EUCTR2020-005915-39-IT进行中（未招募）1 期
COVID-19 A Phase II/III, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of GRAd-COV2 Vaccine in Adults Aged 18 Years and Older - COVITAR
REITHERA SR0 个研究点目标入组 10,000 人开始时间: 2021年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adult female and male, 18 years of age or older at the time of consent
- •2. Medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol-specified follow-up. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrollment
- •3. Able to understand and comply with study requirements/procedures based on the assessment of the investigator
- •4. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •5. Female participants, (a) Women of childbearing potential must: Have a negative pregnancy test on the day of screening and on Day 1; use one highly effective form of birth control for at least 28 days prior to Day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of study intervention.
- •6. Capable of giving signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2500
排除标准
- •1. History of allergy to any component of the vaccine
- •2. History of Guillain-Barré syndrome or any other demyelinating condition
- •3. Significant infection or other acute illness, including fever > 37.3 °C on the day prior to or day of randomization
- •4. History of laboratory-confirmed SARS-CoV-2 infection
- •5. Any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia (only for phase II)
- •6. Recurrent severe infections and use of immunosuppressant medication within the past 6 months
- •7. History of primary malignancy except for: (a) Malignancy with low potential risk for recurrence after curative treatment (for example, history of childhood leukaemia) or metastasis (for example, indolent prostate cancer) in the opinion of the site investigator. (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (c) Adequately treated uterine cervical carcinoma in situ without evidence of disease (d) Localized prostate cancer (only for phase II)
- •8. Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or vene puncture
- •9. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness, as judged by the Investigator (mild/moderate well-controlled comorbidities are allowed) (only for phase II)
- •10. Any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data
- •11. Receipt of, or planned receipt of investigational or licensed products indicated for the treatment or prevention of SARS-CoV-2 or COVID-19
- •12. Receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines within 30 days prior to and after administration of study intervention
- •13. Receipt of immunoglobulins and/or any blood products within 3 months prior to administration of study intervention or expected receipt during the period of study follow-up
- •14. Involvement in the planning and/or conduct of this study (applies to both Sponsor staff and/or staff at the study site)
- •15. For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding
- •16. Has donated 450 ml or more of blood products within 30 days prior to randomization or expects to donate blood within 90 days of administration of study intervention.
研究者
相似试验
进行中（未招募）
1 期
Safety and Immunogenicity of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adult Health Care Workers in Mainz (Germany)Vaccination for prophylaxis of COVID-19 (healthy adults)MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865EUCTR2020-004066-19-DECureVac AG2,520
招募中
不适用
HERALDPER-106-20CureVac AG,7,448
尚未招募
3 期
COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older.NL-OMON50925CureVac AG2,400
进行中（未招募）
1 期
Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and OlderVaccination for prophylaxis of COVID-19 (healthy adults)MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865EUCTR2020-003998-22-BECureVac AG36,500
进行中（未招募）
1 期
Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and OlderVaccination for prophylaxis of COVID-19 (healthy adults)MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865EUCTR2020-003998-22-DECureVac AG36,500