ClinicalTrials.gov

History of Changes for Study: NCT04842435
Clinical Study in the Treatment of Patients With Moderate Course of COVID-19
Latest version (submitted May 12, 2021) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 April 12, 2021 None (earliest Version on record)
2 April 19, 2021 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures and Study Identification
3 May 12, 2021 Contacts/Locations, Outcome Measures, Study Status, Arms and Interventions, Conditions and Study Description
Comparison Format:

Scroll up to access the controls

Study NCT04842435
Submitted Date:  May 12, 2021 (v3)

Open or close this module Study Identification
Unique Protocol ID: IGK-P-II/III-00-003/2020
Brief Title: Clinical Study in the Treatment of Patients With Moderate Course of COVID-19
Official Title: To Study the Efficacy, Safety and Pharmacokinetics of COVID-globulin, in Addition to Standard Therapy for the Treatment of Patients With a Moderate COVID-19 Form
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2021
Overall Status: Recruiting
Study Start: April 12, 2021
Primary Completion: September 30, 2021 [Anticipated]
Study Completion: October 5, 2021 [Anticipated]
First Submitted: April 12, 2021
First Submitted that
Met QC Criteria:
April 12, 2021
First Posted: April 13, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
May 12, 2021
Last Update Posted: May 14, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Microgen
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: Study of safety, efficacy and pharmacokinetics, dose selection
Detailed Description:

Objective:

To study the efficacy, safety and pharmacokinetics of COVID-globulin, in addition to standard therapy for the treatment of patients with a moderate COVID-19 form.

Study Objectives:

The study comprises two stages, 1 and 2. Stage 1 tasks

  1. to determine and compare the safety parameters of COVID-globulin after a single infusion at doses of 1 mL/kg, 2 mL/kg, 4 mL/kg and placebo in addition to standard therapy in the treatment of patients with COVID-19;
  2. to determine and compare the efficacy parameters of COVID-globulin after a single infusion at doses of 1 mL/kg, 2 mL/kg, 4 mL/kg and placebo in addition to standard therapy in the treatment of patients with COVID-19;
  3. to determine the optimal therapeutic dose of COVID-globulin for the treatment of patients with moderate COVID-19 by comparing the safety and efficacy parameters of doses of 1 mL/kg, 2 mL/kg, 4 mL/kg and placebo;
  4. to study the pharmacokinetic parameters of COVID-globulin in the blood plasma of patients after a single infusion at a dose of 1 mL/kg, 2 mL/kg, 4 mL/kg, in addition to standard therapy for the treatment of patients with moderate COVID-19.

Stage 2 tasks

  1. to study the efficacy of COVID-globulin in addition to standard therapy for the treatment of patients with moderate COVID-19;
  2. to study the safety of COVID-globulin in addition to standard therapy for the treatment of patients with moderate COVID-19;
  3. to conduct a comparative analysis of the efficacy and safety of a group of patients with moderate COVID-19 who receive COVID-globulin in addition to the standard therapy, and a group of patients who receive placebo in addition to standard therapy.
Open or close this module Conditions
Conditions: COVID-19
Keywords: COVID-19
Moderate COVID-19
Pharmacokinetic parameters
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment

Stage 1 study will enroll 156 subjects with moderate COVID-19 who will be randomized into the four groups.

Stage 2 will include 220 subjects who will be divided into two groups.

Number of Arms: 6
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 376 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Stage 1. Group 1
Group 1 - 39 subjects who will receive a single intravenous infusion of COVID-globulin at a dose of 1 mL/kg in addition to standard therapy
Drug: COVID-globulin

In a Stage 1 study, COVID globulin is administered to clinical study subjects randomized to groups 1, 2, or 3 by intravenous drip in one of three doses of 1 mL/kg, 2 mL/kg, or 4 mL/kg The initial drug administration rate is from 0.01 mL/kg to 0.02 mL/kg of body weight per minute for 30 minutes. If the drug is well tolerated, the rate of administration can be gradually increased to a maximum of 0.12 mL/kg of body weight per minute. In order to control the drug administration rate, infusion shall be performed with an infusion pump.

In a Stage 2 study, COVID globulin is administered to clinical study subjects randomized to group 1 by intravenous drip at a dose found optimal based on the results of Stage 1 study.

