SARS-CoV2NCT04450017
Clinical Features of Severe Patients With COVID-19
An observational study of SARS-CoV2, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.
Trial summary
As coronavirus disease 2019 (COVID-19) spreads across the world, the intensive care unit (ICU) community must prepare for the challenges associated with this pandemic. Providing an efficient care to the patients of the most severely affected category - intensive care unit (ICU) patients - has become one of the serious… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- SARS-CoV2
- What is being tested?
- The demographic, clinical, laboratory, and instrumental data
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 6 Apr 2020to 30 Jun 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with COVID-19 requiring respiratory support
Who may be able to join
- all patients with COVID-19 admitted to the ICU with invasive and noninvasive ventilation
Who cannot join
- less than 24 hours in ICU by any reason,
- chronic decompensated diseases with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure),
- atonic coma.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal Research Clinical Center of Federal Medical & Biological Agency
Moscow, 115682
About this study
As coronavirus disease 2019 (COVID-19) spreads across the world, the intensive care unit (ICU) community must prepare for the challenges associated with this pandemic. Providing an efficient care to the patients of the most severely affected category - intensive care unit (ICU) patients - has become one of the serious problems appearing in the COVID-19 pandemics. A typical patient's clinical portrait in ICU of COVID centers is very similar in different countries, however, the key to improve the treatment results for critically ill patients has not yet been found. Data on predictors of severe course in COVID-19 is limited. Knowledge of predictors of severe course of disease can lead to different selection of therapeutic strategy, determine the group of risk of patients for severe course of disease, and improve outcomes.
Read the detailed description
The clinical disease (COVID-19) results in critical illness in about 5% of patients. The aim of the study is to identify predictors of the severe pneumonia caused by the SARS-CoV-2 virus, and to describe the clinical features of patients admitted to an ICU of the COVID-center of the Federal Research Clinical Center of Federal Medical \& Biological Agency on the first day and in dynamics till discharge from the ICU or death.
The demographic and clinical data will be collected. Laboratory data (hemoglobin, lymphocytes, neutrophil to lymphocyte ratio, D-dimer level, IL-6, procalcitonin, glucose level, high-sensitive troponin Т, vitamin D level, signs of the presence of a secondary bacterial infection, immunogram and Instrumental data (CT-scan, Electrocardiography, echocardiography, arterial and venous ultrasound investigation) will be analysed.
This study is singlecentral observational trial.
- Conditions
- SARS-CoV2
- Being tested
- The demographic, clinical, laboratory, and instrumental data
- Keywords
- SARS pneumonia, COVID-19, severe disease, risk factors
- Medical subject headings
- COVID-19, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The demographic, clinical, laboratory, and instrumental dataDiagnostic test
Measurement of the demographic, clinical data, laboratory data, and instrumental data
| Study group | Role | What they receive |
|---|---|---|
| Clinical Features of Severe Patients With COVID-19 | Critical ill patients with COVID-19 admitted to the ICU. The demographic, clinical data, laboratory data, and Instrumental data will be analysed. Receives: Diagnostic Test: The demographic, clinical, laboratory, and instrumental data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical ventilation duration
The amount of mechanical ventilation days
Measured: 30 days
Non-invasive Mechanical ventilation duration
The amount of Non-invasive mechanical ventilation days
Measured: 30 days
Mortality
The dead and survived patients ratio
Measured: 60 days
Secondary outcomes (11)
Сomplete blood count
Сomplete blood count
Measured: Change from baseline on day 5 during ICU treatment
Biochemistry analysis
Biochemistry analysis
Measured: Change from baseline on day 5 during ICU treatment
Сomplete blood count dynamics
Сomplete blood count
Measured: Change from baseline on day 15 during ICU treatment
Biochemistry analysis dynamics
Biochemistry analysis
Measured: Change from baseline on day 15 during ICU treatment
Computer tomography
Computer tomography of lungs
Measured: Change from baseline on day 5 during ICU treatment
High-sensitive troponin Т
High-sensitive troponin Т
Measured: Change from baseline on day 5 during ICU treatment
High-sensitive troponin Т dynamics
High-sensitive troponin Т
Measured: Change from baseline on day 15 during ICU treatment
Vitamin D level
Vitamin D level
Measured: Change from baseline on day 5 during ICU treatment
Vitamin D level dynamics
Vitamin D level
Measured: Change from baseline on day 15 during ICU treatment
Immunogram
Immunogram
Measured: Change from baseline on day 5 during ICU treatment
Immunogram dynamics
Immunogram
Measured: Change from baseline on day 15 during ICU treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start6 Apr 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 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 SARS-CoV2Studies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tatiana V Klypa, Dr.Med.Sc., Principal investigator, Federal Research Clinical Center of Federal Medical & Biological Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450017
- Sponsor's protocol ID
- COVID-ICU
- Status last verified
- May 2021
- First submitted
- 23 Jun 2020
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143Tian W, Jiang W, Yao J, Nicholson CJ, Li RH, Sigurslid HH, Wooster L, Rotter JI, Guo X, Malhotra R. Predictors of mortality in hospitalized COVID-19 patients: A systematic review and meta-analysis. J Med Virol. 2020 Oct;92(10):1875-1883. doi: 10.1002/jmv.26050. Epub 2020 Jul 11.
