Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-03-17 @ 3:16 AM
Study NCT ID:
NCT04834869
Status:
RECRUITING
Last Update Posted:
2022-04-06
First Post:
2021-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Vaccines Safety Tracking (CoVaST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Iran', 'Romania', 'Spain']}, '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': 'D000090982', 'term': 'BNT162 Vaccine'}, {'id': 'D000090983', 'term': '2019-nCoV Vaccine mRNA-1273'}, {'id': 'D000090985', 'term': 'ChAdOx1 nCoV-19'}, {'id': 'C000722216', 'term': 'sinovac COVID-19 vaccine'}, {'id': 'C000718911', 'term': 'Gam-COVID-Vac vaccine'}, {'id': 'D000090984', 'term': 'Ad26COVS1'}, {'id': 'C000722934', 'term': 'CVnCoV COVID-19 vaccine'}, {'id': 'C000711928', 'term': 'NVX-CoV2373 adjuvated lipid nanoparticle'}, {'id': 'C000722386', 'term': 'BBV152 COVID-19 vaccine'}], 'ancestors': [{'id': 'D000087503', 'term': 'mRNA Vaccines'}, {'id': 'D000087504', 'term': 'Nucleic Acid-Based Vaccines'}, {'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D019444', 'term': 'Vaccines, DNA'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2021-04-06', 'studyFirstSubmitQcDate': '2021-04-06', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Side Effects', 'timeFrame': '0-30 days after the COVID-19 vaccine shot', 'description': 'Dichotomous outcome for the emergence of local side effects (e.g. injection site pain, injection site swelling, and injection site redness)'}, {'measure': 'Systemic Side Effects', 'timeFrame': '0-30 days after the COVID-19 vaccine shot', 'description': 'Dichotomous outcome for the emergence of systemic side effects (e.g. fever, chills, headache, fatigue, nausea, diarrhea, etc)'}], 'secondaryOutcomes': [{'measure': 'Unrecognized Side Effects', 'timeFrame': '0-30 days after the COVID-19 vaccine shot', 'description': 'Dichotomous outcome for the emergence of oral and dermatologic side effects (e.g. oral paresthesia, oral ulcers, dysgeusia, skin rash, acne, urticaria, etc)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Vaccines', 'Safety', 'Side Effects'], 'conditions': ['Adverse Reaction to Vaccine', 'COVID19 Vaccine']}, 'referencesModule': {'references': [{'pmid': '33916020', 'type': 'BACKGROUND', 'citation': 'Riad A, Pokorna A, Attia S, Klugarova J, Koscik M, Klugar M. Prevalence of COVID-19 Vaccine Side Effects among Healthcare Workers in the Czech Republic. J Clin Med. 2021 Apr 1;10(7):1428. doi: 10.3390/jcm10071428.'}, {'pmid': '34360156', 'type': 'DERIVED', 'citation': "Riad A, Schunemann H, Attia S, Pericic TP, Zuljevic MF, Jurisson M, Kalda R, Lang K, Morankar S, Yesuf EA, Mekhemar M, Danso-Appiah A, Sofi-Mahmudi A, Perez-Gaxiola G, Dziedzic A, Apostolo J, Cardoso D, Marc J, Moreno-Casbas M, Wiysonge CS, Qaseem A, Gryschek A, Tadic I, Hussain S, Khan MA, Klugarova J, Pokorna A, Koscik M, Klugar M. COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines' Side Effects. Int J Environ Res Public Health. 2021 Jul 25;18(15):7859. doi: 10.3390/ijerph18157859."}]}, 'descriptionModule': {'briefSummary': 'This project aims to monitor the side effects of COVID-19 vaccines worldwide actively. The primary objectives of the project include a) to estimate the prevalence of each local and systemic side effect of each COVID-19 vaccine among healthcare workers (HCW), old adults over +65 (OA), and schoolteachers (ST); b) to evaluate the potential demographic and medical risk factors for side effects frequency and intensity; c) to evaluate the long-term consequences of COVID-19 vaccines. The secondary objectives include a) to evaluate the relative safety of COVID-19 vaccines compared to each other; b) to evaluate the impact of palliative drugs used by the recently vaccinated individuals on their short-term side effects resolution.', 'detailedDescription': 'Introduction:\n\nCOVID-19 vaccines are the foremost asset to overcome the ongoing pandemic; therefore, mass vaccination has become a high priority for