COVID-19 PneumoniaCOVISERANCT05274373
Clinical, Virological, Serological and Immunological Characteristics During and Following COVID-19 Hospitalization
An observational study of COVID-19 Pneumonia and COVID-19, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
Assessment of the association between the severity of COVID-19 and SARS-CoV-2 NAb titers levels for up to six months following primary infection using a live virus NAb assay. Description of SARS-CoV-2 viral shedding and infectiousness during the first 30 days after infection in a group of unvaccinated hospitalized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia, COVID-19
- How many people
- 47 participants
- Where
- 1 siteDenmark
- Study dates
- 24 May 2020to 1 Oct 2023
- How long will I take part?
- 6 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult unvaccinated hospitalized patients
Who may be able to join
- positive SARS-CoV-2 specimen from upper or lower respiratory tracts (virological criteria)
- consolidations on the chest X-ray described by a radiologist, treating physician or a physician from the study group (radiological criteria)
- the presence of one or more of the following: fever (temperature ≥38.0°C), new-onset cough, pleuritic chest pain, dyspnea or altered breath sounds on auscultation (clinical criteria)
Who cannot join
- cognitive impairment prohibiting giving informed consent to participation
- by December 14th, 2020, and onwards patients if the time since symptom onset was > seven days at the time of inclusion
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital at North Zealand
Copenhagen, 25482
About this study
Official title: Clinical, Virological, Serological and Immunological Characteristics During and Following COVID-19 Hospitalization: a Prospective Cohort Study
Assessment of the association between the severity of COVID-19 and SARS-CoV-2 NAb titers levels for up to six months following primary infection using a live virus NAb assay. Description of SARS-CoV-2 viral shedding and infectiousness during the first 30 days after infection in a group of unvaccinated hospitalized patients.
Read the detailed description
The studys primary aim is to assess clinical factors, such as disease severity, associated with neutralizing antibody (NAb) production. Furthermore, the study aims to assess the length of SARS-CoV-2 infectiousness and clinical factors associated with viral load.
Patients 18 years or older hospitalized at Copenhagen University Hospital at North Zealand, Copenhagen, Denmark, May 24th,2020 - May 5th, 2021, were routinely screened for COVID-19 by diagnostic oropharyngeal or tracheal RT-PCR samples taken during admission. Patients with a positive SARS-CoV-2 PCR within 48 hours from hospital admission were offered inclusion, if COVID-19 pneumonia was confirmed.
The following were retrieved from patients' electronic records: comorbidities (Charlson Comorbidity Index),vital signs (Early Warning Score), immunocompromised status, time from symptom onset to admission, oxygen treatment, pharmacological treatment, admission length, death and bacterial co-infection.
Paired oropharyngeal swabs and serum samples were collected at inclusion (day 0), days 3, 7, 10, 14, 17, 24, and 30. Serum samples were, if possible, also collected after three and six months. Follow-up time was six months.
RT-qPCR analysis targeted the SARS-CoV-2 RNA-dependent-RNA-polymerase (RdRp)-helicase gene region and two samples with known viral load were included in each PCR-run for quantification of patient samples. Virus was cultured in African green monkey cells (VERO-E6) with incubation for 3 - 4 days and daily microscopic inspection for cytopathogenic effect (CPE). A total of three passages were made before the the virus was interpreted as non-replicant. Cells with CPE were confirmed by RT-qPCR.
The presence of specific antibodies (Ab) against SARS-CoV-2 in serum was assessed using Wantai total-Ab ELISA according to the manufacturer's instructions (Wantai, Beijing, China).
For the in-house live virus NAb analysis, a 50% cut-off value was calculated from quadruplicate virus and cell control wells included on each plate using the following equation: (average optical density (OD) of virus control wells + average OD of cell control wells)/2. The 50% neutralization titer was calculated as the interpolation of the cutoff value with a four-parameter logistic regression curve fitted for each serum serial dilution. To minimize inter-assay variation, the titers were normalized according to a positive control included on each assay plate.
A linear mxied-effects model was used to assess the association between repeated NAb measurements and clinical variables such as age, gender and disease severity. A linear mixed-effects model was also used to assess the association between repeated viral load measurements and clinical variables.