PubMed 32441789Paranjpe I, Russak AJ, De Freitas JK, Lala A, Miotto R, Vaid A, Johnson KW, Danieletto M, Golden E, Meyer D, Singh M, Somani S, Manna S, Nangia U, Kapoor A, O'Hagan R, O'Reilly PF, Huckins LM, Glowe P, Kia A, Timsina P, Freeman RM, Levin MA, Jhang J, Firpo A, Kovatch P, Finkelstein J, Aberg JA, Bagiella E, Horowitz CR, Murphy B, Fayad ZA, Narula J, Nestler EJ, Fuster V, Cordon-Cardo C, Charney DS, Reich DL, Just AC, Bottinger EP, Charney AW, Glicksberg BS, Nadkarni GN. Clinical Characteristics of Hospitalized Covid-19 Patients in New York City. medRxiv [Preprint]. 2020 Apr 26:2020.04.19.20062117. doi: 10.1101/2020.04.19.20062117.
PubMed 32511655Bychinin MV, Klypa TV, Mandel IA, Andreichenko SA, Baklaushev VP, Yusubalieva GM, Kolyshkina NA, Troitsky AV. Low Circulating Vitamin D in Intensive Care Unit-Admitted COVID-19 Patients as a Predictor of Negative Outcomes. J Nutr. 2021 Aug 7;151(8):2199-2205. doi: 10.1093/jn/nxab107.
PubMed 33982128
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features of Severe Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04450017
- Acronym / sponsor ID
- COVID-ICU
- Conditions
- SARS-CoV2
- Keywords
- SARS pneumonia, COVID-19, severe disease, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, RussiaOther government
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 29 Jun 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.
As coronavirus disease 2019 (COVID-19) spreads across the world, the intensive care unit (ICU) community must prepare for the challenges associated with this pandemic. Providing an efficient care to the patients of the most severely affected category - intensive care unit (ICU) patients - has become one of the serious problems appearing in the COVID-19 pandemics. A typical patient's clinical portrait in ICU of COVID centers is very similar in different countries, however, the key to improve the treatment results for critically ill patients has not yet been found. Data on predictors of severe course in COVID-19 is limited. Knowledge of predictors of severe course of disease can lead to different selection of therapeutic strategy, determine the group of risk of patients for severe course of disease, and improve outcomes.
Detailed description
The clinical disease (COVID-19) results in critical illness in about 5% of patients. The aim of the study is to identify predictors of the severe pneumonia caused by the SARS-CoV-2 virus, and to describe the clinical features of patients admitted to an ICU of the COVID-center of the Federal Research Clinical Center of Federal Medical \& Biological Agency on the first day and in dynamics till discharge from the ICU or death.
The demographic and clinical data will be collected. Laboratory data (hemoglobin, lymphocytes, neutrophil to lymphocyte ratio, D-dimer level, IL-6, procalcitonin, glucose level, high-sensitive troponin Т, vitamin D level, signs of the presence of a secondary bacterial infection, immunogram and Instrumental data (CT-scan, Electrocardiography, echocardiography, arterial and venous ultrasound investigation) will be analysed.
