Coronavirus Infection (COVID-19)NCT04531202
CORE Study COVID-19
An observational study of Coronavirus Infection (COVID-19), run by D'Or Institute for Research and Education at 1 site in Brazil.
Trial summary
This is a Brazilian version of the Clinical Characterization Protocol for Serious Emerging Infections (ISARIC/WHO ). This is a standardized protocol for the rapid, coordinated clinical investigation of Coronavirus disease (COVID-19). Patients with acute illness suspected to be caused by emerging will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection (COVID-19)
- How many people
- 2,000 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Mar 2020to 30 Sep 2021
- How long will I take part?
- 14 Days
- 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: Patients with coronavirus infection and molecular laboratory diagnosis of COVID-19, made from material collected from the upper respiratory tract (nasopharynx or oropharynx) or from the lower respiratory tract (sputum, tracheal aspirate or bronchoalveolar lavage)
Who may be able to join
- Suspected or proven Coronavirus infection (COVID-19)
Who cannot join
- Confirmed diagnosis of a pathogen unrelated to the objectives of this study (or other non-infectious diagnosis) and no indication or likelihood of co-infection with a relevant pathogen.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
D'Or Institute for Research and Education (IDOR)
Rio de Janeiro, 22281100
Fernando Bozza, phD, 5521993031551, bozza.fernando@gmail.com
About this study
Official title: Clinical Characterization Protocol for Severe Emerging Infections: Coronavirus
This is a Brazilian version of the Clinical Characterization Protocol for Serious Emerging Infections (ISARIC/WHO ). This is a standardized protocol for the rapid, coordinated clinical investigation of Coronavirus disease (COVID-19). Patients with acute illness suspected to be caused by emerging will be enrolled. This protocol has been designed to enable data to be prospectively collected.
Read the detailed description
The study will be conducted at multiple sites (to be determined by the spread of disease and availability of resources). It is appreciated that settings will vary in terms of clinical infrastructure, resources and capacity. This study will enrol eligible patients (adults) with confirmed or suspected infection with a pathogen relevant to the study objectives. Recruitment of patients with Day 1 (enrolment) data and biological samples is the priority.
Observational analyses will be stratified according to available data. Outcome data for primary and secondary objectives will be derived from data from routine clinical and laboratory assessments performed as part of standard inpatient medical management at the treating site, documented using proportionate case report forms (CRF; either paper or web-based electronic 'eCRF'). Clinical and laboratory data will be collected throughout the acute illness period according to local resources. Priority at all times will be given to the collection of clinical information. Research data will be integrated as much as possible with information available from hospital and regulatory files.
- Conditions
- Coronavirus Infection (COVID-19)
- Keywords
- coronavirus
- Medical subject headings
- Coronavirus Infections, COVID-19
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 |
|---|---|---|
| Patients with confirmed or suspected of coronavirus infe | Clinical and laboratory data will be collected throughout the acute illness period. Research data will be integrated with information available from hospital and regulatory files. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characterization of coronavirus disease-2019 (COVID-19)
Describe the clinical features of the illness or syndrome and complications, and determinants of severity.
Assessment daily for 14 days, then hospital discharge.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start2 Mar 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2021 (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 Coronavirus Infection (COVID-19)Studies 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
- 2,000 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Bozza, phD, Principal investigator, D'Or Institute for Research and Education (IDOR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531202
- Sponsor's protocol ID
- 29496920.8.0000.5262
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dunning JW, Merson L, Rohde GGU, Gao Z, Semple MG, Tran D, Gordon A, Olliaro PL, Khoo SH, Bruzzone R, Horby P, Cobb JP, Longuere KS, Kellam P, Nichol A, Brett S, Everett D, Walsh TS, Hien TT, Yu H, Zambon M, Ruiz-Palacios G, Lang T, Akhvlediani T; ISARIC Working Group 3, ISARIC Council; Hayden FG, Marshall J, Webb S, Angus DC, Shindo N, van der Werf S, Openshaw PJM, Farrar J, Carson G, Baillie JK. Open source clinical science for emerging infections. Lancet Infect Dis. 2014 Jan;14(1):8-9. doi: 10.1016/S1473-3099(13)70327-X. No abstract available.
