COVID-19 Respiratory Infection Clinical Trial
— CLEAROfficial title:
CLEAR: COVID-Like Illness Respiratory Pathogens - Diagnostics Response in Ghana. A Prospective Cohort on the COVID-19 Post-acute Condition
NCT number | NCT05047666 |
Other study ID # | CLEAR1.0 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 2021 |
Est. completion date | March 2023 |
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.
Status | Not yet recruiting |
Enrollment | 1232 |
Est. completion date | March 2023 |
Est. primary completion date | October 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Bernhard Nocht Institute for Tropical Medicine | Kumasi Centre for Collaborative Research (KCCR) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | Exploratory Endpoint 2 | Vaccine effectiveness in the subgroup of symptomatic PCR-positive SARS-CoV-2 patients using the test-negative design. | 13 months | |
Primary | Admissions and Outpatient encounter | Cumulated number of admissions and outpatient encounters within 13 months post PCR diagnosis | 13 months | |
Primary | Persistent or new symptoms | Cumulated number of persistent/new symptoms within 13 months post PCR diagnosis | 13 months | |
Primary | 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 | Patients' symptoms outcome | Occurrence of sequalae, post-acute symptoms and long-term patients' outcomes | 13 months | |
Secondary | Pathogen detection | Pathogens detected by PCR respiratory panel | 13 months |