Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT04584567
Status:
COMPLETED
Last Update Posted:
2021-11-19
First Post:
2020-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OD-doxy-PNV-COVID-19 Old Drug " DOXY " for Prevention of New Virus " COVID-19 "
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': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The participants who meeting study entry criteria will be randomized in a 1:1 blinded comparison of daily low dose DOXY versus oral placebo for 6 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-18', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'decreasing the number of cases infected with covid 19', 'timeFrame': 'WEEK 6', 'description': 'Determine if the use of doxyciciline low dose as preventive treatment decrease the number of cases infected with covid 19 in the active arm compared to the placebo arm. Participants for each randomized treatment arm as compared to placebo.'}], 'secondaryOutcomes': [{'measure': 'Measurement of the emergence of clincal symptoms of COVID 19', 'timeFrame': 'WEEK 6', 'description': 'Comparison of the emergence of clinical symptoms or COVID-19 diagnosis in participants presenting asymptomatically at study entry but identified as seropositive by serology at entry between the randomized treatment arms and comparator arm.'}, {'measure': 'the seroprevalence of SARS- CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving DOXY compared to those receiving placebo.', 'timeFrame': 'WEEK 6', 'description': 'Comparison of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized DOXY versus placebo.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Given the urgency of having guidelines for the management of COVID-19 in the current epidemic context and the lack of specific pharmacological treatment, Military Health recommends the launch of a multicenter, randomized, double-blind, interventional clinical trial.\n\nThe aim of this study is to evaluate the efficacy of a combination of two treatments, low-dose doxcycline (100 mg/day) and Zinc (15 mg/day) (dietary supplement) in the primary prevention of COVID-19 infection in health care professionals in Tunisia compared to two control groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No self-medication with study drugs or antivirals\n* Negative COVID19 diagnosis confirmed by PCR and negative Elisa antibody assay\n* No signs of COVID19\n* Having given consent for the study\n\nExclusion Criteria:\n\nParticipation in other clinical trials aimed at primary prevention of VIDOC infection19\n\n* Liver failure\n* Known allergy to the study product\n* Pregnancy or breastfeeding\n* Vitamin A and E treatment in progress'}, 'identificationModule': {'nctId': 'NCT04584567', 'briefTitle': 'OD-doxy-PNV-COVID-19 Old Drug " DOXY " for Prevention of New Virus " COVID-19 "', 'organization': {'class': 'NETWORK', 'fullName': 'General Administration of Military Health, Tunisia'}, 'officialTitle': 'Covid-19 Infection Prophylaxis With Low Dose of Doxycycline and Zinc in Health Care Workers', 'orgStudyIdInfo': {'id': 'UR17DN05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DOXY ZINC', 'description': 'Doxycycline daily dosing (100mg) Zinc daily dosing (15mg)', 'interventionNames': ['Drug: Doxycyclin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'DOXY PLACEBO', 'description': 'Doxycycline daily dosing (100mg) placebo of Zinc', 'interventionNames': ['Drug: Doxycyclin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO', 'description': 'placebo of Doxycycline daily dosing placebo of Zinc', 'interventionNames': ['Drug: Doxycyclin']}], 'interventions': [{'name': 'Doxycyclin', 'type': 'DRUG', 'description': 'daily (100mg)', 'armGroupLabels': ['DOXY PLACEBO', 'DOXY ZINC', 'PLACEBO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1008', 'city': 'Tunis', 'state': 'Montfleury', 'country': 'Tunisia', 'facility': 'Military Hospital of Tunis', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Batikh R Riadh, physican', 'role': 'STUDY_CHAIR', 'affiliation': 'Military hospital'}, {'name': 'Stambouli N nejla, phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Military hospital'}, {'name': 'Gharsallah H Hedi, physican', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Military hospital'}, {'name': 'Ferjani M Mustapha, physican', 'role': 'STUDY_CHAIR', 'affiliation': 'Direction de la Santé militaire'}, {'name': 'Ben Moussa M mohamed, physican', 'role': 'STUDY_CHAIR', 'affiliation': 'Military hospital'}, {'name': 'Youssfi MA Mohamed Al, physican', 'role': 'STUDY_CHAIR', 'affiliation': 'Military hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hedi Gharsallah', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Dacima Consulting', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hedi Gharsallah', 'investigatorAffiliation': 'General Administration of Military Health, Tunisia'}}}}