- Conditions
- COVID-19 Pneumonia, COVID-19
- Keywords
- Neutralizing Antibodies, Viral Load, Antibody Decay, Viral Culturing, Infectiousness
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing Antibody Titer - Day 0
Baseline Log10 Spike protein neutralizing antibody titer
Measured: Day 0
Change from baseline in Neutralizing Antibody Titer - Day 30
Log10 Spike protein neutralizing antibody titer
Measured: Day 30
Change from baseline in Neutralizing Antibody Titer - Day 90
Log10 Spike protein neutralizing antibody titer
Measured: Day 90
Change from baseline in Neutralizing Antibody Titer- Day 180
Log10 Spike protein neutralizing antibody titer
Measured: Day 180
Viral culturing - Day 0
Number of successful viral culturing attempts (SARS-CoV-2)
Measured: Day 0
Viral culturing - Day 3
Number of successful viral culturing attempts (SARS-CoV-2)
Measured: Day 3
Viral culturing - Day 7
Number of successful viral culturing attempts (SARS-CoV-2)
Measured: Day 7
Viral culturing - Day 10
Number of successful viral culturing attempts (SARS-CoV-2)
Measured: Day 10
Viral culturing - Day 14
Number of successful viral culturing attempts (SARS-CoV-2)
Measured: Day 14
Viral culturing - Day 17
Number of successful viral culturing attempts (SARS-CoV-2)
Measured: Day 17
Viral culturing - Day 24
Number of successful viral culturing attempts (SARS-CoV-2)
Measured: Day 24
Viral culturing - Day 30
Number of successful viral culturing attempts (SARS-CoV-2)
Measured: Day 30
Secondary outcomes (8)
Baseline Viral Load - Day 0
Log10 copies/ml
Measured: Day 0
Change from Baseline Viral Load - Day 3
Log10 copies/ml
Measured: Day 3
Change from Baseline Viral Load - Day 7
Log10 copies/ml
Measured: Day 7
Change from Baseline Viral Load - Day 10
Log10 copies/ml
Measured: Day 10
Change from Baseline Viral Load - Day 14
Log10 copies/ml
Measured: Day 14
Change from Baseline Viral Load - Day 17
Log10 copies/ml
Measured: Day 17
Change from Baseline Viral Load - Day 24
Log10 copies/ml
Measured: Day 24
Change from Baseline Viral Load - Day 30
Log10 copies/ml
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start24 May 2020
- Primary completion5 May 2021
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies 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
- 47 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Zitta Barrella Harboe, MD, PhD, Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274373
- Sponsor's protocol ID
- Covisera
- Acronym
- COVISERA
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sejdic A, Frische A, Jorgensen CS, Rasmussen LD, Trebbien R, Dungu A, Holler JG, Ostrowski SR, Eriksson R, Soborg C, Nielsen TL, Fischer TK, Lindegaard B, Franck KT, Harboe ZB. High titers of neutralizing SARS-CoV-2 antibodies six months after symptom onset are associated with increased severity in COVID-19 hospitalized patients. Virol J. 2023 Jan 25;20(1):14. doi: 10.1186/s12985-023-01974-8.
PubMed 36698135
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Virological, Serological and Immunological Characteristics During and Following COVID-19 Hospitalization: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05274373
- Acronym / sponsor ID
- COVISERA / Covisera
- Conditions
- COVID-19 Pneumonia, COVID-19
- Keywords
- Neutralizing Antibodies, Viral Load, Antibody Decay, Viral Culturing, Infectiousness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Statens Serum Institut, Copenhagen University Hospital, Rigshospitalet
- Study start
- 24 May 2020 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 10 Mar 2022 (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.
Assessment of the association between the severity of COVID-19 and SARS-CoV-2 NAb titers levels for up to six months following primary infection using a live virus NAb assay. Description of SARS-CoV-2 viral shedding and infectiousness during the first 30 days after infection in a group of unvaccinated hospitalized patients.
Detailed description
The studys primary aim is to assess clinical factors, such as disease severity, associated with neutralizing antibody (NAb) production. Furthermore, the study aims to assess the length of SARS-CoV-2 infectiousness and clinical factors associated with viral load.
Patients 18 years or older hospitalized at Copenhagen University Hospital at North Zealand, Copenhagen, Denmark, May 24th,2020 - May 5th, 2021, were routinely screened for COVID-19 by diagnostic oropharyngeal or tracheal RT-PCR samples taken during admission. Patients with a positive SARS-CoV-2 PCR within 48 hours from hospital admission were offered inclusion, if COVID-19 pneumonia was confirmed.
The following were retrieved from patients' electronic records: comorbidities (Charlson Comorbidity Index),vital signs (Early Warning Score), immunocompromised status, time from symptom onset to admission, oxygen treatment, pharmacological treatment, admission length, death and bacterial co-infection.
Paired oropharyngeal swabs and serum samples were collected at inclusion (day 0), days 3, 7, 10, 14, 17, 24, and 30. Serum samples were, if possible, also collected after three and six months. Follow-up time was six months.
