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.
Phase: NA
Conditions: Long COVID
Sponsor: Fernando Saldarini

 
Cover Letter 
 
ClinicalTrial.gov 
 
Here by we present the data from the Clinical Trial that it is being 
carrying out in Argentina using a Dietary Supplement based on sea 
urchin eggs with Echinochrome A. 
 
We present the formal Information, Protocol and Informed Consent in 
this Document. 
  
Formal Information: 
 
Clinical Trial at Hospital Santojanni in Argentina 
Approved by Ethic Committee of the Hospital  
Approval´s Number: 5832 
Date of approval:  September 22th of 2021 
Title: COVID-19 Sequelae: Treatment and Monitoring. A Dietary 
Supplement Based on Sea Urchin Eggs With Echinochroma A 
Support by a Grant from the Ministry of Science, Technology and 
Innovation of Argentina. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
PROTOCOL 
COVID-19 Sequelae: Treatment and Monitoring. A Dietary Supplement 
Based on Sea Urchin Eggs With Echinochroma A 
INTRODUCTION 
It is estimated that 20% of patients hospitalized for COVID-19 will have persistent symptoms 
after 5 weeks and 10% after 12 weeks. However, in non-hospitalized patients it was found that 
between 32.6% and 87.4% present at least one persistent symptom after months of having 
suffered from COVID-19. To signs and symptoms that began during COVID-19 infection or after 
her, and last beyond 12 weeks from the date of onset of symptoms, and not can be explained 
by alternative diagnosis is called persistent COVID. The The importance of this syndrome was 
warned by the WHO on October 30, 2020 by its Director General due to the number of people 
with this condition and the effects on their health. However, it only physical symptoms are 
considered and the mental health of patients is not included, although addressing this 
appearance is an integral part of your ref health. Being multisystemic, this syndrome requires an 
approach multidisciplinary, capable of studying physical, cognitive, psychological and social 
aspects. So far, it is known that persistent COVID syndrome can have disabling consequences for 
prolonged periods. These sequelae can involve a wide variety of symptoms, from extreme 
fatigue, muscle and joint pain, shortness of breath, palpitations, loss permanent loss of taste and 
smell, gastrointestinal upset, and problems with attention, memory, and cognition. However, 
the exhaustive understanding of the syndrome, its monitoring and the search for treatments 
singles have not yet been determined. The Decentralized Medical Trials Manual of the 
Association of Research Organizations Clinic (ACRO) recommends decentralized medical testing 
or partially decentralized, organized around the patient. Decentralization refers to monitoring 
of patients from their place of residence to prevent them from going to health centers in regular 
way. The decentralization can be total or partial depending on whether during the treatment they 
never go to a health center or do so occasionally. These types of studies can be carried out 
through the use of telemedicine and artificial intelligence tools, the use of remote visits and visits 
to the patient's home to carry out the collection of biological samples necessary for carry out the 
study. On the other hand, the design around the patient is intended to be friendly and allow the 
patient's perspective to be at the heart of the study, considering the patient's well-being from a 
comprehensive perspective (clinical and psychological). This approach allows the patient to 
know their perspective of physical and emotional health and feel accompanied throughout the 
clinical study, which improves patient adherence to the clinical trial. There are no specific 
treatments yet for persistent COVID syndrome, and given the range of symptoms persistent, 
treatments should focus on generating a systemic improvement of the patient, especially for 
improve her quality of life. Echinochroma A (EchA) is a pigment derived from sea urchins which 
is known for its antioxidant power and its proven benefits for human health, especially heart 
disease and inflammatory pathologies. Oral administration of EchA in patients with syndrome 
Persistent COVID can bring many benefits: reduced inflammation, elimination of ROS and the 
induction of glutathione (GSH) pathways, among the most prominent. Also, due to the 
pharmacological activities of EchA, its low level of toxicity and high bioavailability, is 
hypothesized which will contribute highly positive clinical benefits to patients with sequalae 
from COVID. Therefore, the objective of this project is to carry out a partially decentralized study 
around the patient with COVID-19 sequalae from a multidisciplinary perspective, with an 
intervention when administering a Dietary supplement based on sea urchin roe rich in 
Echinochrome A. 

