COVID-Like Illness Respiratory Pathogens. A Prospective Cohort on the COVID-19 Post-acute Condition

NCT05047666 | Unknown

• 1 other identifier: CLEAR1.0
• Study Type: observational
• Target: 1,232
• Locations: 0 countries
• Sites: N/A

Brief Summary

Identifying multiorgan sequalae and complications through high quality, prospective matched controlled studies throughout the course of COVID-19 is important for the acute and long-term management of patients and for health systems' planning. Further, it is key to understand the link between acute illness and long term consequences particularly in those already living with other comorbidities such as cardiovascular diseases or cancer. Since the clinical presentation of COVID-19 can resemble a variety of common respiratory infections, describing the distribution of pathogens and the severity of clinical presentation associated with COVID-like illnesses (CLI) infections is important to generate a baseline clinical description by comparing potential long-term effects of PCR-confirmed COVID-19 to those following other respiratory infections. To gain a better understanding of the clinical burden on COVID-19 survivors we will undertake a comparative evaluation within a cohort of PCR-confirmed individuals with COVID-19 vs. those PCR-confirmed symptomatic individuals with other respiratory pathogens plus healthy individuals from the community. The results will inform strategies to prevent long term consequences; inform clinical management, interventional research, direct rehabilitation, and inform public health management to reduce overall morbidity and improve outcomes of COVID-19.

Conditions

Respiratory Infection; COVID-19 Respiratory Infection; Sequelae of; Infection

Outcome Measures

Primary Outcomes (3)

• Admissions and Outpatient encounter

  Cumulated number of admissions and outpatient encounters within 13 months post PCR diagnosis

  13 months

• Persistent or new symptoms

  Cumulated number of persistent/new symptoms within 13 months post PCR diagnosis

  13 months

• Medication and therapy

  Cumulated therapy and use within 13 months post PCR diagnosis defined as: 1. Average weekly intake of particular medication(s) 2. Newly use of a particular medication(s)

  13 months

Secondary Outcomes (2)

• Patients' symptoms outcome

  13 months

• Pathogen detection

  13 months

Other Outcomes (2)

• Exploratory Endpoint 1

  13 months

• Exploratory Endpoint 2

  13 months

Study Arms (3)

Cases Group

Also called in our study 'Case-Positives'. These are those with respiratory symptoms suspected of COVID-19 that actually test positive (PCR).

Symptomatic Control Group

Also called in our study 'Case-Negatives'. These are those with respiratory symptoms suspected of COVID-19 that actually test negative for SARS-CoV-2 but positive for any other pathogen included in our respiratory PCR-based panel.

Healthy Control Group

At the community.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study takes place in Assin Foso, Assin North District, Ghana. This is a semi rural area. Participants are recruited from the Saint Francis Xavier Hospital, the reference center of the region, when the seek for health services due to respiratory symptoms. Healthy controls are recruited from the communities from where cases arise.

You may qualify if:

• Patients \> or =16 years of age
• Presenting respiratory symptoms
• Positive respiratory sample for SARS-CoV-2 or other respiratory infections included in the panel
• Possibility to be contacted during follow-up
• Consented participation
• Patients which households are located within the study catchment area

You may not qualify if:

• Symptomatic patients who test negative for all pathogens of the PCR-based respiratory panel.
• Symptomatic patients who test negative for the SARS-CoV-2 RDT and do not meet the matching criteria (age and residency (community)) as symptomatic controls to any of the recruited cases (to be considered as controls for the Antimicrobial Use Workpackage)
• Patients \> or =16 years of age
• Presenting respiratory symptoms
• Negative respiratory sample for SARS-CoV-2 (RDT)
• Do not meet the matching criteria (age and residency (community)) as symptomatic controls to any of the recruited cases
• Admitted to SFXH
• Consented participation
• For healthy controls from the community
• Patients \> or =16 years of age
• Meet the age and residency (community) criteria to be matched to the cases
• Possibility to be contacted during follow-up
• Consented participation
• Presenting COVID-19 like symptoms

Sponsors & Collaborators

• Bernhard Nocht Institute for Tropical Medicine: lead
• Kumasi Centre for Collaborative Research (KCCR): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Respiratory samples (PCR), Blood Samples (Hematology, Biochemistry, Serology)

MeSH Terms

Conditions

Respiratory Tract Infections; Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Ricardo Strauss, Dr.MD. MPH

  Bernhard Nocht Institute for Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Jürgen May, Prof. Dr.

  Bernhard Nocht Institute for Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Oumou Maiga-Ascofare, PhD

  Kumasi Center for Collaborative Research in Tropical Medicine

  PRINCIPAL INVESTIGATOR

• John Amuasi, MBChB, MPH, PhD

  Kumasi Center for Collaborative Research in Tropical Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo Strauss, Dr. MD. MPH

CONTACT

+49 40 42818 243; ricardo.strauss@bnitm.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 17, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: March 1, 2023
• Last Updated: September 17, 2021

Record last verified: 2021-09