Bahmer, Thomas, Borzikowsky, Christoph, Lieb, Wolfgang, Horn, Anna, Krist, Lilian, Fricke, Julia, Scheibenbogen, Carmen, Rabe, Klaus F., Maetzler, Walter, Maetzler, Corina, Laudien, Martin, Frank, Derk, Ballhausen, Sabrina, Hermes, Anne, Miljukov, Olga, Haeusler, Karl Georg, El Mokhtari, Nour Eddine, Witzenrath, Martin, Vehreschild, Joerg Janne, Krefting, Dagmar, Pape, Daniel, Montellano, Felipe A., Kohls, Mirjam, Morbach, Caroline, Stork, Stefan, Reese, Jens-Peter, Keil, Thomas, Heuschmann, Peter, Krawczak, Michael, Schreiber, Stefanie, Bahmer, Thomas, Borzikowsky, Christoph, Lieb, Wolfgang, Horn, Anna, Krist, Lilian, Fricke, Julia, Scheibenbogen, Carmen, Rabe, Klaus F., Maetzler, Walter, Maetzler, Corina, Laudien, Martin, Frank, Derk, Ballhausen, Sabrina, Hermes, Anne, Miljukov, Olga, Haeusler, Karl Georg, El Mokhtari, Nour Eddine, Witzenrath, Martin, Vehreschild, Joerg Janne, Krefting, Dagmar, Pape, Daniel, Montellano, Felipe A., Kohls, Mirjam, Morbach, Caroline, Stork, Stefan, Reese, Jens-Peter, Keil, Thomas, Heuschmann, Peter, Krawczak, Michael, and Schreiber, Stefanie
Background Post-COVID syndrome (PCS) is an important sequela of COVID-19, characterised by symptom persistence for >3 months, post-acute symptom development, and worsening of pre-existing comorbidities. The causes and public health impact of PCS are still unclear, not least for the lack of efficient means to assess the presence and severity of PCS. Methods COVIDOM is a population-based cohort study of polymerase chain reaction (PCR) confirmed cases of SARS-CoV-2 infection, recruited through public health authorities in three German regions (Kiel, Berlin, Wurzburg) between November 15, 2020 and September 29, 2021. Main inclusion criteria were (i) a PCR confirmed SARS-CoV-2 infection and (ii) a period of at least 6 months between the infection and the visit to the COVIDOM study site. Other inclusion criteria were written informed consent and age = 18 years. Key exclusion criterion was an acute reinfection with SARS-CoV-2. Study site visits included standardised interviews, in-depth examination, and biomaterial procurement. In sub-cohort Kiel-I, a PCS (severity) score was developed based upon 12 long-term symptom complexes. Two validation sub-cohorts (Wurzburg/Berlin, Kiel-II) were used for PCS score replication and identification of clinically meaningful predictors. This study is registered at clinicaltrials.gov (NCT04679584) and at the German Registry for Clinical Studies (DRKS, DRKS00023742). Findings In Kiel-I (n = 667, 57% women), 90% of participants had received outpatient treatment for acute COVID-19. Neurological ailments (61.5%), fatigue (57.1%), and sleep disturbance (57.0%) were the most frequent persisting symptoms at 6-12 months after infection. Across sub-cohorts (Wurzburg/Berlin, n = 316, 52% women; Kiel-II, n = 459, 56% women), higher PCS scores were associated with lower health-related quality of life (EQ-5D-5L-VAS/-index: r = -0.54/ -0.56, all p < 0.0001). Severe, moderate, and mild/no PCS according to the individual participant's PCS score occurred i