COVIDCRITICoVidNCT04407169
Prevalence of Critical Forms of CoVid-19 in Patients With Chronic Respiratory Disease
An observational study of COVID, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
A new Coronavirus (SARS-CoV-2) emerged in Wuhan Province, China in December 2019 and rapidly spread around the world. To date, the data in the literature regarding the clinical and epidemiological characteristics of severe forms of CoVid-19 in patients with chronic respiratory disease are not well known. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID
- How many people
- 617 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 17 Nov 2020
- 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: All patients hospitalized for severe CoVid-19 with or without chronic respiratory disease
Who may be able to join
- Age greater than or equal to 18 years of age
- Diagnosis of CoVid-2 SARS infection retained (from clinical presentation, radiological and CoVid-19 positive microbiological specimen).
- Hospitalisation in the conventional medical sector for "respiratory" reasons (= severe form of CoVid-19) in the Nancy-Brabois hospital and Metz-Thionville Hospital between 02/03/2020 and 15/06/2020.
Who cannot join
- Diagnosis of SARS-CoV-2 infection not retained
- Refusal of the patient to participate in the study
- Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code: o Pregnant woman, parturient or breastfeeding mother o Minors (not emancipated) o Persons of full age subject to a legal protection measure (guardianship, curatorship, safeguard of justice) - Persons of full age unable to express their consent Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care by virtue of articles L. 3212-1 and L. 3213-1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prevalence of Critical Forms of CoVid-19 in Patients With Chronic Respiratory Disease Hospitalized for Severe Forms
A new Coronavirus (SARS-CoV-2) emerged in Wuhan Province, China in December 2019 and rapidly spread around the world. To date, the data in the literature regarding the clinical and epidemiological characteristics of severe forms of CoVid-19 in patients with chronic respiratory disease are not well known.
The hypothesis is that patients with chronic respiratory disease (COPD, asthma, bronchial dilatations, pulmonary hypertension, cystic fibrosis, obesity-hypoventilation syndrome, obstructive sleep apnea syndrome) infected with SARS-Cov-2 will have increased dyspnea and hypoxemia leading to hospitalization for severe forms more frequently than the general population. However, they do not appear to be more at risk of developing a critical form.
This study is carried out in order to propose to estimate the prevalence of critical forms of CoVid19 among patients with chronic respiratory diseases hospitalized for severe forms.
- Conditions
- COVID
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
There will be no intervention. It is only an observationnal study
| Study group | Role | What they receive |
|---|---|---|
| Patients without chronic respiratory disease | All patients hospitalized for severe CoVid-19 without chronic respiratory disease Receives: Other: no intervention | |
| Patients with chronic respiratory diseas | Patients hospitalized for severe CoVid-19 with one chronic respiratory disease Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who reached, during their hospitalization, a value greater than or equal to 6 on the WHO CoVid-19 infection progression scale
Value of 6 or greeter on WHO CoVid-19 scale, indicating of a critical form of CoVid-19.
Measured: up to 28 days (during hospitalisation)
Secondary outcomes (5)
Determined potential predictive factors of critic form in patients with chronic lung diseases
Radiological damage (extension of ground-glass) could be a predictive factor.
Measured: up to 28 days (during hospitalisation)
Determined percentage of death
intra-hospital death, intra-ICU death
Measured: up to 28 days (during hospitalisation)
Determined duration of oxygen therapy
in days (or duration at a different flow rate compared to long-term home oxygen therapy prior to hospitalization)
Measured: up to 28 days (during hospitalisation)
Determined duration of hospitalization
in days for patients with chronic respiratory disease between the date of admission and the date of discharge. Patients who died during hospitalization will be assigned the highest cohort value.
Measured: up to 28 days (during hospitalisation)
Determine mean values of the WHO CoVid-19 infection progression scale measured
values will be measured at D3, D7 and D14 in each of the groups. Patients who do not reach D7 and D14 will have the last postponement
Measured: up to 28 days (during hospitalisation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Jun 2020
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 617 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407169
- Sponsor's protocol ID
- 2020PI081
- Acronym
- CRITICoVid
- Status last verified
- May 2020
- First submitted
- 14 Apr 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Fang L, Gao P, Bao H, Tang X, Wang B, Feng Y, Cong S, Juan J, Fan J, Lu K, Wang N, Hu Y, Wang L. Chronic obstructive pulmonary disease in China: a nationwide prevalence study. Lancet Respir Med. 2018 Jun;6(6):421-430. doi: 10.1016/S2213-2600(18)30103-6. Epub 2018 Apr 9.
