U07.1
Conditions
Interventions
Group 1: Patients with mild to moderate COVID-19 and a recommendation for preventive treatment, following the current internal standard operating procedure (SOP) for treatment of COVID-19 patients of
Sponsors
Charité Universitätsmedizin Berlin, Klinik m.S. Infektiologie und Pneumologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Proven infection with SARS-CoV-2 (positive PCR testing) with mild to moderate symptoms according to WHO criteria. Symptoms since = 5 days or first positive SARS-CoV-2 PCR = 5 days. Treatment in ambulatory care or concomitant hospitalization for another medical condition. Ability and willingness to participate in the study. Recommendation for preventive treatment with antivirals and/or mABs according to the standard procedure within Charité - Universitätsmedizin Berlin due to present risk-factors for a severe course of COVID-19 (as currently defined by Robert-Koch institute) and one of the following conditions: not vaccinated or not completely vaccinated or high risk for vaccination failure according to the definition by Robert-Koch Institute.
Exclusion criteria
Exclusion criteria: Inability or unwillingness to provide informed consent. Any conditions that prohibits supplemental blood-sampling. Severe or critical COVID-19 with the need of oxygen supplementation (NIH definition: need of SpO2 30 breaths/min, or lung infiltrates >50% or in respiratory failure. Patients with planned or performed operation with intubation anestesia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients needing hospitalization due to aggravated COVID-19, proportion of patients needing intensive care and proportion of patients who die because of COVID-19 within 30 days after onset of symptoms (or first positive PCR in asymptomatic patients). | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographic characteristics of high-risk patients: Clinical characteristics (clinical presentation and pre-existing conditions) Comparison of multiple demographic, epidemiological and clinical data detailed in the eCRF in accordance with the published Pa-COVID-19 protocol (https://doi.org/10.1007/s15010-020-01464-x) and the German Corona Consensus Dataset (GECCO) Comparison of multiple laboratory parameters derived from routine laboratory Virological characteristics upon diagnosis and at follow up (first 2 weeks after diagnosis, week 4, month 6): Viral load in respiratory samples Determination of SARS-COV-2 variant and sublineage Viral genome sequencing in a subgroup of patients including mutations of the spike protein Immunological characteristics, including history of COVID-19 vaccination and previous infections upon diagnosis and at follow up (week 4, month 6): Serum IgG and IgA for: S, S1, RBD and N Serum neutralization (sVNT) for D614G and VOC spike T cell reactivity (Interferon gamma release assay, IGRA and flow cytometry) single-cell transcriptional profile of leukocyte populations in a subgroup plasma proteomic profile in a subgroup | — |
Countries
Germany
Contacts
Public ContactFlorian Kurth
Charité Universitätsmedizin Berlin, Klinik m.S. Infektiologie und Pneumologie
Outcome results
None listed