Adverse Reaction to VaccineNCT04834869
COVID-19 Vaccines Safety Tracking (CoVaST)
An observational study of Adverse Reaction to Vaccine and COVID19 Vaccine, run by Masaryk University at 14 sites in 14 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Reaction to Vaccine, COVID19 Vaccine
- What is being tested?
- BNT162b2, mRNA-1273 and AZD1222
- Type of treatment
- Vaccines
- How many people
- 30,000 participants
- Where
- 14 sitesin 14 countries
- Study dates
- 1 Apr 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- HCW, OA and ST who received COVID-19 vaccine.
- Participating subjects should be at least 18-year-old and able to give their informed consent independently.
Who cannot join
- Non HCW, OA and ST who received the COVID-19.
Trial locations and contacts
14 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 14 countries
United States1 site, 1 recruiting
- Not yet recruiting
American College of Physicians
Philadelphia, Pennsylvania, 19106
Amir Qassem, MD, PhD, aqaseem@acponline.org
Canada1 site, 1 recruiting
- Not yet recruiting
McMaster University
Hamilton, Ontario
Holger Schünemann, MD, PhD, schuneh@mcmaster.ca
Croatia1 site, 1 recruiting
- Not yet recruiting
University of Split
Split
Tina Poklepović Peričić, DDS, PhD, tinapoklepovic@gmail.com
Marija Franka Žuljević, MD, marija.franka@gmail.com
Czechia1 site, 1 recruiting
- Recruiting
Masaryk University
Brno
Miloslav Klugar, PhD, klugar@med.muni.cz
Abanoub Riad, DDS, abanoub.riad@med.muni.cz
Estonia1 site, 1 recruiting
- Not yet recruiting
University of Tartu
Tartu
Mikk Jürisson, MD, PhD, mikk.jurisson@ut.ee
Ruth Klada, MD, PhD, ruth.kalda@ut.ee
Ethiopia1 site, 1 recruiting
- Recruiting
Jimma University
Jimma
Morankar Sudhakar, PhD, morankarsn@yahoo.com
Elias Yesuf, MD, PhD, elias.yesuf@gmail.com
Germany1 site, 1 recruiting
- Recruiting
Justus-Liebig University Giessen
Giessen
Sameh Attia, DDS, Sameh.Attia@dentist.med.uni-giessen.de
Ghana1 site, 1 recruiting
- Not yet recruiting
University of Ghana
Accra
Anthony Danso-Appiah, PhD, adanso-appiah@ug.edu.gh
Mexico1 site, 1 recruiting
- Not yet recruiting
Sinaloa's Pediatric Hospital
Culiacán
Giordano Pérez-Gaxiola, MD, MSc, giordano@cochrane.mx
Poland1 site, 1 recruiting
- Recruiting
Medical University of Silesia
Katowice
Arkadiusz Dziedzic, DDS, PhD, adziedzic@sum.edu.pl
Portugal1 site, 1 recruiting
- Not yet recruiting
Nursing School of Coimbra
Coimbra
João Apóstolo, PhD, apostolo@esenfc.pt
Russia1 site, 1 recruiting
- Recruiting
Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences
Irkutsk, 664033
Konstantin Apartsin, MD, PhD, director@isc.irk.ru
Serbia1 site, 1 recruiting
- Recruiting
University of Belgrade
Belgrade, 11221
Ivana Tadić, PhD, ivana.tadic@pharmacy.bg.ac.rs
Marina Odalović, PhD, marina.odalovic@pharmacy.bg.ac.rs
Slovenia1 site, 1 recruiting
- Not yet recruiting
University of Ljubljana
Ljubljana
Janja Marc, PharmD, janja.marc@ffa.uni-lj.si
About this study
Official title: COVID-19 Vaccines Safety Tracking: Global Consortium Study
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.
Read the detailed description
Introduction:
COVID-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.
Public 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.
Design
This 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.
Phase A:
A 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.
Phase B:
A 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.