Other Names:
  • Anti-coronavirus human immunoglobulin
Experimental: Stage 1. Group 2
Group 2 - 39 subjects who will receive a single intravenous infusion of COVID-globulin at a dose of 2 mL/kg in addition to standard therapy
Drug: COVID-globulin

In a Stage 1 study, COVID globulin is administered to clinical study subjects randomized to groups 1, 2, or 3 by intravenous drip in one of three doses of 1 mL/kg, 2 mL/kg, or 4 mL/kg The initial drug administration rate is from 0.01 mL/kg to 0.02 mL/kg of body weight per minute for 30 minutes. If the drug is well tolerated, the rate of administration can be gradually increased to a maximum of 0.12 mL/kg of body weight per minute. In order to control the drug administration rate, infusion shall be performed with an infusion pump.

In a Stage 2 study, COVID globulin is administered to clinical study subjects randomized to group 1 by intravenous drip at a dose found optimal based on the results of Stage 1 study.

Other Names:
  • Anti-coronavirus human immunoglobulin
Experimental: Stage 1. Group 3
Group 3 - 39 subjects who will receive a single intravenous infusion of COVID-globulin at a dose of 4 mL/kg in addition to standard therapy
Drug: COVID-globulin

In a Stage 1 study, COVID globulin is administered to clinical study subjects randomized to groups 1, 2, or 3 by intravenous drip in one of three doses of 1 mL/kg, 2 mL/kg, or 4 mL/kg The initial drug administration rate is from 0.01 mL/kg to 0.02 mL/kg of body weight per minute for 30 minutes. If the drug is well tolerated, the rate of administration can be gradually increased to a maximum of 0.12 mL/kg of body weight per minute. In order to control the drug administration rate, infusion shall be performed with an infusion pump.

In a Stage 2 study, COVID globulin is administered to clinical study subjects randomized to group 1 by intravenous drip at a dose found optimal based on the results of Stage 1 study.

Other Names:
  • Anti-coronavirus human immunoglobulin
Placebo Comparator: Stage 1. Group 4
Group 4 - 39 subjects who will receive a single intravenous infusion of placebo at a dose of 1 mL/kg in addition to standard therapy
Drug: Placebo

In a Stage 1 study, Placebo is administered to clinical study subjects randomized to groups 4 by intravenous drip at a dose of 1 mL/kg.

The initial drug administration rate is from 0.01 mL/kg to 0.02 mL/kg of body weight per minute for 30 minutes. If the drug is well tolerated, the rate of administration can be gradually increased to a maximum of 0.12 mL/kg of body weight per minute. In order to control the drug administration rate, infusion shall be performed with an infusion pump.

In a Stage 2 study, placebo is administered to clinical study subjects randomized to group 2 by intravenous drip at a dose equal to the study drug dose.

Other Names:
  • 0.9% NaCl solution
Active Comparator: Stage 2. Group 1
Group 1 - 110 subjects who will receive a single intravenous infusion of COVID-globulin at a dose defined at Stage 1 in addition to standard therapy
Drug: COVID-globulin

In a Stage 1 study, COVID globulin is administered to clinical study subjects randomized to groups 1, 2, or 3 by intravenous drip in one of three doses of 1 mL/kg, 2 mL/kg, or 4 mL/kg The initial drug administration rate is from 0.01 mL/kg to 0.02 mL/kg of body weight per minute for 30 minutes. If the drug is well tolerated, the rate of administration can be gradually increased to a maximum of 0.12 mL/kg of body weight per minute. In order to control the drug administration rate, infusion shall be performed with an infusion pump.

In a Stage 2 study, COVID globulin is administered to clinical study subjects randomized to group 1 by intravenous drip at a dose found optimal based on the results of Stage 1 study.

Other Names:
  • Anti-coronavirus human immunoglobulin
Placebo Comparator: Stage 2. Group 2
Group 2 - 110 subjects who will receive a single intravenous infusion of placebo at a dose equal to the COVID-globulin dose in addition to standard therapy
Drug: Placebo

In a Stage 1 study, Placebo is administered to clinical study subjects randomized to groups 4 by intravenous drip at a dose of 1 mL/kg.

The initial drug administration rate is from 0.01 mL/kg to 0.02 mL/kg of body weight per minute for 30 minutes. If the drug is well tolerated, the rate of administration can be gradually increased to a maximum of 0.12 mL/kg of body weight per minute. In order to control the drug administration rate, infusion shall be performed with an infusion pump.

In a Stage 2 study, placebo is administered to clinical study subjects randomized to group 2 by intravenous drip at a dose equal to the study drug dose.