the world\'s governments. While vaccination strategies need to be accelerated to minimise daily fatalities and relieve the pandemic\'s economic burdens, vaccine hesitancy (VH) remains a serious challenge for these efforts. VH refers to "delay in acceptance or refusal of vaccines despite availability of vaccine services",; and it is an emerging public health challenge nourished by misinformation related to vaccines effectiveness and safety. Aversion to vaccines\' potential side effects is the most frequent cause of VH among population groups. Therefore, a recent systematic review revealed that raising public awareness of vaccines\' effectiveness and side effects is vital for improving vaccine uptake.\n\nPublic health systems globally experience a novel and unique challenge due to the variety of vaccines manufacturers and the high levels of public awareness about those manufacturers and their marketing strategies. This unprecedented situation is predicted to create what we can refer to as "vaccine selectivity, " increasing the pressure on our weakened health systems and economies and increasing vaccine hesitancy levels. Independent (non-sponsored) studies with rigorous methods can perfectly lead the pharmacovigilance efforts of COVID-19 vaccines globally. Given their independent nature and transparent design, these studies can play a key role in suppressing vaccine hesitancy levels by enhancing public confidence in vaccines.\n\nDesign\n\nThis project comprises two phases; a) a cross-sectional survey for the short-term side effects of COVID-19 vaccines; b) a prospective cohort study for the long-term safety of COVID-19 vaccines.\n\nPhase A:\n\nA validated self-administered questionnaire will be developed and delivered online to the target population groups (HCW, OA \\& ST). The questionnaire will be inquiring about the short-term side effects that emerged within 30 days following the vaccine shot (either the first or the second dose). The side effects will be classified as local or systemic, and their onset, duration, and intensity will be self-assessed and self-reported by the respondents. This phase is proposed to take place until December 31st, 2021.\n\nPhase B:\n\nA validated self-administered questionnaire will be developed and delivered online to the volunteers who participated in Phase A and expressed their interest to report their long-term side effects. In this phase, the vaccine effectiveness and side effects will be evaluated after booster doses. Phase B will take place for five consecutive years starting from 2022.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In Phase A, a pragmatic approach will track each target group according to the governmental plan; in most countries, it went from HCW to OA to ST. The sample of Phase B will be pre-identified based on the outcome of Phase A. If ≥ 25% of HCW, 10% of OA and 10% of ST of Phase A showed their interest to join Phase B, no additional recruitment will be required. If \\< 25% of HCW, 10% of OA and 10% of ST of Phase A showed their interest in Phase B, additional recruitment will be carried out targeting healthcare workers who will receive booster doses. In case of the emergence of special side effects after booster doses, additional recruitment of healthcare workers will be required.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HCW, OA and ST who received COVID-19 vaccine.\n* Participating subjects should be at least 18-year-old and able to give their informed consent independently.\n\nExclusion Criteria:\n\n* Non HCW, OA and ST who received the COVID-19.'