTrials.gov |
| Primary | Change in the memory over time-points ) baseline, 4 weeks, 8 weeks, 12 weeks) via Rey Auditory Verbal Learning Test. | 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. | ClinicalTrials.gov |
| Primary | Change in the memory over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via the memory failures of every-day (MFE) | 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"). | ClinicalTrials.gov |
| Primary | 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. | 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 | ClinicalTrials.gov |
| Primary | Change in the overall memory over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) assessed during Digit Span (WAIS-III): Forward. | 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. | ClinicalTrials.gov |
| Primary | 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. | 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. | ClinicalTrials.gov |
| Primary | Changes in the expression of language over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Boston Nomination Test. | 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. | ClinicalTrials.gov |
| Primary | Changes in the expression of language over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via semantic Verbal Fluency test. | 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. | ClinicalTrials.gov |
| Primary | Changes in sleep behaviors over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via The Pittsburgh Sleep Quality Index (PSQI) | 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) | ClinicalTrials.gov |
| Primary | Changes in concussion over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via king figure method. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 11
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Go/No-Go Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)