Respiratory InfectionCLEARNCT05047666
COVID-Like Illness Respiratory Pathogens. A Prospective Cohort on the COVID-19 Post-acute Condition
An observational study of Respiratory Infection and COVID-19 Respiratory Infection, run by Bernhard Nocht Institute for Tropical Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Respiratory Infection, COVID-19 Respiratory Infection, Sequelae of; Infection
- How many people
- 1,232 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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)
- 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)
- Presenting COVID-19 like symptoms
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Medical subject headings
- Respiratory Tract Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Admissions and Outpatient encounter
Cumulated number of admissions and outpatient encounters within 13 months post PCR diagnosis
Measured: 13 months
Persistent or new symptoms
Cumulated number of persistent/new symptoms within 13 months post PCR diagnosis
Measured: 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)
Measured: 13 months
Secondary outcomes (2)
Patients' symptoms outcome
Occurrence of sequalae, post-acute symptoms and long-term patients' outcomes
Measured: 13 months
Pathogen detection
Pathogens detected by PCR respiratory panel
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bernhard Nocht Institute for Tropical Medicine
- Sponsor type
- Other government
- Collaborators
- Kumasi Centre for Collaborative Research (KCCR)
- Responsible party
- Sponsor
- Investigators
- Ricardo Strauss, Dr.MD. MPH, Principal investigator, Bernhard Nocht Institute for Tropical MedicineJürgen May, Prof. Dr., Principal investigator, Bernhard Nocht Institute for Tropical MedicineOumou Maiga-Ascofare, PhD, Principal investigator, Kumasi Center for Collaborative Research in Tropical MedicineJohn Amuasi, MBChB, MPH, PhD, Principal investigator, Kumasi Center for Collaborative Research in Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047666
- Sponsor's protocol ID
- CLEAR1.0
- Acronym
- CLEAR
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLEAR: COVID-Like Illness Respiratory Pathogens - Diagnostics Response in Ghana. A Prospective Cohort on the COVID-19 Post-acute Condition
- ClinicalTrials.gov ID
- NCT05047666
- Acronym / sponsor ID
- CLEAR / CLEAR1.0
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,232 participants (estimated)
- Lead sponsor
- Bernhard Nocht Institute for Tropical MedicineOther government
- Collaborators
- Kumasi Centre for Collaborative Research (KCCR)
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (17 listed)
- For healthy controls from the community
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Admissions and Outpatient encounter
Time frame: 13 months
Cumulated number of admissions and outpatient encounters within 13 months post PCR diagnosis
Persistent or new symptoms
Time frame: 13 months
Cumulated number of persistent/new symptoms within 13 months post PCR diagnosis
Medication and therapy
Time frame: 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)
2 secondary outcomes
Patients' symptoms outcome
Time frame: 13 months
Pathogen detection
Time frame: 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Strauss, Dr.MD. MPH principal investigator
Bernhard Nocht Institute for Tropical Medicine
Jürgen May, Prof. Dr. principal investigator
Bernhard Nocht Institute for Tropical Medicine
Oumou Maiga-Ascofare, PhD principal investigator
Kumasi Center for Collaborative Research in Tropical Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Infection and COVID-19 Respiratory Infection, run by Bernhard Nocht Institute for Tropical Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Strauss, Dr. MD. MPH (+49 40 42818 243, ricardo.strauss@bnitm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admissions and Outpatient encounter (time frame: 13 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.