}, 'identificationModule': {'nctId': 'NCT04834869', 'briefTitle': 'COVID-19 Vaccines Safety Tracking (CoVaST)', 'organization': {'class': 'OTHER', 'fullName': 'Masaryk University'}, 'officialTitle': 'COVID-19 Vaccines Safety Tracking: Global Consortium Study', 'orgStudyIdInfo': {'id': 'CoVaST'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pfizer-BioNTech COVID-19 Vaccine', 'description': 'Recently vaccinated individuals by Pfizer-BioNTech COVID-19 Vaccine (Comirnaty)', 'interventionNames': ['Biological: BNT162b2']}, {'label': 'Moderna COVID-19 Vaccine', 'description': 'Recently vaccinated individuals by Moderna COVID-19 Vaccine', 'interventionNames': ['Biological: mRNA-1273']}, {'label': 'AstraZeneca-Oxford University COVID-19 Vaccine', 'description': 'Recently vaccinated individuals by AstraZeneca-Oxford University COVID-19 Vaccine (Vaxzevria)', 'interventionNames': ['Biological: AZD1222']}, {'label': 'CoronaVac', 'description': 'Recently vaccinated individuals by CoronaVac (Sinovac COVID-19 Vaccine)', 'interventionNames': ['Biological: CoronaVac']}, {'label': 'Sinopharm', 'description': 'Recently vaccinated individuals by Vero Cells (Sinopharm COVID-19 Vaccine)', 'interventionNames': ['Biological: Sinopharm']}, {'label': 'Sputnik V', 'description': 'Recently vaccinated individuals by Sputnik V COVID-19 Vaccine', 'interventionNames': ['Biological: Gam-COVID-Vac']}, {'label': 'Janssen', 'description': 'Recently vaccinated individuals by Janssen COVID-19 Vaccine', 'interventionNames': ['Biological: JNJ-78436735']}, {'label': 'CureVac', 'description': 'Recently vaccinated individuals by CureVac COVID-19 Vaccine', 'interventionNames': ['Biological: CVnCoV']}, {'label': 'Novavax', 'description': 'Recently vaccinated individuals by Novavax COVID-19 Vaccine', 'interventionNames': ['Biological: NVX-CoV2373']}, {'label': 'Covaxin', 'description': 'Recently vaccinated individuals by Covaxin COVID-19 Vaccine', 'interventionNames': ['Biological: BBV152']}, {'label': 'CanSino', 'description': 'Recently vaccinated individuals by CanSino COVID-19 Vaccine'}], 'interventions': [{'name': 'BNT162b2', 'type': 'BIOLOGICAL', 'description': 'Receiving either the first dose only or both doses of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 Vaccine)', 'armGroupLabels': ['Pfizer-BioNTech COVID-19 Vaccine']}, {'name': 'mRNA-1273', 'type': 'BIOLOGICAL', 'description': 'Receiving either the first dose only or both doses of mRNA-1273 vaccine (Moderna COVID-19 Vaccine)', 'armGroupLabels': ['Moderna COVID-19 Vaccine']}, {'name': 'AZD1222', 'type': 'BIOLOGICAL', 'description': 'Receiving either the first dose only or both doses of AZD1222 vaccine (AstraZeneca-Oxford University COVID-19 Vaccine)', 'armGroupLabels': ['AstraZeneca-Oxford University COVID-19 Vaccine']}, {'name': 'CoronaVac', 'type': 'BIOLOGICAL', 'description': 'Receiving either the first dose only or both doses of CoronaVac (Sinovac COVID-19 Vaccine)', 'armGroupLabels': ['CoronaVac']}, {'name': 'Sinopharm', 'type': 'BIOLOGICAL', 'description': 'Receiving either the first dose only or both doses of Sinopharm Vero Cell COVID-19 Vaccine', 'armGroupLabels': ['Sinopharm']}, {'name': 'Gam-COVID-Vac', 'type': 'BIOLOGICAL', 'description': 'Receiving either the first dose only or both doses of Gam-COVID-Vac (Sputnik V)', 'armGroupLabels': ['Sputnik V']}, {'name': 'JNJ-78436735', 'type': 'BIOLOGICAL', 'description': 'Receiving JNJ-78436735 (Janssen COVID-19 Vaccine)', 'armGroupLabels': ['Janssen']}, {'name': 'CVnCoV', 'type': 'BIOLOGICAL', 'description': 'Receiving either the first dose only or both doses of CVnCoV (CureVac COVID-19 vaccine)', 'armGroupLabels': ['CureVac']}, {'name': 'NVX-CoV2373', 'type': 'BIOLOGICAL', 'description': 'Receiving either the first dose only or both doses of NVX-CoV2373 (Novavax COVID-19 vaccine)', 'armGroupLabels': ['Novavax']}, {'name': 'BBV152', 'type': 'BIOLOGICAL', 'description': 'Receiving either the first dose only or both doses of BBV152 (Covaxin COVID-19 vaccine)', 'armGroupLabels': ['Covaxin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19106', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amir Qassem, MD, PhD', 'role': 'CONTACT', 'email': 'aqaseem@acponline.org'}], 'facility': 'American College of Physicians', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Hamilton', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Holger