Clinical Study in the Treatment of Patients With Moderate Course of COVID-19
NCT ID: NCT04842435
Last Updated: 2021-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
376 participants
INTERVENTIONAL
2021-04-12
2021-10-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Stage 2 will include 220 subjects who will be divided into two groups.
TREATMENT
DOUBLE
Study Groups
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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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Microgen
OTHER
Responsible Party
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Principal Investigators
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Ekaterina Andreevna Bykova
Role: STUDY_DIRECTOR
JSC "SIC "Microgen"
Locations
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9. State Autonomous Healthcare Institution "Professor A. F. Agafonov Republican Clinical Infectious Hospital"
Kazan', , Russia
13. State Budgetary Healthcare Institution "Specialized Clinical Infectious Diseases Hospital" of the Ministry of Health of the Krasnodar Territory
Krasnodar, , Russia
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
Krasnodar, , Russia
1. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital No. 40 of the Moscow Department of Health"
Moscow, , Russia
14. State Budgetary Institution of Healthcare of Moscow "Infectious Clinical Hospital No. 2" of the Moscow Department of Health
Moscow, , Russia
16. State Budgetary Institution of Healthcare of Moscow "Infectious Clinical Hospital No. 1" of the Moscow Department of Health
Moscow, , Russia
18. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital No. 52 of the Moscow Department of Health"
Moscow, , Russia
19. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital of V.P. Demikhova of the Moscow Department of Health"
Moscow, , Russia
20. State Budgetary Institution of Healthcare of Moscow "Scientific and Research Institute of N.V. Sklifosovskiy of the Moscow Department of Health"
Moscow, , Russia
21. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital No. 4 of the Moscow Department of Health"
Moscow, , Russia
3. State Budgetary Healthcare Institution of Moscow "City Clinical Hospital No. 24 of the Moscow Department of Health"
Moscow, , Russia
7. Federal State Budgetary Institution "Central Clinical Hospital with an Outpatient Facility" of the Administrative Directorate of the President of the Russian Federation
Moscow, , Russia
4. Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Health of the Russian Federation
Orenburg, , Russia
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
Ryazan, , Russia
5. Saint Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny Region"
Saint Petersburg, , Russia
12. Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation
Samara, , Russia
11. Regional State Budgetary Healthcare Institution "Clinical Hospital No. 1"
Smolensk, , Russia
17. Federal State Budgetary Educational Institution of Higher Education "Bashkiria State Medical University" of the Ministry of Health of the Russian Federation
Ufa, , Russia
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"
Yaroslavl, , Russia
15. Municipal Autonomous Institution "Central City Clinical Hospital No. 24"
Yekaterinburg, , Russia
2. State Budgetary Institution of Healthcare of the Moscow Region "Zhukovskiy City Clinical Hospital"
Zhukovskiy, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IGK-P-II/III-00-003/2020
Identifier Type: -
Identifier Source: org_study_id
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