Objectives and Hypothesis 
1 To perform an outpatient treatment with a Dietary supplement based on sea urchin roe rich 
in Echinochrome A in patients with sequalae from COVID-19. 
a - H1-1: The Dietary supplement improves the clinical status of patients with COVID-19 sequelae 
Justification: Treatment with the Dietary supplement rich in Echinochrome A is expected to 
activate the metabolism of glutathione, improves the functioning of the mitochondria, 
decreasing the cellular oxidation state and general inflammation of the endothelium, generating 
an improvement in the clinical status of patients and reducing your recovery time. 
b - H1-2: The Dietary supplement based on sea urchin roe rich in Echinochrome A reduces the 
recovery time of patients with sequelae from COVID-19 
Justification: Treatment with the Dietary supplement by activating the metabolism of 
glutathione and decrease cell oxidation and inflammation of the endothelium, reduces recovery 
time of the patient. 
2 Perform a multidisciplinary follow-up of the evolution of the patient with COVID sequalae, 
involving clinicians, pulmonologists, neurologists, counselors, biochemists and Researchers. 
a - H2-1: The multidisciplinary approach allows a deep understanding of the symptoms of the 
sequalae from COVID and its evolution 
Justification: This approach will allow for a comprehensive analysis. Can be tracked simultaneous 
clinical, neurological, neurological, cardiological, psychological, biochemical approach, with a 
adequate analysis of the data, allowing a deeper understanding of the symptoms. 
b - H2-2: The multidisciplinary approach generates high adherence to the study and allows a 
emotional accompaniment of patients, improving their mood Justification: the multidisciplinary 
approach will allow comprehensive monitoring of patients and increase knowledge about the 
persistent symptoms found in the patients with sequalae from COVID-19. In addition, 
psychological support will increase the patient's adherence to treatment and will improve your 
emotional state when accompanied. 
3 Follow up with patients on a daily basis using a partially decentralized through the use of 
telemedicine in patients with the COVID sequalae. 
a - H3-1: The partially decentralized approach by telemedicine allows a daily follow-up of the 
symptoms of patients with sequalae from COVID, thus relieving the health system 
Justification: Daily telemedicine follow-up will decrease the frequency with which patients 
approach or communicate with doctors, relieving the daily tasks of health personnel and 
administrative work that normally involves a medical test, obtaining high-quality data anyway. 
b - H3-2: The partially decentralized by telemedicine allows the emotional accompaniment of 
the patients increasing their adherence to the study and improving their mood and emotional 
state. 
Justification: The decentralized design is focused on the well-being of the patient, providing a 
daily accompaniment by telemedicine and emotional weekly. In addition, patients can 
Communicate through the telemedicine system in case of doubts or concerns, providing greater 

security. As well as they will be able to have access when requesting it of their progress to be 
able to understand how they evolve the consequences. 
 
