COVID-19CARECOVIDNCT05172180
Correction of Metabolic Disorders and Its Effect on Respiratory Function of Lungs in Patients With Severe COVID-19
An observational study of COVID-19, run by POLYSAN Scientific & Technological Pharmaceutical Company at 1 site in Russia.
Trial summary
Objective of the study: to investigate the effect of meglumine succinate solution on the dynamics of metabolic blood parameters and respiratory function of the lungs in intensive care patients with new coronavirus infection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Reamberin and Ringer's solution
- Type of treatment
- Injection or infusion
- How many people
- 105 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 2020to 1 Apr 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe novel coronavirus infection COVID-19 (NCI) who were treated at the intensive care unit (ICU)
Who may be able to join
- age 18-70 years;
- diagnosis of SARS-COV-2 NCI confirmed by laboratory tests;
- the lung lesion volume on CT scan is significant or subtotal - CT 3-4;
- initiation of infusion therapy on the 1st day after patient admission to ICU
Who cannot join
- 1) presence of initial indications for transfer to invasive ALV at the time of screening; 2) history of Reamberin intolerance; 3) administration of other polyelectrolyte solutions with reserve alkalinity carriers; 4) pregnancy and postpartum; 5) severe renal failure requiring renal replacement therapy; 6) severe hepatic failure (Child-Pugh class C or higher); 7) diabetes mellitus; 8) terminal stage of other chronic incurable diseases
Trial locations and contacts
1 site in 1 country.
Russia1 site
Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko
Nizhny Novgorod
About this study
Objective of the study: to investigate the effect of meglumine succinate solution on the dynamics of metabolic blood parameters and respiratory function of the lungs in intensive care patients with new coronavirus infection. An observational prospective study included 105 patients with a severe course of novel coronavirus infection
- Conditions
- COVID-19
- Being tested
- Reamberin, Ringer's solution
- Keywords
- COVID-19, METABOLIC DISORDERS, Respiratory function of the lungs
- Medical subject headings
- COVID-19, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReamberinDrug
the balanced succinate-containing crystalloid solution Reamberin (meglumine sodium succinate)
Ringer's solutionDrug
Ringer's solution at an average daily dose of 8.1 ml/kg/day
| Study group | Role | What they receive |
|---|---|---|
| The control group | The control group consisted of 54 patients who received Ringer's solution at an average daily dose of 8.1 ml/kg/day as the main infusion solution from the time of transfer to the intensive care unit Receives: Drug: Ringer's solution | |
| The test group | Fifty one patients in the test group received the balanced succinate-containing crystalloid solution Reamberin (meglumine sodium succinate) at an average daily dose of 8.3 ml/kg/day for the same purpose Receives: Drug: Reamberin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality, %
Proportion of patients died during the period of hospital stay
Measured: from date of treatment start until the date of death or the date of discharge from hospital
Duration of treatment at ICU, days
Duration of treatment at ICU
Measured: from date of treatment start until the date of death or the date of discharge from hospital
Duration of treatment after ICU, days
Duration of treatment after ICU
Measured: from date of treatment start until the date of death or the date of discharge from hospital
Secondary outcomes (6)
Glucose
Venous blood Glucose
Measured: baseline, day 2, day 3, day 5, day 11
Lactate
Venous blood Lactate
Measured: baseline, day 2, day 3, day 5, day 11
pH
Blood gases
Measured: baseline, day 2, day 3, day 5, day 11
BE
Blood gases
Measured: baseline, day 2, day 3, day 5, day 11
Dynamics of right diaphragm excursion, cm
Diaphragm mobility
Measured: baseline, day 2, day 3, day 5, day 11
Total duration of inpatient treatment, days
Total duration of inpatient treatment
Measured: from date of treatment start until the date of death or the date of discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Dec 2020
- Primary completion31 Jan 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172180
- Sponsor's protocol ID
- CARECOVID
- Acronym
- CARECOVID
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2021
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Metabolic Disorders and Its Effect on Respiratory Function of Lungs in Patients With Severe COVID-19
- ClinicalTrials.gov ID
- NCT05172180
- Acronym / sponsor ID
- CARECOVID / CARECOVID
- Conditions
- COVID-19
- Keywords
- COVID-19, METABOLIC DISORDERS, Respiratory function of the lungs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 29 Dec 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.
Objective of the study: to investigate the effect of meglumine succinate solution on the dynamics of metabolic blood parameters and respiratory function of the lungs in intensive care patients with new coronavirus infection. An observational prospective study included 105 patients with a severe course of novel coronavirus infection
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | – | Drug: Ringer's solutionThe control group consisted of 54 patients who received Ringer's solution at an average daily dose of 8.1 ml/kg/day as the main infusion solution from the time of transfer to the intensive care unit |
| The test group | – | Drug: ReamberinFifty one patients in the test group received the balanced succinate-containing crystalloid solution Reamberin (meglumine sodium succinate) at an average daily dose of 8.3 ml/kg/day for the same purpose |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe novel coronavirus infection COVID-19 (NCI) who were treated at the intensive care unit (ICU)
Key inclusion criteria (4 listed)
- age 18-70 years;
- diagnosis of SARS-COV-2 NCI confirmed by laboratory tests;
- the lung lesion volume on CT scan is significant or subtotal - CT 3-4;
- initiation of infusion therapy on the 1st day after patient admission to ICU
Key exclusion criteria (1 listed)
- 1) presence of initial indications for transfer to invasive ALV at the time of screening; 2) history of Reamberin intolerance; 3) administration of other polyelectrolyte solutions with reserve alkalinity carriers; 4) pregnancy and postpartum; 5) severe renal failure requiring renal replacement therapy; 6) severe hepatic failure (Child-Pugh class C or higher); 7) diabetes mellitus; 8) terminal stage of other chronic incurable diseases
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 |
|---|---|---|
| Reamberinthe balanced succinate-containing crystalloid solution Reamberin (meglumine sodium succinate) | Drug | The test group |
| Ringer's solutionRinger's solution at an average daily dose of 8.1 ml/kg/day | Drug | The control group |
Primary outcome
Mortality, %
Time frame: from date of treatment start until the date of death or the date of discharge from hospital
Proportion of patients died during the period of hospital stay
Duration of treatment at ICU, days
Time frame: from date of treatment start until the date of death or the date of discharge from hospital
Duration of treatment at ICU
Duration of treatment after ICU, days
Time frame: from date of treatment start until the date of death or the date of discharge from hospital
Duration of treatment after ICU
6 secondary outcomes
Glucose
Time frame: baseline, day 2, day 3, day 5, day 11
Lactate
Time frame: baseline, day 2, day 3, day 5, day 11
pH
Time frame: baseline, day 2, day 3, day 5, day 11
BE
Time frame: baseline, day 2, day 3, day 5, day 11
Dynamics of right diaphragm excursion, cm
Time frame: baseline, day 2, day 3, day 5, day 11
Total duration of inpatient treatment, days
Time frame: from date of treatment start until the date of death or the date of discharge from hospital
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 19 Dec 2024.
- Metabolic therapy and its impact on lung respiratory function in patients with severe COVID-19 A.Yu. Yakovlev, A.A. Pevnev, M.V. Dudorova, Yu.V. Ilyin, M.S. Belous https://doi.org/10.17816/KMJ2022-364Link provided by the sponsor.
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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-19, run by POLYSAN Scientific & Technological Pharmaceutical Company 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 4 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: finished, as of the sponsor's last update on 19 Dec 2024. 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?
Mortality, % (time frame: from date of treatment start until the date of death or the date of discharge from hospital). 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?
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 19 Dec 2024.