PubMed 29650407Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076Zhang JJ, Dong X, Cao YY, Yuan YD, Yang YB, Yan YQ, Akdis CA, Gao YD. Clinical characteristics of 140 patients infected with SARS-CoV-2 in Wuhan, China. Allergy. 2020 Jul;75(7):1730-1741. doi: 10.1111/all.14238. Epub 2020 Feb 27.
PubMed 32077115
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of Critical Forms of CoVid-19 in Patients With Chronic Respiratory Disease Hospitalized for Severe Forms
- ClinicalTrials.gov ID
- NCT04407169
- Acronym / sponsor ID
- CRITICoVid / 2020PI081
- Conditions
- COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 617 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 29 May 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.
A new Coronavirus (SARS-CoV-2) emerged in Wuhan Province, China in December 2019 and rapidly spread around the world. To date, the data in the literature regarding the clinical and epidemiological characteristics of severe forms of CoVid-19 in patients with chronic respiratory disease are not well known.
The hypothesis is that patients with chronic respiratory disease (COPD, asthma, bronchial dilatations, pulmonary hypertension, cystic fibrosis, obesity-hypoventilation syndrome, obstructive sleep apnea syndrome) infected with SARS-Cov-2 will have increased dyspnea and hypoxemia leading to hospitalization for severe forms more frequently than the general population. However, they do not appear to be more at risk of developing a critical form.
This study is carried out in order to propose to estimate the prevalence of critical forms of CoVid19 among patients with chronic respiratory diseases hospitalized for severe forms.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without chronic respiratory disease | – | Other: no interventionAll patients hospitalized for severe CoVid-19 without chronic respiratory disease |
| Patients with chronic respiratory diseas | – | Other: no interventionPatients hospitalized for severe CoVid-19 with one chronic respiratory disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients hospitalized for severe CoVid-19 with or without chronic respiratory disease
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 years of age
- Diagnosis of CoVid-2 SARS infection retained (from clinical presentation, radiological and CoVid-19 positive microbiological specimen).
- Hospitalisation in the conventional medical sector for "respiratory" reasons (= severe form of CoVid-19) in the Nancy-Brabois hospital and Metz-Thionville Hospital between 02/03/2020 and 15/06/2020.
Key exclusion criteria (3 listed)
- Diagnosis of SARS-CoV-2 infection not retained
- Refusal of the patient to participate in the study
- Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code: o Pregnant woman, parturient or breastfeeding mother o Minors (not emancipated) o Persons of full age subject to a legal protection measure (guardianship, curatorship, safeguard of justice) - Persons of full age unable to express their consent Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care by virtue of articles L. 3212-1 and L. 3213-1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionThere will be no intervention. It is only an observationnal study | Other | Patients with chronic respiratory diseas, Patients without chronic respiratory disease |
Primary outcome
Percentage of patients who reached, during their hospitalization, a value greater than or equal to 6 on the WHO CoVid-19 infection progression scale
Time frame: up to 28 days (during hospitalisation)
Value of 6 or greeter on WHO CoVid-19 scale, indicating of a critical form of CoVid-19.
5 secondary outcomes
Determined potential predictive factors of critic form in patients with chronic lung diseases
Time frame: up to 28 days (during hospitalisation)
Determined percentage of death
Time frame: up to 28 days (during hospitalisation)
Determined duration of oxygen therapy
Time frame: up to 28 days (during hospitalisation)
Determined duration of hospitalization
Time frame: up to 28 days (during hospitalisation)
Determine mean values of the WHO CoVid-19 infection progression scale measured
Time frame: up to 28 days (during hospitalisation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Results publication: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Results publication: PubMed 29650407Fang L, Gao P, Bao H, Tang X, Wang B, Feng Y, Cong S, Juan J, Fan J, Lu K, Wang N, Hu Y, Wang L. Chronic obstructive pulmonary disease in China: a nationwide prevalence study. Lancet Respir Med. 2018 Jun;6(6):421-430. doi: 10.1016/S2213-2600(18)30103-6. Epub 2018 Apr 9.
- Results publication: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
- Results publication: PubMed 32077115Zhang JJ, Dong X, Cao YY, Yuan YD, Yang YB, Yan YQ, Akdis CA, Gao YD. Clinical characteristics of 140 patients infected with SARS-CoV-2 in Wuhan, China. Allergy. 2020 Jul;75(7):1730-1741. doi: 10.1111/all.14238. Epub 2020 Feb 27.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Central Hospital, Nancy, France at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 20 Nov 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients who reached, during their hospitalization, a value greater than or equal to 6 on the WHO CoVid-19 infection progression scale (time frame: up to 28 days (during hospitalisation)). 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 NCT04407169, which also lists 4 linked publications.
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 20 Nov 2020.