- Conditions
- Adverse Reaction to Vaccine, COVID19 Vaccine
- Being tested
- BNT162b2, mRNA-1273, AZD1222, CoronaVac, Sinopharm
- Keywords
- COVID-19, Vaccines, Safety, Side Effects
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162b2Biological
Receiving either the first dose only or both doses of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 Vaccine)
mRNA-1273Biological
Receiving either the first dose only or both doses of mRNA-1273 vaccine (Moderna COVID-19 Vaccine)
AZD1222Biological
Receiving either the first dose only or both doses of AZD1222 vaccine (AstraZeneca-Oxford University COVID-19 Vaccine)
CoronaVacBiological
Receiving either the first dose only or both doses of CoronaVac (Sinovac COVID-19 Vaccine)
SinopharmBiological
Receiving either the first dose only or both doses of Sinopharm Vero Cell COVID-19 Vaccine
Gam-COVID-VacBiological
Receiving either the first dose only or both doses of Gam-COVID-Vac (Sputnik V)
JNJ-78436735Biological
Receiving JNJ-78436735 (Janssen COVID-19 Vaccine)
CVnCoVBiological
Receiving either the first dose only or both doses of CVnCoV (CureVac COVID-19 vaccine)
NVX-CoV2373Biological
Receiving either the first dose only or both doses of NVX-CoV2373 (Novavax COVID-19 vaccine)
BBV152Biological
Receiving either the first dose only or both doses of BBV152 (Covaxin COVID-19 vaccine)
| Study group | Role | What they receive |
|---|---|---|
| Pfizer-BioNTech COVID-19 Vaccine | Recently vaccinated individuals by Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) Receives: Biological: BNT162b2 | |
| Moderna COVID-19 Vaccine | Recently vaccinated individuals by Moderna COVID-19 Vaccine Receives: Biological: mRNA-1273 | |
| AstraZeneca-Oxford University COVID-19 Vaccine | Recently vaccinated individuals by AstraZeneca-Oxford University COVID-19 Vaccine (Vaxzevria) Receives: Biological: AZD1222 | |
| CoronaVac | Recently vaccinated individuals by CoronaVac (Sinovac COVID-19 Vaccine) Receives: Biological: CoronaVac | |
| Sinopharm | Recently vaccinated individuals by Vero Cells (Sinopharm COVID-19 Vaccine) Receives: Biological: Sinopharm | |
| Sputnik V | Recently vaccinated individuals by Sputnik V COVID-19 Vaccine Receives: Biological: Gam-COVID-Vac | |
| Janssen | Recently vaccinated individuals by Janssen COVID-19 Vaccine Receives: Biological: JNJ-78436735 | |
| CureVac | Recently vaccinated individuals by CureVac COVID-19 Vaccine Receives: Biological: CVnCoV | |
| Novavax | Recently vaccinated individuals by Novavax COVID-19 Vaccine Receives: Biological: NVX-CoV2373 | |
| Covaxin | Recently vaccinated individuals by Covaxin COVID-19 Vaccine Receives: Biological: BBV152 | |
| CanSino | Recently vaccinated individuals by CanSino COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Side Effects
Dichotomous outcome for the emergence of local side effects (e.g. injection site pain, injection site swelling, and injection site redness)
Measured: 0-30 days after the COVID-19 vaccine shot
Systemic Side Effects
Dichotomous outcome for the emergence of systemic side effects (e.g. fever, chills, headache, fatigue, nausea, diarrhea, etc)
Measured: 0-30 days after the COVID-19 vaccine shot
Secondary outcomes (1)
Unrecognized Side Effects
Dichotomous outcome for the emergence of oral and dermatologic side effects (e.g. oral paresthesia, oral ulcers, dysgeusia, skin rash, acne, urticaria, etc)
Measured: 0-30 days after the COVID-19 vaccine shot
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adverse Reaction to VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834869
- Sponsor's protocol ID
- CoVaST
- Status last verified
- Oct 2021
- First submitted
- 6 Apr 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33916020Riad 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.
PubMed 34360156
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Vaccines Safety Tracking: Global Consortium Study
- ClinicalTrials.gov ID
- NCT04834869
- Acronym / sponsor ID
- CoVaST
- Conditions
- Adverse Reaction to Vaccine, COVID19 Vaccine
- Keywords
- COVID-19, Vaccines, Safety, Side Effects
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction:
COVID-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.
Public 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.
Design
This 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.
Phase A:
A 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.