 
Partially decentralized design focused on the patient. 
It is proposed to make a partially decentralized design around the patient following the ACRO 
recommendations. These studies use digital technologies to optimize resources of the health 
system and to allow the patient to have daily contact with the objective to accelerate the 
production of results and create an efficient dynamic of the research process. This type of design 
puts the patient at the heart of interactions and allows for more efficient bonding of all the 
actors involved. In this case, the patient with symptoms of persistent Covid-19 is detected in the 
Hospitals, the treatment is offered to the patient according to medical criteria, the patient's file 
is filled out with the clinical history and through informed consent, the participant is recruited 
in this comprehensive care model with intervention. We proceed to complete the Digital Entry 
Form of the patient where their data is uploaded and a photo of the informed consent document 
is attached signed, the group of CONICET-UNPSJB Researchers receives the information about 
the patient and by randomized algorithm, the delivery of the nutraceutical or the placebo is 
determined and sent to the patient's address along with pertinent information. The ID of each 
patient in the entire Health System telemedicine will be your ID. Once loaded, the link of the 
digital self-tests will be sent to your WhatsApp designed for this study, which the patient must 
complete and send daily as a health report and you can use it whenever she needs it. SKYMED 
is governed by Law 25,326 on Data Protection Personal and Law 26,529 of the Right of the 
Patient and has the due Confidentiality Agreements that protect and commit all parties in your 
application during the use of the platform. Starting from that moment the Muñiz Hospital 
Hemostasis Team and the Team of Psychological Consultants Receive patient information. From 
here, through the calendar of the telemedicine system SKYMED organizes shifts for each patient 
with Hospital Muñiz for blood collection, interviews with the psychological accompaniment and 
the medical follow-ups by the different doctors and hospitals involved. The patient fills out the 
form every day and this information can be monitored instantly. If the patient has symptoms 
that show deterioration, sends an alert to the medical team through the triage system that 
SKYMED has based on artificial intelligence. The patient has an instant messaging interface to 
make inquiries during the treatment in addition to the weekly interviews with the team of 
psychological consultants and the Monthly visits to hospitals. The evolution of the patient is 
carried out weekly and at the end of the study the results are already very advanced to be able 
to conclude on them. This approach seeks to accompany the patient throughout the medical 
study from a multidisciplinary, considering the practical aspect of decentralization with the 
emotional care that patients with persistent COVID syndrome require. 
The SKYMED telemedicine system has been used successfully for a year in Chubut (Lago Puelo) 
and uses the key performance indicators (KPIs) established by the WHO for the care of COVID- 
19, in order for the doctor to evaluate the patients, and, with the help of the artificial intelligence 
digital technology, early detection of symptoms that are considered within a serious picture to 
send alerts to the health system. For this particular study, it was adapted the system with a 
design and interface or dashboard based on the KPIs specified by the team medical, scientific 
and psychological consultants, for the monitoring of the participants, the collection and data 
processing, and immediate accessibility to the results in the interface on a cell phone, tablet or 
PC of patients with COVID-19 sequalae. Since there are very few scales around the patient that 
adequately reflect the clinical situation of patients with sequalae from COVID-19 and that 

evaluates its evolution in a comprehensive way to integrate symptom monitoring so that in- 
depth symptom assessment is possible; It will be used a brief and easy-to-use self-report 
questionnaire that will consist of different scales to perform a comprehensive assessment and 
can be used for repeated measurements over time to monitor the progress. The scales were 
selected according to the recommendations of Sanz Almazán et al (2021), who analyzed which 
would be the most appropriate scales to assess persistent symptoms that found in the persistent 
COVID syndrome, as well as its limitations and possible improvements. So daily clinical data will 
be evaluated. The questionnaire that assesses mood will have a psychoeducational functionality 
in itself since it will provide self-exploration and self-management tools emotional that will be 
answered 2 times a week. 
In SKYMED, the patient completes the entire questionnaire at the indicated frequency. The 
system sends reminders to take the surveys at different times of the day and/or week to ensure 
your compliance. In turn, doctors, psychological and biochemical consultants can upload the 
information that they collect per patient. The scientists of the team will carry out the analyzes 
on a weekly basis during the study as the data is collected by the SKYMED system. The final 
report will be once the study is completed. 
The psychological accompaniment will be carried out through a weekly virtual Zoom meeting of 
30 minutes during the three months of treatment with the psychological consultant, in which he 
will be given accompaniment and emotional support hoping to sustain their adherence to it 
(Centered Approach in the Person. Likewise, face-to-face evaluations will be carried out with 
specialist doctors, at the beginning of the medical test and once a month after beginning the 
treatment, until its completion. In these evaluations will carry out a complete clinical and 
psychological study. Face-to-face evaluations are also carried out with the specialists, at the 
beginning of the medical test and once a month after starting the treatment, until its 
completion. In these evaluations, a complete clinical study will be carried out, evaluating the 
presence of cough, chest pain, dyspnea by mMRC scale, quality of life by EuroQOL scale, 
spirometry will be performed (FVC, FEV1, FEV1/FVC), the walk test of 6 minutes, a HRCT of the 
Chest, an electrocardiogram, the evaluation of fatigue measured with the MFI scale, the 
cognitive evaluation will be carried out with the MMSE (minimental State) scale, ACE-R 
(Addenbrooke's Cognitive Examination), attention by San of Digits forward, Digits and signs 
(WAIS-III), Trial Making A and Stroop Test; executive function with Trial Making B, word 
generation (phonological verbal fluency), FAB (Frontal Assessment Battery), clock test (on 
command) and analogies (WAIS-III); Language will be evaluated with the Boston Nomination 
Test and through semantic verbal fluency; Verbal Memory will be evaluated by the RAVLT test 
(Rey auditory verbal learning test), Visual Memory with the Rey Figure (evocation and 
recognition), Visuospatial ability with the Rey Figure (copy) and the clock test (Copy) and Mood 
assessment with the Beck Inventory. Finally, blood samples will be taken from the patients to 
perform a complete blood count, platelets, white blood cells and formula in absolute and 
relative values, C-Reactive Protein, Ferritin, D-Dimer and Von Willebrand Factor. 
 
