Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-27 @ 12:00 PM
Study NCT ID:
NCT04773756
Status:
COMPLETED
Last Update Posted:
2021-02-26
First Post:
2021-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'C549273', 'term': 'daclatasvir'}], 'ancestors': [{'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2021-02-22', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluate the combined effect of Sofosbuvir and Daclatasvir in treatment of patients with mild-moderate Covid-19.', 'timeFrame': 'it is estimated to be 2 weeks', 'description': 'The study assesses the incidence of resolution of symptoms in COVID patients after taking Sofosbuvir and Daclatasvir for 14 days by doing PCR and the result to be negative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sofosbuvir', 'Daclatasvir'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Sofosbuvir has been recently recommended as a possible antiviral for COVID-19, based on structural studies and multiple alignment analysis. By comparing the positive-stranded RNA genomes of HCV and SARS-CoV-2, it has been postulated that sofosbuvir might be an optimal nucleotide analogue to repurpose for COVID-19 treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild- moderate COVID-19 confirmed by PCR\n\nExclusion Criteria:\n\n1. Patients on renal dialysis\n2. Severe COVID-19 cases\n3. Patients on amiodarone therapy (given the reported FDA warning of an interaction between amiodarone and sofosbuvir that might lead to severe bradycardia).\n4. Children \\< 12 years\n5. Pregnant and breast feeding women\n6. Exacerbation of hepatitis B'}, 'identificationModule': {'nctId': 'NCT04773756', 'briefTitle': 'Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt (Single Center Study)', 'orgStudyIdInfo': {'id': '0305032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sofosbuvir / Daclatsvir', 'description': 'A drug used in the treatment of HCV infection, given in the same dose 400mg and 60 mg respectively once daily for 14 days', 'interventionNames': ['Drug: Sofosbuvir 400 MG/ Daclatasvir 60mg']}], 'interventions': [{'name': 'Sofosbuvir 400 MG/ Daclatasvir 60mg', 'type': 'DRUG', 'description': 'Giving these two drugs for treatment of COVID patients', 'armGroupLabels': ['Sofosbuvir / Daclatsvir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21521', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Amr Aly Abd elmoety', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Amr Abd elmoety, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University, Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Internal Medicine Department', 'investigatorFullName': 'Amr Aly Abd Elmoety', 'investigatorAffiliation': 'Alexandria University'}}}}