PubMed 24355025
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characterization Protocol for Severe Emerging Infections: Coronavirus
- ClinicalTrials.gov ID
- NCT04531202
- Acronym / sponsor ID
- 29496920.8.0000.5262
- Conditions
- Coronavirus Infection (COVID-19)
- Keywords
- coronavirus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 28 Aug 2020 (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.
This is a Brazilian version of the Clinical Characterization Protocol for Serious Emerging Infections (ISARIC/WHO ). This is a standardized protocol for the rapid, coordinated clinical investigation of Coronavirus disease (COVID-19). Patients with acute illness suspected to be caused by emerging will be enrolled. This protocol has been designed to enable data to be prospectively collected.
Detailed description
The study will be conducted at multiple sites (to be determined by the spread of disease and availability of resources). It is appreciated that settings will vary in terms of clinical infrastructure, resources and capacity. This study will enrol eligible patients (adults) with confirmed or suspected infection with a pathogen relevant to the study objectives. Recruitment of patients with Day 1 (enrolment) data and biological samples is the priority.
Observational analyses will be stratified according to available data. Outcome data for primary and secondary objectives will be derived from data from routine clinical and laboratory assessments performed as part of standard inpatient medical management at the treating site, documented using proportionate case report forms (CRF; either paper or web-based electronic 'eCRF'). Clinical and laboratory data will be collected throughout the acute illness period according to local resources. Priority at all times will be given to the collection of clinical information. Research data will be integrated as much as possible with information available from hospital and regulatory files.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with confirmed or suspected of coronavirus infe | – | –Clinical and laboratory data will be collected throughout the acute illness period. Research data will be integrated with information available from hospital and regulatory files. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronavirus infection and molecular laboratory diagnosis of COVID-19, made from material collected from the upper respiratory tract (nasopharynx or oropharynx) or from the lower respiratory tract (sputum, tracheal aspirate or bronchoalveolar lavage)
Key inclusion criteria (1 listed)
- Suspected or proven Coronavirus infection (COVID-19)
Key exclusion criteria (1 listed)
- Confirmed diagnosis of a pathogen unrelated to the objectives of this study (or other non-infectious diagnosis) and no indication or likelihood of co-infection with a relevant pathogen.
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
Clinical characterization of coronavirus disease-2019 (COVID-19)
Time frame: 1 year
Describe the clinical features of the illness or syndrome and complications, and determinants of severity. Assessment daily for 14 days, then hospital discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Background: PubMed 24355025Dunning JW, Merson L, Rohde GGU, Gao Z, Semple MG, Tran D, Gordon A, Olliaro PL, Khoo SH, Bruzzone R, Horby P, Cobb JP, Longuere KS, Kellam P, Nichol A, Brett S, Everett D, Walsh TS, Hien TT, Yu H, Zambon M, Ruiz-Palacios G, Lang T, Akhvlediani T; ISARIC Working Group 3, ISARIC Council; Hayden FG, Marshall J, Webb S, Angus DC, Shindo N, van der Werf S, Openshaw PJM, Farrar J, Carson G, Baillie JK. Open source clinical science for emerging infections. Lancet Infect Dis. 2014 Jan;14(1):8-9. doi: 10.1016/S1473-3099(13)70327-X. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Fernando Bozza, phD principal investigator
D'Or Institute for Research and Education (IDOR)
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 Coronavirus Infection (COVID-19), run by D'Or Institute for Research and Education at 1 site in Brazil.
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 1 inclusion and 1 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 28 Aug 2020. 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 Brazil. 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?
Contact Fernando Bozza, phD (55 21 993031551, bozza.fernando@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical characterization of coronavirus disease-2019 (COVID-19) (time frame: 1 year). 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 NCT04531202, 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 28 Aug 2020.