COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04387409

Leander Grode

grode@vakzine-manager.de

2020-05-13

Unknown

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: - adult (≥18 years) - male or female - hospital personnel with expected high sars-cov-2 exposure - subject is contractually capable, able to understand information on study and has signed informed consent sheet - subject has access to an internet-enabled electronic device - women of childbearing potential who are currently using reliable methods of birth control, have a negative pregnancy test during screening and have no intention to become pregnant for at least 3 months post-vaccination.

known hypersensitivity or allergy to (components of) the vpm1002 vaccine or serious adverse reactions to prior bcg administration known active or latent mycobacterium tuberculosis infection or with another mycobacterial species. a history with or suspicion of m. tuberculosis infection. fever (>38 °c) within the past 24 hours pregnant or breast-feeding suspicion of active viral or bacterial infection participation of subject in another study within 30 days before screening and during this study person is an employee of the sponsor, a relative of the investigator or in direct reporting line to clinical trial staff at the clinical trial site severely immunocompromised subjects, such as: subjects with known infection with the human immunodeficiency virus (hiv); subjects with solid organ transplantation; subjects with bone marrow transplantation; subjects under chemotherapy, immunotherapy and radiotherapy; subjects with primary immunodeficiency; treatment with any anti-cytokine therapies; treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months active solid or non-solid malignancy or lymphoma in the past 5 years direct involvement in the design or the execution of the present clinical trial expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc) employed to the hospital < 22 hours per week previous positive sars-cov-2 test result

2

Vakzine Projekt Management GmbH

18

100

Germany

Close contacts to covid patients

N/A

59

Number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection)

None

Phase 3

[{"arm_notes": "1;results available for 2020-001376-15 on : https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001376-15/results", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "1;results available for 2020-001376-15 on : https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001376-15/results", "treatment_id": 1378, "treatment_name": "Vpm1002", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]