 
SKYMED telemedicine 
The telemedicine System and Remote Patient Control SKYMED complies with the quality 
standards established in the Design Quality Manual for ACRO Decentralized Clinical Trials 
(Association of Clinical Research Organizations for its acronym in English), regarding the 
possibility of entering data by the patient and the equipment intervening remotely, as well as 

that the system is subject to the laws and regulations of data protection and privacy that 
regulate these types of data released. It also meets the Total Quality Control standards, having 
been tested with constant improvement in use for 13 months for COVID-19 control, providing 
connectivity and solid infrastructure because it ensures the integrity and security of electronic 
records, accuracy and precision of measurements, technological solutions are fit for purpose. In 
addition, a user manual is provided where the flow and collection of data is described, it has 
backup backup of the entire system, storage, filing and availability for retrieval of source 
documents and information electronics during and after the test. On the other hand, there is a 
management plan in case of failure for all the parties, they are trained to use the system and 
adequate support is provided to all parties, articulating the investigators in a clear manner the 
procedures for decentralized clinical trials, it is added efficiency, cost savings by reducing waste 
and contributes to reducing climate change. The risk is minimized because: users are restricted 
with the use of unique and non-transferable credentials for entry into the system; there is no 
resistance to change because users and participants are willing to the use already proven in 
effectiveness of SKYMED, interfaces of known use and easy access are used, and alternative 
plans exist if a participant is unable to access for any reason; assistance is provided permanent 
technique to ensure effectiveness in the design of the system infrastructure; the system has 
optimal technological interoperability and data integration; constant training is given to new 
processes to all users; the best security standard is provided with the best provider 
technological; there is an optimal governance structure; It has a large data loading space that 
prevents system overload; SKYMED lowers costs and provides efficiency in studies focused on 
the patient minimizing the administrative work of the evaluation team and providing access to 
information processed and reliable for strategic decision making 24 hours a day, 7 days a week. 
 
 
Ethical and environmental safeguard 
This research project will not affect human rights nor will it be the cause of any eventual damage 
to the environment, animals and/or future generations. All work done previously carried out in 
compliance with the Biosafety and Environmental Safety Standards in force, so its realization will 
not have any impact on the environment. Biological material (blood samples human) will be 
processed in a biological safety cabinet and all the elements and reagents used properly 
discarded following the standards indicated by the Health and Safety Committee of the Hospital 
F. J. Muñiz. In this sense, the Hospital has a pathological waste management service. On the 
other hand, the methodology included in this project has been endorsed by the Ethics 
Committees of the hospitals. 
Physicians will invite patients and/or their immediate family members to participate in the 
research study, explaining in a detailed and understandable way the characteristics of the study 
and future studies related to sequelae in COVID-19. Informed consents are approved by the 
Committees of Ethics and/or Teaching and Research of the Hospitals involved. In Argentina there 
is a law that protects personal information (Law No. 25,326 on Data Protection Personal) that 
establishes the integral safeguard of data settled in files or records, be they public or private, to 
guarantee the right to honor and privacy of people. When is made reference to "Client's personal 
data" is about the personal data of which the Institutions authorized are controllers and that 
OcusCloud processes in the course of providing the SaaS (Software as a service) SkyMeD. The 
terms "controller", "processor", "process", "processed", processing" and "personal data" used, 
are defined according to the Union Directive 95/46/EC European Union, except as defined by 
the corresponding data protection legislation. OcusCloud guarantees under the 

