SARS-CoV-2 Infection Clinical Trial
Official title:
Investigation of the Immune Response Before and After COVID-19 Disease or SARS-CoV-2 Vaccination in Dialysis Patients, Solid Organ Recipients and Medical Staff
To investigate short- (3 and 8 weeks) and long-term (6, 9, 12, and 18 months) immune protection or response at the humoral and cellular levels before and after SARS-CoV-2 infection or vaccination in patients with moderately reduced immune status (dialysis patients) and severely reduced immune status (organ transplant recipients, mostly kidney transplant recipients) and immunocompetent subjects (medical staff) in Saxony, Germany.
- Formation of two separate cohorts of approximately 1000 study subjects each from the three categories (dialysis patients, solid organ transplant recipients and medical staff) of participants vaccinated using either Biontech or Moderna vaccine (Biontech cohort and Moderna cohort, approximately 2000 subjects total). - Study time points: Before administration of the 1st SARS-CoV-2 vaccine dose, before the 2nd vaccine dose, and 8 weeks and 6, 9, 12, and 18 months after administration of the 1st vaccine dose and after suspected or proven SARS-CoV-2 infection. - At all time points, a questionnaire or eCRF will be completed with questions about the dialysis center and the clinical course of the patients. - Humoral immune response will be determined in all study participants. - Formation of a study subgroup of up to 300 subjects in each cohort (Biontech or Moderna cohort) for detailed evaluation of the cellular immune response (max. 600 subjects in total). - In case of non-sustained immunity > 6 months as well as the occurrence of a 3rd SARS-CoV-2 infection wave in autumn 2021, this will be investigated analogously to the current wave. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04555096 -
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
|
Phase 2 | |
| Completed |
NCT04593641 -
This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)
|
Phase 1 | |
| Recruiting |
NCT05200754 -
Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19
|
Phase 2 | |
| Completed |
NCT04583995 -
A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom
|
Phase 3 | |
| Recruiting |
NCT06255860 -
SARS-COV-2 Reinfection and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk: Matched Case-control Study
|
||
| Recruiting |
NCT04516811 -
Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19
|
Phase 3 | |
| Recruiting |
NCT05012826 -
Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID
|
N/A | |
| Completed |
NCT05007236 -
Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection.
|
Phase 2 | |
| Recruiting |
NCT06026514 -
Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults
|
Phase 1 | |
| Completed |
NCT05523739 -
Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients
|
Phase 1 | |
| Suspended |
NCT04738136 -
Safety, Tolerability and Efficacy Of S-1226 in Moderate Severity Covid-19 Bronchiolitis/Pneumonia
|
Phase 2 | |
| Recruiting |
NCT04584658 -
Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)
|
||
| Recruiting |
NCT04547114 -
Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects
|
||
| Completed |
NCT05119348 -
Transmission of Coronavirus Disease 2019 (COVID19) in Crowded Environments
|
N/A | |
| Completed |
NCT05096962 -
COVID-19: SARS-CoV-2-CZ-PREVAL-II Study
|
||
| Recruiting |
NCT04534400 -
Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure
|
||
| Completed |
NCT04527354 -
Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia
|
Phase 2 | |
| Completed |
NCT04583982 -
ImmuneSense™ COVID-19 Study
|
||
| Completed |
NCT05077176 -
Phase 3 Booster Vaccination Against COVID-19
|
Phase 3 | |
| Completed |
NCT05584189 -
COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability
|
N/A |