Assessment of clinical, virological and immunological characteristics in high-risk COVID-19 patients with mild to moderate symptoms – a non-interventional cohort study

Recruiting

• Conditions: U07.1; COVID-19, virus identified

• Registration Number: DRKS00031503
• Lead Sponsor: Charité Universitätsmedizin Berlin, Klinik m.S. Infektiologie und Pneumologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 225

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

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 <94% on room air, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg, a respiratory rate >30 breaths/min, or lung infiltrates >50% or in respiratory failure.

Patients with planned or performed operation with intubation anestesia.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).