Schünemann, MD, PhD', 'role': 'CONTACT', 'email': 'schuneh@mcmaster.ca'}], 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Split', 'status': 'NOT_YET_RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Tina Poklepović Peričić, DDS, PhD', 'role': 'CONTACT', 'email': 'tinapoklepovic@gmail.com'}, {'name': 'Marija Franka Žuljević, MD', 'role': 'CONTACT', 'email': 'marija.franka@gmail.com'}], 'facility': 'University of Split', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}, {'city': 'Brno', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Miloslav Klugar, PhD', 'role': 'CONTACT', 'email': 'klugar@med.muni.cz'}, {'name': 'Abanoub Riad, DDS', 'role': 'CONTACT', 'email': 'abanoub.riad@med.muni.cz'}], 'facility': 'Masaryk University', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Tartu', 'status': 'NOT_YET_RECRUITING', 'country': 'Estonia', 'contacts': [{'name': 'Mikk Jürisson, MD, PhD', 'role': 'CONTACT', 'email': 'mikk.jurisson@ut.ee'}, {'name': 'Ruth Klada, MD, PhD', 'role': 'CONTACT', 'email': 'ruth.kalda@ut.ee'}, {'name': 'Katrin Lang, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Tartu', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'city': 'Jimma', 'status': 'RECRUITING', 'country': 'Ethiopia', 'contacts': [{'name': 'Morankar Sudhakar, PhD', 'role': 'CONTACT', 'email': 'morankarsn@yahoo.com'}, {'name': 'Elias Yesuf, MD, PhD', 'role': 'CONTACT', 'email': 'elias.yesuf@gmail.com'}], 'facility': 'Jimma University', 'geoPoint': {'lat': 7.67344, 'lon': 36.83441}}, {'city': 'Giessen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sameh Attia, DDS', 'role': 'CONTACT', 'email': 'Sameh.Attia@dentist.med.uni-giessen.de'}], 'facility': 'Justus-Liebig University Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'city': 'Accra', 'status': 'NOT_YET_RECRUITING', 'country': 'Ghana', 'contacts': [{'name': 'Anthony Danso-Appiah, PhD', 'role': 'CONTACT', 'email': 'adanso-appiah@ug.edu.gh'}], 'facility': 'University of Ghana', 'geoPoint': {'lat': 5.55602, 'lon': -0.1969}}, {'city': 'Culiacán', 'status': 'NOT_YET_RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Giordano Pérez-Gaxiola, MD, MSc', 'role': 'CONTACT', 'email': 'giordano@cochrane.mx'}], 'facility': "Sinaloa's Pediatric Hospital", 'geoPoint': {'lat': 24.80209, 'lon': -107.39421}}, {'city': 'Katowice', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Arkadiusz Dziedzic, DDS, PhD', 'role': 'CONTACT', 'email': 'adziedzic@sum.edu.pl'}], 'facility': 'Medical University of Silesia', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Coimbra', 'status': 'NOT_YET_RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'João Apóstolo, PhD', 'role': 'CONTACT', 'email': 'apostolo@esenfc.pt'}], 'facility': 'Nursing School of Coimbra', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '664033', 'city': 'Irkutsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Konstantin Apartsin, MD, PhD', 'role': 'CONTACT', 'email': 'director@isc.irk.ru'}], 'facility': 'Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'zip': '11221', 'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'contacts': [{'name': 'Ivana Tadić, PhD', 'role': 'CONTACT', 'email': 'ivana.tadic@pharmacy.bg.ac.rs'}, {'name': 'Marina Odalović, PhD', 'role': 'CONTACT', 'email': 'marina.odalovic@pharmacy.bg.ac.rs'}], 'facility': 'University of Belgrade', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Ljubljana', 'status': 'NOT_YET_RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Janja Marc, PharmD', 'role': 'CONTACT', 'email': 'janja.marc@ffa.uni-lj.si'}], 'facility': 'University of Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Miloslav Klugar, PhD', 'role': 'CONTACT', 'email': 'klugar@med.muni.cz', 'phone': '+420549495676'}, {'name': 'Abanoub Riad, DDS', 'role': 'CONTACT', 'email': 'abanoub.riad@med.muni.cz', 'phone': '+420549496572'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masaryk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}