Correction of Metabolic Disorders and Its Effect on Respiratory Function of Lungs in Patients With Severe COVID-19 (CARECOVID)

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 Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Ringer's solution; Drug: Reamberin

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Russian Federation
  • Nizhny Novgorod, Russian Federation
    • Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with severe novel coronavirus infection COVID-19 (NCI) who were treated at the intensive care unit (ICU)

Description

Inclusion Criteria:

1. age 18-70 years;
2. diagnosis of SARS-COV-2 NCI confirmed by laboratory tests;
3. the lung lesion volume on CT scan is significant or subtotal - CT 3-4;
4. initiation of infusion therapy on the 1st day after patient admission to ICU

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Ringer's solution; Ringer's solution at an average daily dose of 8.1 ml/kg/day
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	Drug: Reamberin; the balanced succinate-containing crystalloid solution Reamberin (meglumine sodium succinate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality, %	Proportion of patients died during the period of hospital stay	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	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	from date of treatment start until the date of death or the date of discharge from hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	Venous blood Glucose	baseline, day 2, day 3, day 5, day 11
Lactate	Venous blood Lactate	baseline, day 2, day 3, day 5, day 11
pH	Blood gases	baseline, day 2, day 3, day 5, day 11
BE	Blood gases	baseline, day 2, day 3, day 5, day 11
Dynamics of right diaphragm excursion, cm	Diaphragm mobility	baseline, day 2, day 3, day 5, day 11
Total duration of inpatient treatment, days	Total duration of inpatient treatment	from date of treatment start until the date of death or the date of discharge from hospital

Collaborators and Investigators

• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company

Publications and helpful links

Helpful Links

• 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/KMJ2022-364

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; METABOLIC DISORDERS; Respiratory function of the lungs
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Metabolic Diseases
• Other Study ID Numbers: CARECOVID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No