clauses of a confidentiality agreement, in all media / systems that are under its control and 
guardianship, the implementation of the technical and organizational measures that are 
necessary to protect the data provided. There is also Law 26,529 of the Right of the Patient, in 
force since February 2010, which regulates the civil relations between the patient with the 
doctors and with the institutions of Health and legislates on the information that the doctor 
must give and that the patient must receive regarding clinical documentation. The information 
and clinical documentation of the patient has the due protection of its privacy and the 
confidentiality of its sensitive data. This includes the statistical secrecy, in relation to the 
development of databases in the health system, by which the statements and/or individual 
information may not be communicated to third parties or used, disseminated or published in 
such a way as to allow the person or entities to be identified. sensitive data related to the patient 
are protected by confidentiality and privacy as well as by the data from the investigation. Only 
researchers will have access to this information directly related to the trial and the members of 
the Teaching and Research Committees and/or Hospital Ethics. All adverse effects will be 
reported to the Ethics Committees instantly according to current national laws, whether or not 
associated with the administered product. The researchers participating in this project know and 
carry out the safeguards provided for in all ethical, legal and legal requirements, established in the 
National bioethical standards -ANMAT provision 5330/97- and International -Nuremberg Code, 
declaration of Helsinski version 2008 and its modifications, universal declaration on the human 
genome and human rights approved by the General Conference of UNESCO 2005 and according 
to the regulations of the International Declaration on the human genetic data UNESCO 2003, the 
Universal Declaration on Bioethics and guidance for Human Health Research (GISH), resolution 
1480/2011 MSN. The counselors involved they know and follow the rules of the Professional 
Code of Ethics of the Argentine Association of Counseling. 

INFORMATION FOR THE PARTICIPANT AND WRITTEN INFORMED 
CONSENT FORM 
 
 
COVID-19 Sequelae: Treatment and Monitoring. A Dietary Supplement Based on Sea 
Urchin Eggs With Echinochroma A. 
 
Location: Hospital Santojanni. 
 
 
Responsible MD: Dr. Fernando Saldarini 
 
 
Telephone: 011 3703-0712 
Address: Pilar 950, Buenos Aires 
 
 
 
Dear Participant 
You have been invited to participate in a basic science research study where you 
want to study that Echinochroma A extracted from sea urchin roe alleviates the 
symptoms of COVID 19 with comorbidities. This research is different from 
healthcare practice, however, it is combined with it as we will use your clinical data 
obtained from healthcare for this research work. Before deciding whether or not to 
take part, it is important for you to know why the study is being done and what it 
will involve. Please take some time to read this information. If you wish, discuss this 
with family members, friends, your personal doctor, or your study doctor. Please 
ask if anything is not clear or if you would like more information. 
 
 
Why is this study being done? 
The SARS-CoV-2 virus caused the COVID-19 pandemic very quickly. This virus is new, 
highly contagious and has caused almost 3 million deaths globally to date, especially 
patients with comorbidities. The pathogenesis produced by the viral infection caused by 
SARS-CoV-2 in humans is still unclear and there is no effective treatment to prevent 
contagion or treat the disease. In severe cases, the virus induces the Cytokine Storm 
Syndrome characterized by the massive release of cytokines, being the main cause of 
death among patients infected with COVID-19. During the Cytokine Storm, pro- 
inflammatory cytokines are released in excess, resulting in overwhelming systemic 
inflammation, hemodynamic instability, multi-organ dysfunction, sepsis, fever, 
hyperferritinemia, and, in many cases, death. COVID-19 patients with pre-existing 
comorbidities may present with Cytokine Storm and coagulopathies that may progress to 
a severe stage. Therefore, the objective of this study is to be able to provide a nutraceutical 
to patients on an outpatient basis that prevents cases from getting worse and having to be 
hospitalized in the health system. Thus obtaining two results simultaneously: the benefit 
to the person and the health system. Having already spent more than a year since the start 

of the pandemic, facing an imminent second wave and with the precarious health system 
in our province and extremely in demand; We hope that our development from the 
scientific system and with the accompaniment of the private sector can be beneficial. 
 
