Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-27 @ 10:36 PM
Study NCT ID:
NCT05271461
Status:
UNKNOWN
Last Update Posted:
2022-03-09
First Post:
2022-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Hyper Coagulability Care by LLLT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'circulatory exercise only, circulatory exercises and LLLT.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups of 30 patients, 1st circulatory exercise, 2nd LLLT and circulatory exercises.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-06-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2022-02-14', 'studyFirstSubmitQcDate': '2022-03-08', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circulatory group laboratory investigation.', 'timeFrame': 'Monthly (an average of two months)', 'description': 'D-dimer≥.5mg/dL, fibrinogen\\>2.5mg/dL\n\nTo examine COVID-19 recovery.'}, {'measure': 'Circulatory group: CBC analysis.', 'timeFrame': 'Daily (an average of two months)', 'description': 'Lymphocyte count\\<1.500mm3, Platelet count\\<150.000mm3, to examine COVID-19 recovery.'}, {'measure': 'Circulatory group (PT, PTT).', 'timeFrame': 'Bi weekly (an average of two months)', 'description': 'Prothrombin time\\>3 sec, activated partial thromboplastin time\\>5 sec to examine COVID-19 recovery.'}, {'measure': 'Circulatory group physical examination.', 'timeFrame': 'Every two days (an average of two months)', 'description': 'by visual analog scale is horizontal line 100mm length the ends defined as extreme limit of the parameter measured (symptom, pain, health) orientated from the left (the worst) the right (the best) 3 times per week to detect DVT.'}, {'measure': 'Circulatory group. BMI.', 'timeFrame': 'Day one', 'description': 'weight kg on height m2 to detect liability for DVT.'}, {'measure': 'Especially Lab investigation.', 'timeFrame': 'Baseline', 'description': 'C-reactive protein ≥10mg/l for diagnosis of the recovery.'}], 'secondaryOutcomes': [{'measure': 'LLLT group laboratory investigation.', 'timeFrame': 'Monthly (an average of two months)', 'description': 'D-dimer≥,5mg/dl, fibrinogen\\>2.5mg/dl, c-reactive protein≥10mg/dl to examine COVID-19 recovery.\n\nFibrinogen'}, {'measure': 'LLLT group CBC analysis.', 'timeFrame': 'Daily (an average of two months)', 'description': 'lymphocyte count\\<1,500mm3, platelet count\\<150,000mm3, for examine COVID-19 recovery.'}, {'measure': 'LLLT group. {PTT, PT}.', 'timeFrame': 'Bi weekly (an average of two months)', 'description': 'Prothrombin time\\>3 sec, activated partial thromboplastin time\\>5sec to examine COVID-19 recovery.'}, {'measure': 'LLLT group physical examination.', 'timeFrame': 'Every two days (an average of two months)', 'description': 'by visual analog scale is a straight horizontal line of fixed length 100mm the end is extreme limit of the parameter measured (symptom, pain, health) orientated from the left (the worst) to the right (the best) 3times per week to detect DVT.'}, {'measure': 'LLLT group. BMI.', 'timeFrame': 'Day one', 'description': 'Weight kg/height m2 to detect liability for DVT.'}, {'measure': 'Specifically Lab investigation.', 'timeFrame': 'Baseline', 'description': 'C\\_reactive protein≥10mg/l.help diagnosis of the recovery.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Pneumonia']}, 'referencesModule': {'references': [{'pmid': '10805940', 'type': 'BACKGROUND', 'citation': 'Agaiby AD, Ghali LR, Wilson R, Dyson M. Laser modulation of angiogenic factor production by T-lymphocytes. Lasers Surg Med. 2000;26(4):357-63. doi: 10.1002/(sici)1096-9101(2000)26:43.0.co;2-o.'}, {'pmid': '32232218', 'type': 'BACKGROUND', 'citation': 'Emami A, Javanmardi F, Pirbonyeh N, Akbari A. Prevalence of Underlying Diseases in Hospitalized Patients with COVID-19: a Systematic Review and Meta-Analysis. Arch Acad Emerg Med. 2020 Mar 24;8(1):e35. eCollection 2020.'}, {'type': 'BACKGROUND', 'citation': 'ConnorsJ.M.,LevyJ.H(2020).Thromboinflammation and the hyper coagulability of COVID-19.JThromb Haemost https://doi.org/10.1111/jth.14849.'