RT-qPCR analysis targeted the SARS-CoV-2 RNA-dependent-RNA-polymerase (RdRp)-helicase gene region and two samples with known viral load were included in each PCR-run for quantification of patient samples. Virus was cultured in African green monkey cells (VERO-E6) with incubation for 3 - 4 days and daily microscopic inspection for cytopathogenic effect (CPE). A total of three passages were made before the the virus was interpreted as non-replicant. Cells with CPE were confirmed by RT-qPCR.
The presence of specific antibodies (Ab) against SARS-CoV-2 in serum was assessed using Wantai total-Ab ELISA according to the manufacturer's instructions (Wantai, Beijing, China).
For the in-house live virus NAb analysis, a 50% cut-off value was calculated from quadruplicate virus and cell control wells included on each plate using the following equation: (average optical density (OD) of virus control wells + average OD of cell control wells)/2. The 50% neutralization titer was calculated as the interpolation of the cutoff value with a four-parameter logistic regression curve fitted for each serum serial dilution. To minimize inter-assay variation, the titers were normalized according to a positive control included on each assay plate.
A linear mxied-effects model was used to assess the association between repeated NAb measurements and clinical variables such as age, gender and disease severity. A linear mixed-effects model was also used to assess the association between repeated viral load measurements and clinical variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult unvaccinated hospitalized patients
Key inclusion criteria (3 listed)
- positive SARS-CoV-2 specimen from upper or lower respiratory tracts (virological criteria)
- consolidations on the chest X-ray described by a radiologist, treating physician or a physician from the study group (radiological criteria)
- the presence of one or more of the following: fever (temperature ≥38.0°C), new-onset cough, pleuritic chest pain, dyspnea or altered breath sounds on auscultation (clinical criteria)
Key exclusion criteria (2 listed)
- cognitive impairment prohibiting giving informed consent to participation
- by December 14th, 2020, and onwards patients if the time since symptom onset was > seven days at the time of inclusion
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
Neutralizing Antibody Titer - Day 0
Time frame: Day 0
Baseline Log10 Spike protein neutralizing antibody titer
Change from baseline in Neutralizing Antibody Titer - Day 30
Time frame: Day 30
Log10 Spike protein neutralizing antibody titer
Change from baseline in Neutralizing Antibody Titer - Day 90
Time frame: Day 90
Log10 Spike protein neutralizing antibody titer
Change from baseline in Neutralizing Antibody Titer- Day 180
Time frame: Day 180
Log10 Spike protein neutralizing antibody titer
Viral culturing - Day 0
Time frame: Day 0
Number of successful viral culturing attempts (SARS-CoV-2)
Viral culturing - Day 3
Time frame: Day 3
Number of successful viral culturing attempts (SARS-CoV-2)
Viral culturing - Day 7
Time frame: Day 7
Number of successful viral culturing attempts (SARS-CoV-2)
Viral culturing - Day 10
Time frame: Day 10
Number of successful viral culturing attempts (SARS-CoV-2)
Viral culturing - Day 14
Time frame: Day 14
Number of successful viral culturing attempts (SARS-CoV-2)
Viral culturing - Day 17
Time frame: Day 17
Number of successful viral culturing attempts (SARS-CoV-2)
Viral culturing - Day 24
Time frame: Day 24
Number of successful viral culturing attempts (SARS-CoV-2)
Viral culturing - Day 30
Time frame: Day 30
Number of successful viral culturing attempts (SARS-CoV-2)
8 secondary outcomes
Baseline Viral Load - Day 0
Time frame: Day 0
Change from Baseline Viral Load - Day 3
Time frame: Day 3
Change from Baseline Viral Load - Day 7
Time frame: Day 7
Change from Baseline Viral Load - Day 10
Time frame: Day 10
Change from Baseline Viral Load - Day 14
Time frame: Day 14
Change from Baseline Viral Load - Day 17
Time frame: Day 17
Change from Baseline Viral Load - Day 24
Time frame: Day 24
Change from Baseline Viral Load - Day 30
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Derived from this study: PubMed 36698135Sejdic A, Frische A, Jorgensen CS, Rasmussen LD, Trebbien R, Dungu A, Holler JG, Ostrowski SR, Eriksson R, Soborg C, Nielsen TL, Fischer TK, Lindegaard B, Franck KT, Harboe ZB. High titers of neutralizing SARS-CoV-2 antibodies six months after symptom onset are associated with increased severity in COVID-19 hospitalized patients. Virol J. 2023 Jan 25;20(1):14. doi: 10.1186/s12985-023-01974-8.
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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.
Zitta Barrella Harboe, MD, PhD principal investigator
Nordsjaellands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia and COVID-19, run by Nordsjaellands Hospital at 1 site in Denmark.
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 3 inclusion and 2 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 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutralizing Antibody Titer - Day 0 (time frame: Day 0). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05274373, which also lists 1 linked publication.
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 10 Mar 2022.