Other Names:
  • 0.9% NaCl solution
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The proportion of subjects in the study groups in whom, during the first 7 days after drug administration, one of the following events developed according to the laboratory-instrumental methods or on the basis of a clinical presentation
[ Time Frame: 7 days ]

Laboratory-instrumental methods or on the basis of a clinical presentation:

  • development of acute renal injury stage 2 or higher, assessed by the AKIN (Acute Kidney Injury Network) scale;
  • development of myocardial dysfunction or acute coronary pathology;
  • development of thrombolytic complications;
  • development of a cytokine storm;
  • development of an acute respiratory distress syndrome (ARDS);
  • an increase in the degree of lung lesion, as determined by the CT;
  • negative dynamics of CRP with an increase in the indicator by more than 30 % compared to the baseline value;
  • an increase in the D-dimer indicator by more than 2 times compared with the corresponding indicator at the time of hospitalization;
  • aggravation of clinical symptoms, as determined by the WHO Ordinal Scale, compared with the baseline value.

(Aggravation refers to a decrease in a WHO score by 1 point or more as compared to the value at Visit 1)

Secondary Outcome Measures:
1. All-cause mortality
[ Time Frame: 28 days ]

All-cause mortality (follow-up period of 28 days after the treatment initiation).
2. The elimination time of the SARS-CoV-2 virus
[ Time Frame: 11 days ]

The elimination time of the SARS-CoV-2 virus from the upper respiratory tract (follow-up period of 11 days after the treatment initiation).
3. The median time to clinical improvement on the WHO Ordinal Scale for Clinical Improvement
[ Time Frame: 28 days ]

The median time to clinical improvement on the WHO Ordinal Scale for Clinical Improvement (follow-up period of 28 days after the treatment initiation) using the Hazard Ratio score.
4. The incidence of severe and extremely severe COVID-19 disease
[ Time Frame: 28 days ]

The incidence of severe and extremely severe COVID-19 disease (follow-up period of 28 days after the treatment initiation).
5. The need for respiratory support
[ Time Frame: 28 days ]

The need for respiratory support (follow-up period of 28 days after the treatment initiation).
6. The need for invasive mechanical ventilation of the lungs, ECMO
[ Time Frame: 28 days ]

The need for invasive mechanical ventilation of the lungs, ECMO (follow-up period of 28 days after the treatment initiation).
7. Time to cancellation of oxygen support
[ Time Frame: 28 days ]

Time to cancellation of oxygen support, if any, days (follow-up period of 28 days after the treatment initiation).
8. The need to stay at the intensive care unit
[ Time Frame: 28 days ]

The need to stay at the intensive care unit (follow-up period of 28 days after the treatment initiation).
9. Duration of fever (≥ 380C), days
[ Time Frame: 28 days ]

Duration of fever (≥ 380C), days (follow-up period of 28 days after the treatment initiation).
10. The dynamics of the decrease in points on the NEWS scale
[ Time Frame: 11 days (max. 28 days) ]

The dynamics of the decrease in points on the NEWS scale.

NEWS uses six physiological measurements: respiratory rate; oxygen saturation; temperature; systolic blood pressure; heart rate and level of consciousness. Each scores 0-3 and individual scores are added together for an overall score. An additional one points are added if the patient is receiving oxygen therapy.

Higher scores mean a worse outcome.

11. Dynamical CRP, ferritin, D-dimer values
[ Time Frame: 10 days ]

Dynamical CRP, ferritin, D-dimer values.

Local laboratories of research centers will be used for laboratory tests and assessments.

After collecting and verification 100% values of laboratory parameters according to the Protocol from all local laboratories, the units of measurement will be unified before Statistical process control by valid formulas for transitions.

12. Changes in the degree of lung lesion determined by the CT
[ Time Frame: 7 days ]

Changes in the degree of lung lesion determined by the CT (the result is assessed on the 7th day before the subject is discharged from the hospital compared to the baseline).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Patients who are able to sign the informed consent form to partic-ipate in the clinical study;
  2. Patients of both sexes at the age of 18-65 years of age;
  3. Positive SARS-CoV-2 RNA test result obtained by PCR during the current episode of COVID-19 disease;
  4. One or more clinical manifestations of ARI (acute respiratory infection) or patient complaints: cough (dry or scanty sputum), edema (including during exercise), chest congestion, sore throat, nasal congestion, or mild rhinorrhea, impairment or loss of smell (hyposmia or anosmia), loss of taste (dysgeusia), conjunctivitis, weakness, muscle pain, headache, vomiting, diarrhea, skin manifestations).
  5. Patients with a moderate course of COVID-19, determined on the basis of at least one of the criteria specified in the Interim Guide-lines of the Ministry of Health (assessed from the moment of mani-festation of the disease symptoms):
    • Body Т > 38 °C
    • RR > 22/min
    • SpO2 < 95 % (at the atmospheric air)
    • CRP of the blood serum > 10 mg/L
  6. CT changes typical of viral lesions (minimal or moderate lesion vol-ume; CT 1-2, no more than 72 hours before screening)
  7. Patients meeting the requirements of the Clinical Study Protocol;
  8. Negative pregnancy test (for women with preserved reproductive potential).