}]}, 'descriptionModule': {'briefSummary': 'COVID-19 clotting Safety', 'detailedDescription': 'Covid-19 patients have liability for hyper coagulability, low level laser Therapy improve circulation and decrease liability for hyper coagulability accompanied with circulatory exercises .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI from 18.5 to 29.9 kg/m2\n* Moderate elevated percentage of coagulative factors for COVID-19 Diagnosis:\n* Nasopharyngeal swab\n* Sepsis induced coagulopathy score\\>4\n* D\\_dimer≥0,5mg/L\n* Fibrinogen\\>2,5gm/L\n* C\\_reactive protein≥10mg/L\n* Lymphocyte count\\<1,500mm3\n* Platelet count\\<150,000mm3\n* Prothrombin time increase\\>3sec\n* Activated partial thromboplastin time increase\\>5sec\n* Same level of physical activity\n* Patients can swallow tablets\n* CT scan screening method for COVID-19 Diagnosis\n* Physical examination\n\nExclusion Criteria:\n\n* hyper tension\n* Cognitive impairment e.g (delirium)\n* Diabetes mellitus both types dependant or non\n* Disabled musculoskeletal Disorders e.g hemi paresis\n* Coronary artery diseases and heart failure\n* DVT\n* Stroke, bone disease, renal failure, pulmonary embolism\n* Vitamins deficiency\n* 6 months post large surgeries\n* Alcohol intake and smokers\n* Thyroid diseases'}, 'identificationModule': {'nctId': 'NCT05271461', 'acronym': 'LLLT', 'briefTitle': 'COVID-19 Hyper Coagulability Care by LLLT', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Low Level Laser Therapy on Hyper Coagulability in Patients With Covid-19', 'orgStudyIdInfo': {'id': 'COVID-19 LLLT.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Circulatory exercises group .', 'description': 'Circulatory exercises.', 'interventionNames': ['Other: Circulatory exercises']}, {'type': 'EXPERIMENTAL', 'label': 'LLLT group .', 'description': 'Low level laser Therapy + circulatory exercises.', 'interventionNames': ['Radiation: Low level laser Therapy', 'Other: Circulatory exercises']}], 'interventions': [{'name': 'Low level laser Therapy', 'type': 'RADIATION', 'description': 'Pin pointed application of low level laser on 15 acupuncture points each point 1 min time of application 15 min.', 'armGroupLabels': ['LLLT group .']}, {'name': 'Circulatory exercises', 'type': 'OTHER', 'description': 'Active assisted or against mild resistance. Supine with leg up position 18degrees measured by the bed water balance in side rails.\n\nIf patient is not comfortable according to the modified Borg scale or contra indicated for the position then assume the supine position.\n\nThe subject will have A 3 min rest period to acclimatize themselves to each position.\n\nThe ankle pumping exercises consisted of simple repetitions of dorsiflexion 1 sec and planter- flexion for 1 sec with three different exercise intervals:\n\n* repeated dorsiflexion and planter-flexion with no rest (no rest exercise).\n* repeated dorsiflexion and planter-flexion with a 2 sec rest period (2 sec rest exercise).\n* repeated dorsiflexion and planter-flexion with 4sec rest period (4sec rest exercise).\n\nSubjects will have practiced ankle pumps before the exercise to get familiar and be educated about the procedure.', 'armGroupLabels': ['Circulatory exercises group .', 'LLLT group .']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12611', 'city': 'Dokki', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Enas Dr Ahmed, Bsc', 'role': 'CONTACT', 'email': 'enaswagdydaib@gmail.com', 'phone': '01028406164', 'phoneExt': 'Therapist'}, {'name': 'Bsc', 'role': 'CONTACT', 'email': 'enaswagdydaib@gmail.com', 'phone': '01028406164', 'phoneExt': 'Therapist'}], 'facility': 'Physical therapy faculty', 'geoPoint': {'lat': 30.03823, 'lon': 31.2113}}], 'centralContacts': [{'name': 'Enas Dr Ahmed, BSC', 'role': 'CONTACT', 'email': 'enaswagdydaib@gmail.com', 'phone': '01028406164', 'phoneExt': 'Therapist'}], 'overallOfficials': [{'name': 'Enas Dr Ahmed, BSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physical therapy faculty CairoU.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Enas Wagdy Elsaid Ahmed', 'investigatorAffiliation': 'Cairo University'}}}}