 
Who can participate in this study? 
 
 
Persons over 18 years of age with a positive diagnosis of COVID-19 determined by PCR 
or other commercial or public health assay in any sample and have one with comorbidity 
 
 
What does this study include? 
If you choose to participate, you will need to fill in your details in the SkyMed 
Telemedicine System. The data that will be requested to start is sex, age, weight, 
comorbidity and contact data. A blood sample will be obtained to study the concentration 
of the CR protein, proinflammatory cytokines IL-6 and TNF-α, total peroxidase activity, 
total oxidant activity, free radicals in plasma, the proportion of CD95+ and the HLA-DR 
antigen. The SkyMed System is governed by Law 25,326 on the Protection of Personal 
Data and Law 26,529 on the Right of the Patient. 
 
 
What is being investigated to help people with covid 19 with comorbidity? 
The purpose of this study is to test whether Echinochroma A can be used in the treatment 
of COVID-19 to relieve symptoms in patients with comorbidities. The information 
obtained from your data, including, does not imply that it has direct relevance to you or 
your family, since it is an investigation that must be repeated before drawing definitive 
conclusions. However, it can be useful in the course of the disease. 
 
 
How many people will participate in this study? 
Approximately a number of not less than 70 people, with a diagnosis of COVID-19 and 
comorbidities. Half will be administered Echinochroma A and the other half a double- 
blind placebo. 
 
 
Are there any risks or discomforts involved? 
Pain or discomfort in drawing blood. In some cases, a hematoma may appear at the site 
of the blood draw. Some people feel faint when blood is drawn. 
 
 
Are there any benefits? 

This study could benefit your health status when you are infected with COVID-19. In 
addition, the fact of voluntarily participating in the study allows you to have access to the 
information on the results of the determinations that are made. Also, you have the right 
to decide not to be informed about your results. In both cases, you must inform SkyMed 
of your decision to know or not know about your results. 
 
 
Payment to participants / expenses / costs 
There will be no cost to you for any laboratory tests or procedures. You will not receive 
any payment for participating in this study. 
 
 
Funding source: 
Ministry of Science, Technology and Productive Innovation of the Argentine Nation. 
 
 
Voluntary participation/withdrawal from the study 
Your participation in this study is voluntary. If you decide to participate, you will be asked 
to sign the informed consent at the end of this document and keep a copy of it and this 
information sheet. You have the right not to participate. Likewise, you have the right to 
withdraw your consent at any stage of the investigation, without suffering any 
discrimination, penalty or prejudice. You must report through SkyMed if you decide to 
do this. Your decision not to participate in this study or to discontinue your participation 
in the study will not affect your current or future health care, or any other benefits to 
which you are entitled in any way. If you withdraw from the study, your data will not be 
used. The signing of this informed consent does not imply the loss of the rights that legally 
correspond to you according to the laws in force in Argentina. 
 
 
 
Confidentiality 
If you decide to participate in the study, you will be asked for personal information. For 
your security, in Argentina there is a law that protects this information (Law No. 25,326 
on the Protection of Personal Data). This Law also gives you the right to have access to 
all the data collected about you in the study. The doctors and staff of the study, as well as 
the Research Ethics Committee of the Hospital that reviewed this study, and the Research 
Ethics Committee of the MSGCBA may have access to your personal information if they 
consider it necessary and are obliged to respect the law that protects your personal 
information. In this written consent, it is stated that the data obtained will be handled with 
absolute confidentiality, with only the research team, the Teaching Committee and the 
Research Ethics Committee of the institution having access to them. In the event that the 
data is presented at congresses or published in national or international publications, the 
identity of each participant will be fully protected. The identification of the sample will 

only be possible to recognize by the principal investigator, since the sample is coded by 
encrypting it with the patient's initials and an internal reception number of the laboratory. 
 