Exclusion Criteria:

  1. A history of allergic reactions to human blood products;
  2. Allergic reactions to the components of the study drug;
  3. Hypersensitivity to human immunoglobulin;
  4. Positive direct Coombs test (antiglobulin test);
  5. Condition requiring invasive oxygen support at Screening;
  6. Subjects with mild, severe, extremely severe COVID-19, as well as those at an outpatient treatment and not scheduled for hospitali-zation;
  7. Administration of blood products or blood derivatives within 3 months prior to enrollment;
  8. Administration of any antiviral, immunomodulatory drugs after the manifestation of COVID-19 (except for those to be prescribed dur-ing the study / included in the standard therapy);
  9. Pathology of the immune system (primary and secondary immu-nodeficiencies, deficiency of class A immunoglobulin (IgA) and / or the presence of IgA antibodies, autoimmune diseases);
  10. Child Pugh class B and C liver cirrhosis;
  11. Diabetes mellitus type 1.
  12. Diseases of the thyroid gland with decompensation.
  13. Signs of severe CNS lesions (past serious brain injury, meningitis, history of ischemic stroke, encephalopathy of various etiologies, epilepsy, etc.);
  14. Serious blood diseases, current or in the history (for example, baseline anemia Hb < 80, myeloid leukemia, myelodysplastic syn-drome, etc.);
  15. The period after the coronary artery bypass grafting / stenting of at least 3 months prior to enrollment;
  16. Malignant neoplasm of any localization at present or within 5 years before enrollment into the study, except for completely healed carcinoma in situ;
  17. Conditions and diseases, other than COVID-19, known from anam-nesis, accompanied by blood hypercoagulability syndrome and a trend for thrombosis (such as sickle cell anemia, polycythemia, hemostatic disorders);
  18. Severe dyslipidemia in the history;
  19. Disseminated intravascular coagulation syndrome, thrombosis and thromboembolism of any localization, known from the history;
  20. CKD-EPI GFR < 30 mL/min at screening;
  21. History of chronic III-IV FC heart failure;
  22. Pregnancy or lactation;
  23. Participation in any other clinical study within the last 3 months;
  24. A history of tuberculosis, cancer or a positive reaction to HIV infec-tion, hepatitis B and C, syphilis according to the history;
  25. Impossibility of intravenous administration of the drug;
  26. Severe visual and/or hearing impairments, severe speech impair-ments and/or other abnormalities that may prevent the patient from adequate cooperation during the study);
  27. Mental diseases in the history;
  28. A history of alcohol, drug or medicinal product abuse;
  29. Patients who, in the opinion of the investigator, are clearly or likely to be unable to understand and evaluate the information on this study within the informed consent signing process, in particular regarding the expected risks and possible discomfort;
  30. Other diseases, symptoms or conditions not listed above that can be an obstacle to participation in a clinical study in the investiga-tor's opinion.
Open or close this module Contacts/Locations
Central Contact Person: Ekaterina Andreevna Bykova
Telephone: +7 (495) 790-77-73 Ext. 4002
Email: e.a.bykova@microgen.ru
Study Officials: Ekaterina Andreevna Bykova
Study Director
JSC "SIC "Microgen"
Locations: Russian Federation
15. Municipal Autonomous Institution "Central City Clinical Hospital No. 24"
[Suspended]
Ekaterinburg, Russian Federation
9. State Autonomous Healthcare Institution "Professor A. F. Agafonov Republican Clinical Infectious Hospital"
[Recruiting]
Kazan, Russian Federation
Contact:Contact: Khalit Saubanovich Khaertynov khalit65@yandex.ru
13. State Budgetary Healthcare Institution "Specialized Clinical Infectious Diseases Hospital" of the Ministry of Health of the Krasnodar Territory
[Recruiting]
Krasnodar, Russian Federation
Contact:Contact: Viktoriya Aleksandrovna Bahtina dom-167@mail.ru
6. State Budgetary Healthcare Institution "Scientific and Research Institute Professor S. V. Ochapovskiy Territorial Clinical Hospital" of the Ministry of Health of the Krasnodar Territory
