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

CLEAR: COVID-Like Illness Respiratory Pathogens - Diagnostics Response in Ghana. A Prospective Cohort on the COVID-19 Post-acute Condition

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19 Respiratory Infection; Respiratory Infection; Sequelae of; Infection

Detailed Description

This is an observational prospective matched cohort study to evaluate the post-acute consequences of the SARS-CoV-2 symptomatic infection (case-positives) while having as comparison groups (1) symptomatic controls (case-negatives) and (2) healthy controls, that are healthy individuals recruited from the same community of the cases, but not arise from the same household. After pre-screening of COVID-19 symptoms at the hospital and other satellite health centers, consenting/assenting patients of 16 years of age and above with all range of PCR-confirmed Covid-19 disease severity -from mild to severely ill hospitalized patients- will be recruited and matched to other Non-SARS-CoV-2 PCR-determined patients and to healthy community controls. Then, they will be followed up for 12 months (13 months after screening) to determine the occurrence of admissions, any outpatient encounter, symptoms (new or persistent) and concomitant use of medication after 28 days of diagnosis.

At recruitment, respiratory samples are collected for respiratory infections diagnosis. Also, blood samples are collected to generate baseline data on potential biomarkers associated to occurrence of investigated outcomes. This will include biochemistry (including inflammatory markers) and hematology as well as SARS-CoV-2 serology (IgG) which will also be taken at the end of follow up to rule out infection during the course of the follow up. Though, the serology testing won't be done along each recruitment but in batches during the study period. Clinical (symptoms and diagnosis), socioeconomic, demographic, household conditions, health seeking behavior and medical history information will be gathered.

• Study Type: Observational
• Enrollment (Anticipated): 1232

Contacts and Locations

• Study Contact: Name: Ricardo Strauss, Dr. MD. MPH; Phone Number: +49 40 42818 243; Email: ricardo.strauss@bnitm.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

1. For symptomatic patients attending to the SFXH or other satellite health centers

   • Inclusion Criteria

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

   • Exclusion Criteria

     1. Symptomatic patients who test negative for all pathogens of the PCR-based respiratory panel.
     2. 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)

2. Antimicrobial Use Work package (A subset of hospitalized, symptomatic patients are to be recruited as control group for the Antimicrobial Use Workpackage, if they meet the inclusion criteria)

   • Inclusion Criteria

     1. Patients > or =16 years of age
     2. Presenting respiratory symptoms
     3. Negative respiratory sample for SARS-CoV-2 (RDT)
     4. Do not meet the matching criteria (age and residency (community)) as symptomatic controls to any of the recruited cases
     5. Admitted to SFXH
     6. Consented participation

3. For healthy controls from the community

   • Inclusion Criteria

     1. Patients > or =16 years of age
     2. Meet the age and residency (community) criteria to be matched to the cases
     3. Possibility to be contacted during follow-up
     4. Consented participation

   • Exclusion Criteria

     1. Presenting COVID-19 like symptoms
     2. Positive for SARS-CoV-2 RDT Eligible participants in the community presenting with an acute illness can be considered for inclusion as a case and recommended for referral to SFXH/ satellite health centre.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Average weekly intake of particular medication(s); Newly use of a particular medication(s)	13 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' symptoms outcome	Occurrence of sequalae, post-acute symptoms and long-term patients' outcomes	13 months
Pathogen detection	Pathogens detected by PCR respiratory panel	13 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Endpoint 1	Viral variants detection via sequencing in the subgroup of symptomatic PCR-positive SARS-CoV-2 patients using the test-negative design.	13 months
Exploratory Endpoint 2	Vaccine effectiveness in the subgroup of symptomatic PCR-positive SARS-CoV-2 patients using the test-negative design.	13 months

Collaborators and Investigators

• Sponsor: Bernhard Nocht Institute for Tropical Medicine
• Collaborators: Kumasi Centre for Collaborative Research (KCCR)
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2021
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (ACTUAL): September 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: CLEAR1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No