 
Who should I contact with any questions? 
- If you wish to ask any questions related to the nature of the research during the study, 
please contact those responsible for the study through SkyMed. 
 
 
- If you have questions about your rights as a research subject or about your 
participation in the study, you can contact: Dr. Alejandra Oviedo. RESEARCH 
ETHICS COMMITTEE CEI SANTOJANNI, ceisantojanni@gmail.com, PHONE. 011 
46305848 

INFORMATION FOR THE PARTICIPANT AND WRITTEN INFORMED 
CONSENT FORM 
 
 
COVID-19 Sequelae: Treatment and Monitoring. A Dietary Supplement Based on Sea 
Urchin Eggs With Echinochroma A. 
 
Location: Hospital Santojanni. 
 
 
Responsible MD: Dr. Fernando Saldarini 
 
 
Telephone: 011 3703-0712 
Address: Pilar 950, Buenos Aires 
 
I declare that I have been invited to participate in the research study on COVID-19 
Sequelae: Treatment and Monitoring. A Dietary Supplement Based on Sea Urchin Eggs With 
Echinochroma A. 2.6 
 
 
I have received information from Dr/a… ............................................................. (name 
and surname) about this research study and I have been able to ask questions, which 
were answered satisfactorily. I have understood the information received from the 
research study. I understand that my participation is voluntary and that I can 
withdraw from the study at any time, without giving reasons, and without affecting 
the health care that I should receive if I do not participate or withdraw from the 
research study. I agree to participate in this research, keeping a copy of the 
information sheet and the informed consent form for myself. 
 
 
- Signature of the participant Name and surname: 
DNI Nº: 
Place and date: 
 
 
- Signature of the witness** Name and surname: 
DNI Nº: 
Place and date: 
 
 
- Signature of the researcher Name and surname: 
DNI Nº: 
Place and date: 

 
As Principal Investigator and/or collaborator of the study, I agree to comply with the 
approved protocol, Law 3301, its Regulatory Decree, and any other regulation related to 
the Research protocol, adjusting to the universally proclaimed and cited ethical values 
and principles. in this Law and to respect the rights of the subjects participating in this 
research study during the conduct of this study. 
 
 
 
** The witness must be present at the moment when the researcher and/or the person who 
obtains the informed consent explains its content to the participant. 
 
 
 
 
 
 
 
 
 
 
 
INFORMED CONSENT FOR THE PARTICIPANT IN THEIR MONITORING, SUPPORT 
AND EMOTIONAL SUPPORT BY A PSYCHOLOGICAL CONSULTANT 
 
 
COVID-19 Sequelae: Treatment and Monitoring. A Dietary Supplement Based on Sea 
Urchin Eggs With Echinochroma A. 
 
 
 
 
Name and Surname of the Participant Patient/Consultant: ………………………… 
DNI: …………………………… 
Contact cell phone: …………………… Third person contact information …………………. 
 
 
Please read this document carefully, it may contain phrases or words that you cannot 
understand. If so, please ask the treating professional to explain in detail any information that 
you do not clearly understand. By signing this document, you will be accepting its content and 
giving your consent to the conditions detailed here. 
 
 
 
Characteristics of Follow-up, Accompaniment and Emotional Containment 

Follow-up and accompaniment will be carried out with the orientation of the Person-Centered 
Approach from the Psychological Consultancy/Counseling for emotional support for 
psychoeducational purposes, prevention and promotion of the holistic well-being of the 
patient/consultant, as a joint work of the partially decentralized approach by telemedicine 
focused on the person who participates voluntarily and is selected for this study for being a 
patient with COVID-19 sequelae and aimed at attending to the reasons for consultation exposed. 
This agreement is between the patient involved in the study, hereinafter called Consultant and 
treating professional, hereinafter called Psychological Consultant. 
 
