Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:49 PM
Study NCT ID:
NCT07418567
Status:
COMPLETED
Last Update Posted:
2026-02-18
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Fasting Pilot Study for Long COVID
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-12', 'size': 215984, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-02-10T14:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study includes a single arm'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fatigue severity score (FSS)', 'timeFrame': 'From baseline (day 0) to end of follow up at day 30', 'description': 'The Fatigue severity scale (FSS) (0-7 score, 7 being worse) is one of the tool to assess the severity of fatigue. It is validated for LC patients'}, {'measure': 'Cognitive failure questinonaire', 'timeFrame': 'From baseline (day 0) to end of follow up (day 30)', 'description': 'Assess cognitive impairment (25 questions, 0-100 score).Higher scores indicat increased propensity to cognitive impairment and it is validated for LC'}], 'primaryOutcomes': [{'measure': 'Feasibility and Acceptability', 'timeFrame': 'From baseline (day 0) to end of follow up day 30', 'description': 'Retention rates will be used to measure feasibility and response to Likert-like questions for measuring acceptability'}], 'secondaryOutcomes': [{'measure': 'Mean changes from baseline to one month post-fasting on the SF 36 physical component score questionnaire', 'timeFrame': 'From baseline (day 0) to the end of follow up at day 30', 'description': 'The SF 36 questionnaire is a validated scale for assessment and monitoring of patients with LC. The 36-item scale includes 8 subscales : role functioning-physical, body pain, general health, vitality, social functioning, role functioning-emotional, and mental health.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['long COVID', 'pilot clinical trial', 'Fasting'], 'conditions': ['Long COVID Syndrome']}, 'referencesModule': {'availIpds': [{'url': 'https://www.crchus.ca/accueil', 'type': 'Study Protocol', 'comment': 'christine.rioux-perreault.ciussse-chus@ssss.gouv.qc.ca'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1038/s41591-024-03173-6', 'label': 'Long COVID science, research and policy'}, {'url': 'https://doi.org/10.1038/s41579-022-00846-2', 'label': 'Long COVID: major findings, mechanisms and recommendations'}]}, 'descriptionModule': {'briefSummary': 'Background Long COVID (LC) is a chronic multisystemic condition which substantially impact the quality of life. Despite the staggering burden of LC, there is still no effective treatment.\n\nBecause fasting promotes anti-inflammatory and antioxidant responses, which are involved in the pathophysiology of LC, we hypothesized that it might improve daily functioning and health-related quality of life in patients with LC.\n\nThe aim of this single center, one arm, prospective pilot clinical trial will be to assess the feasibility and acceptability of prolonged fasting for LC. The main questions aims to answers are;\n\n1. Does in-home prolonged fasting (7 days) is feasible and acceptable for patients with LC\n2. Is there a clinical benefit associated with fasting is LC patients\n\nParticipants (adults 18 year and older) will be asked to\n\n1. Fast for 7 days\n2. Have in-person visit at baseline (day 0) and at day 9 for checkups and tests\n3. Answer difference questionnnaires about their perceived health during and after fasting'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-64 years\n* Diagnosis Long Covid based on WHO criteria (post-acute COVID-19 symptoms persisting ≥12 weeks) and validiated by an experienced cinician\n* Normal body Mass Index (18.5 to 39 kg/m2)\n* Able to communicate in and comprehend English and/or French language\n* Present written / signed declaration of consent\n* Ability to understand the patient information and willingness to sign the consent form\n* Willing to limit physical activity during prolonged fasting\n\nExclusion Criteria:\n\n* Current underweight condition (body mass index less than 18.5 kg/m2) or weight loss exceeding 3 kg within the last month or 5 kg within the last three months.\n* Current or history of eating disorder (e.g., anorexia, bulimia).\n* Psychiatric condition that limits understanding of the examination protocol (unable to consent)\n* Participation in another intervention study.\n* Fasting during the last six months\n* Pregnancy or breastfeeding status.\n* Diagnosis of chronic inflammatory bowel diseases, celiac disease or colorectal cancer according to the guidelines of the Canadian Society of Gastroenterology\n* Use of anti-psychotic drugs\n* Start of novel drug therapy for long COVID\n* Contraindication for additional blood draws (e.g. hemoglobin \\<100)\n* Taking opioid analgesics or undergoing treatment for opioid addiction\n* Opioid dependence or withdrawal syndrome\n* Type 1 or 2 Diabetes, or history of hypoglycemia\n* Active cancer\n* Baseline E+ (Na, K, Mg, phosphate) within normal range\n* Baseline ALT \\< 60\n* Baseline Hb \\> 100\n* Baseline INR within normal range\n* Baseline DFG \\< 50'}, 'identificationModule': {'nctId': 'NCT07418567', 'briefTitle': 'A Fasting Pilot Study for Long COVID', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'A Prospective Pilot Study to Evaluate the Feasibility of Prolonged Fasting for the Treatment of Long COVID Patients', 'orgStudyIdInfo': {'id': 'PF study'}, 'secondaryIdInfos': [{'id': 'Programme PAFI 2024-2025', 'type': 'OTHER', 'domain': 'Centre de recherche du CIUSSSE-CHUS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fasting arm', 'description': 'Participants will be allowed to continue their regular drug treatment', 'interventionNames': ['Other: prolonged fasting']}], 'interventions': [{'name': 'prolonged fasting', 'type': 'OTHER', 'description': 'Participants will be fasting for 7 days', 'armGroupLabels': ['Fasting arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de recherche du CIUSSSE-CHUS', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Except for the study protocol that we are willing to share, personal and confidential will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre de recherche du CHU de Sherbrooke', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}