Funded by the pharmaceutical industry
Vakzine Projekt Management GmbH
Department / Institute: MHH CRC Core Facility / Clinical Trial Unit
VPM1002, a recombinant BCG-vaccine containing Mycobacterium bovis (rBCGΔureC::hly) as an active incredient, standardized to the number of viable mycobacteria (CFU) per application is investigated in this phase III, randomized, double-blind, placebo-controlled, multicentre, clinical trial. Efficacy and safety of VPM1002 will be assessed in reducing hospital admissions and/or severe respiratory infectious diseases in elderly during the SARS-CoV-2 pandemic by modulating the immune system. The primary objective is to assess the reduction of days with severe respiratory infectious diseases at hospital and/or at home in elderly subjects during the pandemic of SARS-CoV-2. The secondary objective is to assess the reduction of disease severity, the duration of hospital admission,
intensive care unit (ICU) admission, or death in elderly subjects during the pandemic of SARS-CoV-2. The Coordinating trial centre is Medizinische Hochschule Hannover (MHH), Clinical Research Centre Hannover together with up to 13 additional centres in Germany.
FGK Clinical Research GmbH
Department / Institute: MHH CRC Core Facility / Clinical Trial Unit (OE 8660)
VPM1002, a recombinant BCG-vaccine containing Mycobacterium bovis (rBCGΔureC::hly) as an active incredient and standardized to the number of viable mycobacteria (CFU) per application is investigated in a phase III, randomized, double-blind, placebo-controlled, multicentre, clinical trial to assess the efficacy and safety in reducing healthcare professionals’ absenteeism in the SARS-CoV-2 pandemic by modulating the immune system. The primary objective is to assess the reduction of absenteeism among healthcare professionals with direct patient contacts during the pandemic phase of COVID-19. The secondary objective is to assess the incidence of SARS-CoV-2 symptoms of infection, reduction of hospital admission, intensive care unit (ICU) admission or death in healthcare professionals with direct patient contacts during the pandemic phase of COVID-19. The coordinating trial centre is Medizinische Hochschule Hannover (MHH), Clinical Research Centre Hannover and up to 5 additional centres are planned in Germany.
Novartis Pharma GmbH Nürnberg
Department / Institute: Rheumatology and Immunology, Pediatric Pneumology
The COVID-19 Contact (CoCo) Study at Hannover Medical School (MHH) prospectively analyses seroconversion against SARS-CoV2 in health care professionals (HCP) of MHH and affiliated partner sites.
A first cohort, CoCo 1.0, was established in March 2020 and analyses COVID-19 specific immune responses and questionnaire based information on infection risk and risk perception in weekly to monthly intervals in 200 HCP of the MHH team. This cohort also includes a subset of individuals with confirmed COVID-19 infection.
Our second cohot (CoCo 2.0) is larger and comprises more than 1000 probands, applying similar techniques and a variable, risk-adapted testing strategy.
The CoCo study will generate important information on the risk of HCP during the current pandemic, on the value of serological screening techniques in this context; and on longitudinal immune responses against SARS-CoV-2.
Boehringer Ingelheim Pharma GmbH & Co. KG
Department / Institute: Department of Pneumology
A Phase IIb/III operationally seamless, open-label, randomised, sequential, parallel-group adaptive study to evaluate the efficacy and safety of daily intravenous alteplase treatment given up to 5 days on top of standard of care (SOC) compared with SOC alone, in patients with acute respiratory distress syndrome (ARDS) triggered by COVID-19.
GlaxoSmithKline R&D Limited
Department / Institute: Department of Pneumology
A randomized, double-blind, placebo-controlled, study evaluating the efficacy and safety of otilimab IV in patients (≥ 70 years) with severe pulmonary COVID-19 related disease (EudraCT: 2020-001759-42).
InflaRx GmbH Jena
Department / Institute: Department of Pneumology
A pragmatic adaptive randomized controlled Phase II/III multicenter Study of IFX-1 in Patients with severe COVID-19 Pneumonia (EudraCT Number: 2020-001335-28).