Coronavirus Disease 2019 (COVID-19) Clinical Trial
Official title:
A Phase IV Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222
This is a Phase IV real-world, observational, non-interventional, prospective cohort study of adults vaccinated with AZD1222. The purpose of this study is to assess the safety and tolerability of AZD1222 in adults vaccinated in real-world settings.
The study will use an innovative digital platform (study app and web portal) as well as a traditional call centre to collect participant responses to a series of health and well-being questionnaires over an 18-month period. Research coordinators at vaccination sites will invite vaccinated adults to join the study. Participants can enrol at the vaccination site with assistance from a research coordinator or can take home a study information brochure and enrol within 28 days after the first dose of AZD1222. Research coordinators and the study call centre will be available to assist with enrolment and informed consent, as needed. Electronic consent using the study app will be an option where permitted. Participants using the digital platform will set up a secure account, complete the enrolment questionnaires, and provide details of their vaccination to confirm eligibility. Non-digital participants will complete the enrolment questionnaires and confirm eligibility at a vaccination site or by a telephone call to the call centre. After enrolment, participants will be contacted to complete follow-up questionnaires at timed intervals over an 18-month period after their first AZD1222 dose. Digital participants will receive push notifications or emails and non-digital participants will receive phone calls. Participants can also submit unscheduled adverse event (AE) reports through the digital platform and call centre. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04516564 -
A Study of AK119 (Anti-CD73 Antibody), a Treatment for COVID-19, in Healthy Subjects
|
Phase 1 | |
| Withdrawn |
NCT04519424 -
CSL324 in COVID-19
|
Phase 2 | |
| Not yet recruiting |
NCT04395170 -
Convalescent Plasma (PC) and Human Intravenous Anti-COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19.
|
Phase 2/Phase 3 | |
| Completed |
NCT05437289 -
A Study to Evaluate the Safety and Tolerability of AZD7442 in Healthy Chinese Adults
|
Phase 1 | |
| Completed |
NCT05594147 -
An Observational Study, Called ROCURS, to Learn About COVID-19 Related Outcomes in People With Cancer Who Are Treated With Tyrosine Kinase Inhibitors (TKIs) Including Regorafenib or Sorafenib
|
||
| Withdrawn |
NCT04848467 -
COVID-19: A Trial Studying the SARS-CoV-2 mRNA Vaccine CVnCoV to Learn About the Immune Response, the Safety, and the Degree of Typical Vaccination Reactions When CVnCoV is Given at the Same Time as a Flu Vaccine Compared to When the Vaccines Are Separately Given in Adults 60 Years of Age and Older
|
Phase 3 | |
| Completed |
NCT04588363 -
COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C
|
||
| Completed |
NCT04742725 -
A Study to Evaluate the Efficacy and Safety of Prothione™ Capsules for Mild to Moderate Coronavirus Disease 2019 (COVID-19)
|
Phase 2 | |
| Completed |
NCT04545047 -
Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19
|
||
| Completed |
NCT04378777 -
Immunophenotyping Assessment in a COVID-19 Cohort
|
||
| Completed |
NCT04375761 -
COVID-19: Human Epidemiology and Response to SARS-CoV-2
|
||
| Completed |
NCT04327206 -
BCG Vaccination to Protect Healthcare Workers Against COVID-19
|
Phase 3 | |
| Terminated |
NCT05375760 -
A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19
|
Phase 2 | |
| Completed |
NCT04344977 -
Collection of Anti-SARS-CoV-2 Immune Plasma
|
||
| Terminated |
NCT04389840 -
Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure
|
Phase 2/Phase 3 | |
| Withdrawn |
NCT04425733 -
MK-5475 in Participants With Hypoxemia Due to COVID-19 Pneumonia (MK-5475-009)
|
Phase 1 | |
| Not yet recruiting |
NCT04438837 -
Hydroxychloroquine Post-Exposure Prophylaxis for Coronavirus Disease (COVID-19) Among Health-Care Workers
|
N/A | |
| Completed |
NCT04409509 -
Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID-19)
|
Phase 2 | |
| Completed |
NCT04275245 -
Clinical Study of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia
|
Phase 1/Phase 2 | |
| Terminated |
NCT04638634 -
Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
|
Phase 1 |