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

• Conditions: Respiratory Infection; COVID-19 Respiratory Infection; Sequelae of; Infection

• Registration Number: NCT05047666
• Lead Sponsor: Bernhard Nocht Institute for Tropical Medicine

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.

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 Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-14
• Last Update Submitted: 2021-09-14
• Study First Posted: 2021-09-17
• Last Update Posted: 2021-09-17
• Study Start: 2021-10
• Primary Completion: 2022-10
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1232

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Admissions and Outpatient encounter	13 months	Cumulated number of admissions and outpatient encounters within 13 months post PCR diagnosis
Persistent or new symptoms	13 months	Cumulated number of persistent/new symptoms within 13 months post PCR diagnosis
Medication and therapy	13 months	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)

Secondary Outcome Measures

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