Clinical Study on influence of ArtemiC Support®

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Name and any unique identifier of the trial:	Clinical Study on the Influence of ArtemiC Support® in patients with Long COVID
Primary endpoint(s):	Functional status, according to Post-COVID Functional Scale (PCFS) one, two, three and six weeks after treatment initiation.
Secondary endpoints:	Symptomatology according to the 10-point Likert scale one, two, three and 6 weeks after treatment initiation. Symptoms measured will be: 1. Dyspnea 2. Cough 3. Asthenia 4. Anosmia 5. Ageusia 6. Headache 7. Mental confusion
Blinding status:	N/A
Product status:	Each participant will be provided with two 30 ml jars of ArtemiC Support. The Sponsor will provide the Food Supplement free of charge for patients. Each treatment will be identified with a unique code. The medication sent to the centres, dispensation, return and destruction will be collected in the correspondent registers. Responsibility for production and supply, is with Swiss PharmaCan AG with a Responsible Person in place.
Treatment method, route, frequency, dose levels:	Study Product: Arm 1: ArtemiC Support: The active compounds in ArtemiC Support are Boswellia serrata, Curcuma longa and Vitamin C and uses the drug delivery system to increase bioavailability. Study Procedures: The collection of data will be done by in person interviews (mandatory at first assessment) and by in person interviews or phone calls after one, two, three or six weeks. Day one (1) is the day of first intake. On the day of inclusion and first assessment, the investigator will carefully explain the aim and the design of the study and handover a relevant information sheet. Data will be collected by healthcare professionals, either nurses or medics. Only medical doctors to sign up the relevant documents. Any side effects, possibly related to the intake of ArtemiC Support, will be carefully documented and reported as appropriate, in line with GCP vigilance rules. The statistical analysis will be descriptive. Description will be made for the change in scale, based on the PCFS questionnaire, comparing average scales on day of inclusion with those after one, two, three and six weeks, as well as the subgroups Scale 1, Scale 2, Scale 3 and Scale 4 on day of inclusion with those after one, two, three and six weeks. Methodology: Low intervention, single arm open study of 150 patients who suffer from post-acute COVID Syndrome. It is the investigator's responsibility to detect and document any event that meets the criteria and definitions of an Adverse Event (AE). It is also the responsibility of the investigator to report all Adverse Events that are considered serious. The AEs will be collected through spontaneous communication of the patient, and at every interview through an open questioning by the investigator. Information about the AE, including start and end date, description of the event, security, evolution, outcome, relationship of the AE with the food supplement and measures taken will be recorded in the Case Report Form. Participants AE/Adverse Reactions (AR) will be followed up during the remaining visits until the end of the study. The causal relationship between the investigational product and the appearance of an Adverse Event/ Serious Adverse Event (SAR) will be established, based on clinical judgment. For this, other causes will be considered and studied, such as the natural history of the underlying diseases, concomitant treatment, other risk factors and the temporal relationship of the event with the investigational product.
Number of trial subjects:	Total of 150 patients in Spain who suffer from post-acute COVID Syndrome (Long COVID Syndrome).
Description of Control Group:	N/A
Subject selection criteria:	Inclusion Criteria: · Age 18 - 80 years · Suffering from post-acute COVID Syndrome · Persisting post-acute COVID syndrome symptomatology of more than one month, with Post Covid Functional Score (PCFS) between one and four. · The patient must be able to complete the follow-up assessments. · The patient agrees to participate in the study and to take the assigned medication during the 6 weeks. · The patient signs the informed consent Exclusion Criteria: • Known hypersensitivity to ArtemiC Support · Active malignancy · Current or recent chemotherapy treatment (<6 months) · Medical history of Human Immunodeficiency Virus (HIV) infection, or any serious immunocompromised state · Use of montelukast or zafirlukast ≤ 30 days previous to the inclusion · Having participated in another clinical trial in the previous month
Trial locations:	Spain
Name of the principal investigator:	Dr. Carlos Brotons
Partners:	Swiss PharmaCan AG, Glow LifeTech Ltd, MGC Pharmaceuticals Ltd, Universal Doctor and EAP Sardenya
Expected duration:	The Trial commenced on 10 December 2021 and is expected to conclude in March 2022
Additional information:	N/A
Trial standard:	The clinical study follows the principles of the Declaration of Helsinki, the ICH harmonized tripartite guideline for Good Clinical Practice (GCP) and the current legal norm in Spain (Real Decreto 1090/2015, 4 December)

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