Phase B:
A 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Pfizer-BioNTech COVID-19 Vaccine | – | Biological: BNT162b2Recently vaccinated individuals by Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) |
| Moderna COVID-19 Vaccine | – | Biological: mRNA-1273Recently vaccinated individuals by Moderna COVID-19 Vaccine |
| AstraZeneca-Oxford University COVID-19 Vaccine | – | Biological: AZD1222Recently vaccinated individuals by AstraZeneca-Oxford University COVID-19 Vaccine (Vaxzevria) |
| CoronaVac | – | Biological: CoronaVacRecently vaccinated individuals by CoronaVac (Sinovac COVID-19 Vaccine) |
| Sinopharm | – | Biological: SinopharmRecently vaccinated individuals by Vero Cells (Sinopharm COVID-19 Vaccine) |
| Sputnik V | – | Biological: Gam-COVID-VacRecently vaccinated individuals by Sputnik V COVID-19 Vaccine |
| Janssen | – | Biological: JNJ-78436735Recently vaccinated individuals by Janssen COVID-19 Vaccine |
| CureVac | – | Biological: CVnCoVRecently vaccinated individuals by CureVac COVID-19 Vaccine |
| Novavax | – | Biological: NVX-CoV2373Recently vaccinated individuals by Novavax COVID-19 Vaccine |
| Covaxin | – | Biological: BBV152Recently vaccinated individuals by Covaxin COVID-19 Vaccine |
| CanSino | – | –Recently vaccinated individuals by CanSino COVID-19 Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- HCW, OA and ST who received COVID-19 vaccine.
- Participating subjects should be at least 18-year-old and able to give their informed consent independently.
Key exclusion criteria (1 listed)
- Non HCW, OA and ST who received the COVID-19.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNT162b2Receiving either the first dose only or both doses of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 Vaccine) | Biological | Pfizer-BioNTech COVID-19 Vaccine |
| mRNA-1273Receiving either the first dose only or both doses of mRNA-1273 vaccine (Moderna COVID-19 Vaccine) | Biological | Moderna COVID-19 Vaccine |
| AZD1222Receiving either the first dose only or both doses of AZD1222 vaccine (AstraZeneca-Oxford University COVID-19 Vaccine) | Biological | AstraZeneca-Oxford University COVID-19 Vaccine |
| CoronaVacReceiving either the first dose only or both doses of CoronaVac (Sinovac COVID-19 Vaccine) | Biological | CoronaVac |
| SinopharmReceiving either the first dose only or both doses of Sinopharm Vero Cell COVID-19 Vaccine | Biological | Sinopharm |
| Gam-COVID-VacReceiving either the first dose only or both doses of Gam-COVID-Vac (Sputnik V) | Biological | Sputnik V |
| JNJ-78436735Receiving JNJ-78436735 (Janssen COVID-19 Vaccine) | Biological | Janssen |
| CVnCoVReceiving either the first dose only or both doses of CVnCoV (CureVac COVID-19 vaccine) | Biological | CureVac |
| NVX-CoV2373Receiving either the first dose only or both doses of NVX-CoV2373 (Novavax COVID-19 vaccine) | Biological | Novavax |
| BBV152Receiving either the first dose only or both doses of BBV152 (Covaxin COVID-19 vaccine) | Biological | Covaxin |
Primary outcome
Local Side Effects
Time frame: 0-30 days after the COVID-19 vaccine shot
Dichotomous outcome for the emergence of local side effects (e.g. injection site pain, injection site swelling, and injection site redness)
Systemic Side Effects
Time frame: 0-30 days after the COVID-19 vaccine shot
Dichotomous outcome for the emergence of systemic side effects (e.g. fever, chills, headache, fatigue, nausea, diarrhea, etc)
1 secondary outcome
Unrecognized Side Effects
Time frame: 0-30 days after the COVID-19 vaccine shot
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Background: PubMed 33916020Riad 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.
- Derived from this study: PubMed 34360156Riad 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.
- Individual participant dataSharing planned: No
Related trials for Adverse Reaction to Vaccine
RecruitingObservational study
Genomics and COVID-19 Vaccine Adverse Events
Vaccine Adverse Reaction
Not yet recruitingPhase 1/2
Clinical Trial Phase I/IIa to Evaluate the Safety and Immunogenicity of StreptInCor
Rheumatic Heart Disease, Rheumatic Heart Disease in Children
Not yet recruitingPhase 3
Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
Vaccine Reaction, Vaccine Adverse Reaction
Not yet recruitingPhase 2
Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort
Vaccine Adverse Reaction, Post Acute Covid-19 Vaccination Syndrome
Not yet recruiting
A Multifaceted Intervention on Reducing Immunization Errors
Vaccines, Vaccines Adverse Reaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Reaction to Vaccine and COVID19 Vaccine, run by Masaryk University at 14 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada, Croatia, Czechia, Estonia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miloslav Klugar, PhD (+420549495676, klugar@med.muni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Side Effects (time frame: 0-30 days after the COVID-19 vaccine shot). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04834869, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.