Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-31 @ 2:21 PM
Study NCT ID:
NCT04473261
Status:
UNKNOWN
Last Update Posted:
2021-07-07
First Post:
2020-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Iodine Complex Against COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002214', 'term': 'Capsules'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'empty capsule will be given as a placebo'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled, multi-armed, close-label, interventional study designed'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-04', 'studyFirstSubmitDate': '2020-07-14', 'studyFirstSubmitQcDate': '2020-07-14', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'qRT-PCR', 'timeFrame': '14 days', 'description': 'Time taken for viral load clearance'}, {'measure': 'HRCT chest', 'timeFrame': '14 days', 'description': 'Time taken for radiological improvement'}], 'secondaryOutcomes': [{'measure': 'Severity of Symptoms', 'timeFrame': '14 days', 'description': 'Time taken for symptomatic response in patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-Cov-2', 'COVID-19', 'Coronavirus', 'Iodine Complex'], 'conditions': ['Covid19', 'SARS-CoV-2', 'Corona Virus Infection']}, 'referencesModule': {'references': [{'pmid': '33568226', 'type': 'DERIVED', 'citation': 'Ashraf S, Ashraf S, Ashraf M, Imran MA, Kalsoom L, Siddiqui UN, Farooq I, Ghufran M, Khokhar RA, Akram MK, Shahid I, Sohaib Ur Rehman M, Akmal R, Tahir A, Zahid A, Ashraf S, Rafique S, Matti N, Nadeem MF, Humayun A, Malik A, Saboor QA, Ahmad A, Ashraf M, Izhar M. A quadruple blinded placebo controlled randomised trial to evaluate the effectiveness of an Iodine complex for patients with mild to moderate COVID-19 in Pakistan (I-COVID-PK): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Feb 10;22(1):127. doi: 10.1186/s13063-021-05081-3.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to measure the effect of Iodine complex in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.', 'detailedDescription': 'The proposed study is a placebo-controlled, add-on, randomized trial using parallel group designs. This is a close-label and adaptive, multi-centered design with 1:1:1:1 allocation ratio and superiority framework.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive PCR with mild to moderate disease\n\nExclusion Criteria:\n\n* Allergic to iodine\n* Any co-morbidity other than hypertension and dietetics'}, 'identificationModule': {'nctId': 'NCT04473261', 'acronym': 'I-COVID-PK', 'briefTitle': 'Efficacy of Iodine Complex Against COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sheikh Zayed Federal Postgraduate Medical Institute'}, 'officialTitle': 'Efficacy of Iodine Complex in Mild to Moderate COVID-19 Patients', 'orgStudyIdInfo': {'id': 'SZMC/IRB/Internal/216/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iodine Complex (Capsule form)', 'description': 'Iodine Complex) capsule (200mg) will be given three times a day', 'interventionNames': ['Drug: Iodine Complex']}, {'type': 'EXPERIMENTAL', 'label': 'Iodine Complex (Syrup form)', 'description': 'Iodine Complex syrup form (40ml) will be given three times a day', 'interventionNames': ['Drug: Iodine Complex']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard Care Alone', 'description': 'Placebo as empty capsule. Treatment will be given for all 4 arms will be receiving standard care as per version 3.0 of clinical management guidelines for COVID-19 established by the Ministry of National Health Services of Pakistan COVID-19 guidelines of the study setting.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Iodine Complex (Nasal Spray)', 'description': 'Iodine complex throat spray of 2 puffs three times a day.', 'interventionNames': ['Drug: Idoine Complex']}], 'interventions': [{'name': 'Iodine Complex', 'type': 'DRUG', 'description': 'Iodine Complex capsule (200mg) will be given three times a day', 'armGroupLabels': ['Iodine Complex (Capsule form)']}, {'name': 'Iodine Complex', 'type': 'DRUG', 'description': 'Iodine Complex syrup form (40ml) will be given three times a day', 'armGroupLabels': ['Iodine Complex (Syrup form)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['capsule'], 'description': 'Empty capsule will be given as placebo', 'armGroupLabels': ['Standard Care Alone']}, {'name': 'Idoine Complex', 'type': 'DRUG', 'description': 'Iodine Complex spray form 2 puffs will be given three times a day', 'armGroupLabels': ['Iodine Complex (Nasal Spray)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54600', 'city': 'Lahore', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Sohaib Ashraf, MBBS', 'role': 'CONTACT', 'email': 'sohaib@skzmdc.edu.pk', 'phone': '+923334474523'}, {'name': 'Muhammad Ahmad Imran, MBBS', 'role': 'CONTACT', 'email': 'ahmad.ammy93@gmail.com', 'phone': '+923338110708'}, {'name': 'Muhammad Ahmad Imran, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Uzma Nasim, FCPS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shaikh Zayed Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Sohaib Ashraf, MBBS', 'role': 'CONTACT', 'email': 'sohaib-ashraf@outlook.com', 'phone': '+923334474523'}, {'name': 'Shoaib Ashraf, PhD', 'role': 'CONTACT', 'email': 'sashraf@mgh.harvard.edu', 'phone': '+16177949579'}], 'overallOfficials': [{'name': 'Muhammad Ashraf, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Veterinary & Animal Sciences, Pakistan'}, {'name': 'Shoaib Ashraf, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Harvard University, Massachusetts General Hospital, Boston, USA'}, {'name': 'Moneeb Ashraf, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Hospital, Pakistan'}, {'name': 'Sohaib Ashraf, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaikh Zayed Medical Complex, Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohaib Ashraf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Post-Graduate Resident Cardiology', 'investigatorFullName': 'Sohaib Ashraf', 'investigatorAffiliation': 'Sheikh Zayed Federal Postgraduate Medical Institute'}}}}