[Terminated]
Krasnodar, Russian Federation
1. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital No. 40 of the Moscow Department of Health"
[Recruiting]
Moscow, Russian Federation
Contact:Contact: Denis Nikolaevich Protsenko drprotsenko@me.com
14. State Budgetary Institution of Healthcare of Moscow "Infectious Clinical Hospital No. 2" of the Moscow Department of Health
[Recruiting]
Moscow, Russian Federation
Contact:Contact: Irina Viktorovna Shestakova prof.shеstаkоvа@уапdех.ru
16. State Budgetary Institution of Healthcare of Moscow "Infectious Clinical Hospital No. 1" of the Moscow Department of Health
[Recruiting]
Moscow, Russian Federation
Contact:Contact: Dmitriy Alekseevich Bistrickiy BistritskiyDA@ikb1.ru
18. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital No. 52 of the Moscow Department of Health"
[Recruiting]
Moscow, Russian Federation
Contact:Contact: Daria Sergeevna Fomina daria.s.fomina@gmail.ru
19. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital of V.P. Demikhova of the Moscow Department of Health"
[Recruiting]
Moscow, Russian Federation
Contact:Contact: Elena Aleksandrovna Zolotova zolotova_ea@mail.ru
20. State Budgetary Institution of Healthcare of Moscow "Scientific and Research Institute of N.V. Sklifosovskiy of the Moscow Department of Health"
[Recruiting]
Moscow, Russian Federation
Contact:Contact: Vladimir Vital'evich Kulabukhov vkulabukhov@qmail.com
21. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital No. 4 of the Moscow Department of Health"
[Recruiting]
Moscow, Russian Federation
Contact:Contact: Karine Arnoldovna Lytkina Lytkina.k@mail.ru
3. State Budgetary Healthcare Institution of Moscow "City Clinical Hospital No. 24 of the Moscow Department of Health"
[Recruiting]
Moscow, Russian Federation
Contact:Contact: Grigoriy Vladimirovich Rodoman prof.rodoman@gmail.com
7. Federal State Budgetary Institution "Central Clinical Hospital with an Outpatient Facility" of the Administrative Directorate of the President of the Russian Federation
[Terminated]
Moscow, Russian Federation
4. Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Health of the Russian Federation
[Recruiting]
Orenburg, Russian Federation
Contact:Contact: Aleksandr Sergeevich Pan'kov apankov@rambler.ru
10. Federal State Budgetary Educational Institution of Higher Education "Academician I. P. Pavlov Ryazan State Medical University" of the Ministry of Health of the Russian Federation
[Recruiting]
Ryazan', Russian Federation
Contact:Contact: Viktor Borisovich Filimonov filimonov1974@mail.ru
5. Saint Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny Region"
[Terminated]
Saint Petersburg, Russian Federation
12. Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation
[Recruiting]
Samara, Russian Federation
Contact:Contact: Dmitriy Yur'evich Konstantinov dk.samgmu@mail.ru
11. Regional State Budgetary Healthcare Institution "Clinical Hospital No. 1"
[Recruiting]
Smolensk, Russian Federation
Contact:Contact: Aleksandr Alekseevich Punin 001e316@mail.ru
17. Federal State Budgetary Educational Institution of Higher Education "Bashkiria State Medical University" of the Ministry of Health of the Russian Federation
[Suspended]
Ufa, Russian Federation
8. State Budgetary Healthcare Institution of the Yaroslavl Region "Yaroslavl Regional Clinical Hospital of War Veterans - International Center for Problems of the Elderly "Zdorovoye Dolgoletiye"
[Suspended]
Yaroslavl, Russian Federation
2. State Budgetary Institution of Healthcare of the Moscow Region "Zhukovskiy City Clinical Hospital"
[Recruiting]
Zhukovskiy, Russian Federation
Contact:Contact: Elena Petrovna Dmitrikova dmitrikovaep@gmail.com
Open or close this module IPDSharing
Plan to Share IPD: Yes
All of the individual participant data collected during the trial, after deidentification
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame:
Immediately following publication. No end date
Access Criteria:
Anyone who wishes to access the data
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services