 
Duration and Modality in the Follow-up, Accompaniment and Emotional Containment Process 
1. The duration of the follow-up and accompaniment will be only and for the duration of the 
permanence of the consulting participant, in the present study (three months). The process is 
individual and will be developed within the framework of virtuality, using the SkyMed tool on 
the one hand, and the encrypted information videoconferencing platform/system (Zoom, Skype, 
Googlemeet) or messaging for personal use (WhatsApp on the other). /facetime). 
A-When you contact the Psychological Consultant for the first time, you will receive a 
WhatsApp message in response where you will be asked for additional consent for the use of 
the videoconference or video call 
B-Procedure in technological failures: The internet connection can be interrupted, both for the 
professional and for the patient/consultant. This circumstance is protocolized. Two scenarios 
can occur, mainly: 
• The connection suffers interruptions or is not fluid, so it will be agreed to keep the meeting 
through a phone call or re-schedule it in order to have optimal communication. 
• The connection is cut and it is not possible to resume it. You will be contacted by another 
means, audio or text, in order to notify that it is not possible to carry out the session and proceed 
to re-schedule it. 
2. The frequency of the meetings will be weekly. Its duration will be 30 minutes, and there may 
be variations depending on what happens during the meeting. 
3. The absence to 2 (two) consecutive meetings will be interpreted as an abandonment of the 
process. If you want to restart, you must contact SkyMed. 
 
 
Cancellation of the Meeting 
1. In order to maximize the effectiveness of care services, in follow-up, accompaniment 
and emotional support, I will make the listening space a high priority and I will not 
cancel meetings, except in cases of emergency. The Psychological Consultant lends his 
availability free of charge, please consider the commitment and valuation of this time 
informing of a possible cancellation of a meeting at least 24 hours in advance. If I 
connect late to a meeting, I understand that I will use only the time remaining in the 
scheduled meeting. 
 
Emergency 
1. Online meeting is not and does not cover emergency services. In the case of an 
emergency, I must dial the emergency number in my area, contact my doctor through 
SkyMed or go to the emergency room/call of any hospital closest to my place of 
residence. 

Payment of Fees 
1. Assistance is provided free of charge and I must not pay any monetary value to the 
professional Psychological Consultant. 
 
 
Privacy and Confidentiality 
1. Data related to follow-up care, accompaniment and emotional support follow the 
regulations mentioned above in the “INFORMATION FOR THE PARTICIPANT AND 
WRITTEN INFORMED CONSENT FORM”. 
 
Supervision – Co-vision 
1. In the event that some aspects of my professional care require the supervision of a 
supervising professional Psychological Consultant and/or Psychologist, you will be able to 
access my clinical history and personal information for treatment purposes, and I will be 
notified in advance. . 
 
 
Clinical History-Reports 
1. Through the SkyMed tool, I will complete a survey to provide information about my mood 
and emotional state during my participation in the study, and on the other hand, my 
Psychological Consultant may collect personal information about me to incorporate in my story 
clinic. 
2. The documentation must be kept in a safe place for a minimum of 5 to 10 years after the last 
date of contact to be designated by the regulations of the Investigation. 
 
 
Evolution of the Follow-up, Accompaniment and Emotional Containment Process 
1. The process may be unilaterally interrupted by the consultant at the time he/she deems 
appropriate, informing the professional of this decision, who will assess whether this 
interruption may be detrimental to himself or third parties, reserving the right to notify the 
professional. who he considers responsible. 
2. Confidentiality and due secrecy are guaranteed regarding the information received in 
professional practice, whose limit may only be violated for a just cause, in accordance with the 
provisions of the codes of ethics and current legal regulations, or before the possibility of harm 
to himself or third parties. 
3. The consultant undertakes to comply with the indications that the treating professional gives 
him, in the case of considering necessary a medical, psychological and/or psychiatric 
interconsultation or a referral to another institution. 
 
 
I hereby certify that: 
● All the personal data that I have provided for the preparation of the clinical history are true. 
● I have received sufficient information about the follow-up, accompaniment and emotional 
support that will be provided to me and I have understood all the requirements and conditions to 
carry it out. 
● That I have been informed of the administrative conditions regarding the payment of fees. 

 
- Signature of the participant Name and surname: 
DNI Nº: 
Place and date: 
 
 
- Signature of the witness** Name and surname: 
DNI Nº: 
Place and date: 
 
 
- Signature of the researcher Name and surname: 
DNI Nº: 
Place and date: