Covid19OPTIMISTNCT04871789
Optimization of Patients Long-term Management After the Coronavirus Infection COVID-19
An observational study of Covid19, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
200 participants should be included in the study. There will be three groups: 100 participants with a severe course of the disease 3 months ago, 50 asymptomatic carriers of coronavirus infection 3 months ago and 50 people who were in close contact with patients with confirmed coronavirus infection 3 months ago, but… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Laboratory and instrumental examination
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 20 Jan 2021to 15 Jun 2021
- 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: Men and women aged 18 and over with asymptomatic or severe course of the novel coronavirus infection COVID-19, or who have been in close contact with patients with confirmed coronavirus infection, but who are not sick and do not have antibodies to SARS-CoV-2
Who may be able to join
- For all groups:
- Informed consent signed by the patient.
- Men and women aged 18 and over.
- Group COVID-19 (asymptomatic):
- Confirmed diagnosis of COVID-19 (positive SARS-CoV-2 RNA PCR test or history of IgM and / or IgG antibodies to SARS-CoV-2)
- Absence of any clinical symptoms associated with coronavirus infection.
Show all 19Show fewer
- Group Healthy:
- Contact with patients with symptomatic new coronavirus infection COVID-19 in the absence of personal protective equipment for at least 3 days.
- Absence of any clinical symptoms associated with coronavirus infection
- Group COVID symptomatic:
- Confirmed diagnosis of previous COVID-19 (positive SARS-CoV-2 RNA PCR test or presence of IgM antibodies to SARS-CoV-2) in history.
- A severe course of COVID-19, characterized by one or more of the following symptoms:
- Respiratory rate ≥ 30 in 1 min
- Blood oxygen saturation (SpO2) ≤ 93%
- The ratio of the partial tension of oxygen in arterial blood to the fraction of oxygen during inspiration (PaO2 / FiO2) <300
- Lung tissue lesion> 50% and / or according to computed tomography CT-2 and higher
- Septic shock / sepsis
- Development of multiple organ failure
- Cytokine storm
Who cannot join
- Pregnancy
- Covid-19 vaccination
- Any serious medical illness before coronavirus infection, as well as a permanent form of atrial fibrillation
- Regular intake of anti-inflammatory, antibacterial, cytostatic and immunosuppressive drugs
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Daria Kashtanova, MD, PhD contact
Olga Tkacheva, MD, PhD contact
Russia1 site, 1 recruiting
- Recruiting
Russian Clinical Research Center for Gerontology
Moscow, 129226
Olga Tkacheva, MD, PhD, rgnkc@rgnkc.ru
About this study
200 participants should be included in the study. There will be three groups: 100 participants with a severe course of the disease 3 months ago, 50 asymptomatic carriers of coronavirus infection 3 months ago and 50 people who were in close contact with patients with confirmed coronavirus infection 3 months ago, but not sick and without antibodies to SARS-CoV-2.
The study consists of two visits. At the first visit, after signing the consent to participate in the study, a screening examination will be performed to assess the criteria for inclusion and exclusion in the study.
Read more
At the second visit, patients who meet the inclusion criteria and do not have exclusion criteria will undergo clinical and instrumental examination, and biological samples will be collected for laboratory testing.
The aim of the study is to determine the most significant clinical and laboratory markers of the severity of the outcomes in the period of convalescence of the new coronavirus infection COVID-19. Clinical and laboratory indicators, the number and severity of signs of postcovid syndrome as well as pathological changes in lung tissue according to CT data in the group with covid pneumonia and indicators of immune status, hemostasis, endothelial dysfunction, inflammation, metabolism will be assessed.