This study is singlecentral observational trial.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Features of Severe Patients With COVID-19 | – | Diagnostic Test: The demographic, clinical, laboratory, and instrumental dataCritical ill patients with COVID-19 admitted to the ICU. The demographic, clinical data, laboratory data, and Instrumental data will be analysed. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with COVID-19 requiring respiratory support
Key inclusion criteria (1 listed)
- all patients with COVID-19 admitted to the ICU with invasive and noninvasive ventilation
Key exclusion criteria (3 listed)
- less than 24 hours in ICU by any reason,
- chronic decompensated diseases with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure),
- atonic coma.
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 |
|---|---|---|
| The demographic, clinical, laboratory, and instrumental dataMeasurement of the demographic, clinical data, laboratory data, and instrumental data | Diagnostic test | Clinical Features of Severe Patients With COVID-19 |
Primary outcome
Mechanical ventilation duration
Time frame: 30 days
The amount of mechanical ventilation days
Non-invasive Mechanical ventilation duration
Time frame: 30 days
The amount of Non-invasive mechanical ventilation days
Mortality
Time frame: 60 days
The dead and survived patients ratio
11 secondary outcomes
Сomplete blood count
Time frame: Change from baseline on day 5 during ICU treatment
Biochemistry analysis
Time frame: Change from baseline on day 5 during ICU treatment
Сomplete blood count dynamics
Time frame: Change from baseline on day 15 during ICU treatment
Biochemistry analysis dynamics
Time frame: Change from baseline on day 15 during ICU treatment
Computer tomography
Time frame: Change from baseline on day 5 during ICU treatment
High-sensitive troponin Т
Time frame: Change from baseline on day 5 during ICU treatment
High-sensitive troponin Т dynamics
Time frame: Change from baseline on day 15 during ICU treatment
Vitamin D level
Time frame: Change from baseline on day 5 during ICU treatment
Vitamin D level dynamics
Time frame: Change from baseline on day 15 during ICU treatment
Immunogram
Time frame: Change from baseline on day 5 during ICU treatment
Immunogram dynamics
Time frame: Change from baseline on day 15 during ICU treatment
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 May 2021.
- Background: PubMed 32007143Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Background: PubMed 32441789Tian W, Jiang W, Yao J, Nicholson CJ, Li RH, Sigurslid HH, Wooster L, Rotter JI, Guo X, Malhotra R. Predictors of mortality in hospitalized COVID-19 patients: A systematic review and meta-analysis. J Med Virol. 2020 Oct;92(10):1875-1883. doi: 10.1002/jmv.26050. Epub 2020 Jul 11.
- Background: PubMed 32511655Paranjpe I, Russak AJ, De Freitas JK, Lala A, Miotto R, Vaid A, Johnson KW, Danieletto M, Golden E, Meyer D, Singh M, Somani S, Manna S, Nangia U, Kapoor A, O'Hagan R, O'Reilly PF, Huckins LM, Glowe P, Kia A, Timsina P, Freeman RM, Levin MA, Jhang J, Firpo A, Kovatch P, Finkelstein J, Aberg JA, Bagiella E, Horowitz CR, Murphy B, Fayad ZA, Narula J, Nestler EJ, Fuster V, Cordon-Cardo C, Charney DS, Reich DL, Just AC, Bottinger EP, Charney AW, Glicksberg BS, Nadkarni GN. Clinical Characteristics of Hospitalized Covid-19 Patients in New York City. medRxiv [Preprint]. 2020 Apr 26:2020.04.19.20062117. doi: 10.1101/2020.04.19.20062117.
- Derived from this study: PubMed 33982128Bychinin MV, Klypa TV, Mandel IA, Andreichenko SA, Baklaushev VP, Yusubalieva GM, Kolyshkina NA, Troitsky AV. Low Circulating Vitamin D in Intensive Care Unit-Admitted COVID-19 Patients as a Predictor of Negative Outcomes. J Nutr. 2021 Aug 7;151(8):2199-2205. doi: 10.1093/jn/nxab107.
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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.
Tatiana V Klypa, Dr.Med.Sc. principal investigator
Federal Research Clinical Center of Federal Medical & Biological Agency
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 SARS-CoV2, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.
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 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 May 2021. 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 Russia. 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?
Mechanical ventilation duration (time frame: 30 days). 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?
On the ClinicalTrials.gov record for NCT04450017, 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 May 2021.