Covid19NCT04752085
Prognosis and Course of COVID-19 Infection in Hospitalised Patients
An observational study of Covid19 and SARS-CoV Infection, run by I.M. Sechenov First Moscow State Medical University at 2 sites in Russia.
Trial summary
The aim of the cohort prospective observational study is to define the major factors influencing the course of COVID-19 infections and its prognosis in hospitalised patients. The investigators plan to include 300 patients hospitalised with COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, SARS-CoV Infection
- What is being tested?
- Chitotriosidase activity
- How many people
- 345 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Nov 2020to 10 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 300 patients hospitalised with COVID-19 infection
Who may be able to join
- Hospitalisation with COVID-19
Who cannot join
- History of hospitalisation with COVID-19 infection
- Discharge from the hospital before the end of the treatment course
- Transfer to another hospital
Trial locations and contacts
2 sites in 1 country.
About this study
The aim of the cohort prospective observational study is to define the major factors influencing the course of COVID-19 infections and its prognosis in hospitalised patients.
The investigators plan to include 300 patients hospitalised with COVID-19 infection.
The phone contacts with patients are due after 90 and 180 days after discharge.
- Conditions
- Covid19, SARS-CoV Infection
- Being tested
- Chitotriosidase activity
- Keywords
- COVID-19, chitotriosidase, SARS-CoV Infection
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chitotriosidase activityDiagnostic test
The chitotriosidase activity will be measured in all the subjects
What is being measured
The primary outcome is the main question the study is designed to answer.
Need in biological therapy or/and respiratory support
The primary endpoint is the need in biological therapy or/and respiratory support including noninvasive ventilation during hospital stay
Measured: Up to 1 month
Secondary outcomes (3)
Number of days spent in hospital
The investigators plan to assess the overall length of hospitalisation due to COVID-19 infection as an outcome measure
Measured: Up to 1 month
All-cause death
To assess the all-cause death 90 days after discharge
Measured: 90 days
All-cause death
To assess the all-cause death 180 days after discharge
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Nov 2020
- Primary completion1 Mar 2021
- Study completion10 Jan 2023
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 Covid19Studies 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
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Mironova, I.M. Sechenov First Moscow State Medical University
- Investigators
- Olga Mironova, PhD, Principal investigator, Sechenov UniversityEkaterina Schelkanovtseva, MD, Study chair, Sechenov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752085
- Sponsor's protocol ID
- 03-21
- Status last verified
- Jan 2023
- First submitted
- 9 Feb 2021
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schelkanovtseva ES, Isaev GO, Mironova OY, Balakhonov AA, Skvortsov AV, Nagornov IO, Suvorov AY, Fomin VV, Panferov AS. [The survival prediction of hospitalized patients with COVID-19: the role of chitotriosidase level in peripheral blood]. Ter Arkh. 2023 Sep 29;95(7):543-547. doi: 10.26442/00403660.2023.07.202280. Russian.
PubMed 38159003
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis and Course of COVID-19 Infection in Hospitalised Patients
- ClinicalTrials.gov ID
- NCT04752085
- Acronym / sponsor ID
- 03-21
- Conditions
- Covid19, SARS-CoV Infection
- Keywords
- COVID-19, chitotriosidase, SARS-CoV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 12 Feb 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.
The aim of the cohort prospective observational study is to define the major factors influencing the course of COVID-19 infections and its prognosis in hospitalised patients.
The investigators plan to include 300 patients hospitalised with COVID-19 infection.
The phone contacts with patients are due after 90 and 180 days after discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 patients hospitalised with COVID-19 infection
Key inclusion criteria (1 listed)
- Hospitalisation with COVID-19
Key exclusion criteria (3 listed)
- History of hospitalisation with COVID-19 infection
- Discharge from the hospital before the end of the treatment course
- Transfer to another hospital
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 |
|---|---|---|
| Chitotriosidase activityThe chitotriosidase activity will be measured in all the subjects | Diagnostic test | – |
Primary outcome
Need in biological therapy or/and respiratory support
Time frame: Up to 1 month
The primary endpoint is the need in biological therapy or/and respiratory support including noninvasive ventilation during hospital stay
3 secondary outcomes
Number of days spent in hospital
Time frame: Up to 1 month
All-cause death
Time frame: 90 days
All-cause death
Time frame: 180 days
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 26 Jan 2023.
- Derived from this study: PubMed 38159003Schelkanovtseva ES, Isaev GO, Mironova OY, Balakhonov AA, Skvortsov AV, Nagornov IO, Suvorov AY, Fomin VV, Panferov AS. [The survival prediction of hospitalized patients with COVID-19: the role of chitotriosidase level in peripheral blood]. Ter Arkh. 2023 Sep 29;95(7):543-547. doi: 10.26442/00403660.2023.07.202280. Russian.
- 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.
Olga Mironova, PhD principal investigator
Sechenov University
Ekaterina Schelkanovtseva, MD study chair
Sechenov University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and SARS-CoV Infection, run by I.M. Sechenov First Moscow State Medical University at 2 sites 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 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Need in biological therapy or/and respiratory support (time frame: Up to 1 month). 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 NCT04752085, 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 26 Jan 2023.