- Conditions
- Covid19
- Being tested
- Laboratory and instrumental examination
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory and instrumental examinationDiagnostic test
All patients will undergo a comprehensive examination to identify the consequences of COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe COVID-19 pneumonia | Not described Receives: Diagnostic Test: Laboratory and instrumental examination | |
| Patients who had an asymptomatic COVID-19 3 months ago | Not described Receives: Diagnostic Test: Laboratory and instrumental examination | |
| People who had close contact with patients with confirmed COVID-19 3 months ago but did not get sick | Not described Receives: Diagnostic Test: Laboratory and instrumental examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presense of postcovid syndrome
Clinical and laboratory indicators The number and severity of signs of postcovid syndrome
Measured: through study completion, an average of 3 months
Secondary outcomes (1)
Pathological changes in lung tissue according to CT data
CT scan
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start20 Jan 2021
- Primary completion15 May 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871789
- Sponsor's protocol ID
- COVID_2020_01
- Acronym
- OPTIMIST
- Status last verified
- Mar 2021
- First submitted
- 21 Mar 2021
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Patients Long-term Management After the Coronavirus Infection COVID-19
- ClinicalTrials.gov ID
- NCT04871789
- Acronym / sponsor ID
- OPTIMIST / COVID_2020_01
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 15 May 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 4 May 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.
200 participants should be included in the study. There will be three groups: 100 participants with a severe course of the disease 3 months ago, 50 asymptomatic carriers of coronavirus infection 3 months ago and 50 people who were in close contact with patients with confirmed coronavirus infection 3 months ago, but not sick and without antibodies to SARS-CoV-2.
The study consists of two visits. At the first visit, after signing the consent to participate in the study, a screening examination will be performed to assess the criteria for inclusion and exclusion in the study.
At the second visit, patients who meet the inclusion criteria and do not have exclusion criteria will undergo clinical and instrumental examination, and biological samples will be collected for laboratory testing.
The aim of the study is to determine the most significant clinical and laboratory markers of the severity of the outcomes in the period of convalescence of the new coronavirus infection COVID-19. Clinical and laboratory indicators, the number and severity of signs of postcovid syndrome as well as pathological changes in lung tissue according to CT data in the group with covid pneumonia and indicators of immune status, hemostasis, endothelial dysfunction, inflammation, metabolism will be assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with severe COVID-19 pneumonia | – | Diagnostic Test: Laboratory and instrumental examination |
| Patients who had an asymptomatic COVID-19 3 months ago | – | Diagnostic Test: Laboratory and instrumental examination |
| People who had close contact with patients with confirmed COVID-19 3 months ago but did not get sick | – | Diagnostic Test: Laboratory and instrumental examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women aged 18 and over with asymptomatic or severe course of the novel coronavirus infection COVID-19, or who have been in close contact with patients with confirmed coronavirus infection, but who are not sick and do not have antibodies to SARS-CoV-2
Key inclusion criteria (19 listed)
- Informed consent signed by the patient.
- Men and women aged 18 and over.
- Confirmed diagnosis of COVID-19 (positive SARS-CoV-2 RNA PCR test or history of IgM and / or IgG antibodies to SARS-CoV-2)
- Absence of any clinical symptoms associated with coronavirus infection.
- Contact with patients with symptomatic new coronavirus infection COVID-19 in the absence of personal protective equipment for at least 3 days.
Key exclusion criteria (5 listed)
- Pregnancy
- Covid-19 vaccination
- Any serious medical illness before coronavirus infection, as well as a permanent form of atrial fibrillation
- Regular intake of anti-inflammatory, antibacterial, cytostatic and immunosuppressive drugs
- Refusal to participate in the study
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 |
|---|---|---|
| Laboratory and instrumental examinationAll patients will undergo a comprehensive examination to identify the consequences of COVID-19 | Diagnostic test | Patients who had an asymptomatic COVID-19 3 months ago, Patients with severe COVID-19 pneumonia, People who had close contact with patients with confirmed COVID-19 3 months ago but did not get sick |
Primary outcome
The presense of postcovid syndrome
Time frame: through study completion, an average of 3 months
Clinical and laboratory indicators The number and severity of signs of postcovid syndrome
1 secondary outcome
Pathological changes in lung tissue according to CT data
Time frame: through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- 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.
Daria Kashtanova, MD, PhD contact
Olga Tkacheva, MD, PhD contact
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 Covid19, run by Pirogov Russian National Research Medical University 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 19 inclusion and 5 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 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daria Kashtanova, MD, PhD (dr.kashtanova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presense of postcovid syndrome (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2021.