COVID-19Phase 2/3NCT04842435
Clinical Study in the Treatment of Patients With Moderate Course of COVID-19
A Phase 2/3 study testing COVID-globulin in people with COVID-19, run by Microgen at 21 sites in Russia.
Trial summary
Study of safety, efficacy and pharmacokinetics, dose selection Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- COVID-globulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 376 participants
- Where
- 21 sitesRussia
- Study dates
- 12 Apr 2021to 5 Oct 2021
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are able to sign the informed consent form to partic-ipate in the clinical study;
- Patients of both sexes at the age of 18-65 years of age;
- Positive SARS-CoV-2 RNA test result obtained by PCR during the current episode of COVID-19 disease;
- 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).
- 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
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- RR > 22/min
- SpO2 < 95 % (at the atmospheric air)
- CRP of the blood serum > 10 mg/L
- CT changes typical of viral lesions (minimal or moderate lesion vol-ume; CT 1-2, no more than 72 hours before screening)
- Patients meeting the requirements of the Clinical Study Protocol;
- Negative pregnancy test (for women with preserved reproductive potential).
Who cannot join
- A history of allergic reactions to human blood products;
- Allergic reactions to the components of the study drug;
- Hypersensitivity to human immunoglobulin;
- Positive direct Coombs test (antiglobulin test);
- Condition requiring invasive oxygen support at Screening;
- Subjects with mild, severe, extremely severe COVID-19, as well as those at an outpatient treatment and not scheduled for hospitali-zation;
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- Administration of blood products or blood derivatives within 3 months prior to enrollment;
- 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);
- 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);
- Child Pugh class B and C liver cirrhosis;
- Diabetes mellitus type 1.
- Diseases of the thyroid gland with decompensation.
- Signs of severe CNS lesions (past serious brain injury, meningitis, history of ischemic stroke, encephalopathy of various etiologies, epilepsy, etc.);
- Serious blood diseases, current or in the history (for example, baseline anemia Hb < 80, myeloid leukemia, myelodysplastic syn-drome, etc.);
- The period after the coronary artery bypass grafting / stenting of at least 3 months prior to enrollment;
- Malignant neoplasm of any localization at present or within 5 years before enrollment into the study, except for completely healed carcinoma in situ;
- 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);
- Severe dyslipidemia in the history;
- Disseminated intravascular coagulation syndrome, thrombosis and thromboembolism of any localization, known from the history;
- CKD-EPI GFR < 30 mL/min at screening;
- History of chronic III-IV FC heart failure;
- Pregnancy or lactation;
- Participation in any other clinical study within the last 3 months;
- A history of tuberculosis, cancer or a positive reaction to HIV infec-tion, hepatitis B and C, syphilis according to the history;
- Impossibility of intravenous administration of the drug;
- 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);
- Mental diseases in the history;
- A history of alcohol, drug or medicinal product abuse;
- 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;
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Russia21 sites, 15 recruiting
- Recruiting
9. State Autonomous Healthcare Institution "Professor A. F. Agafonov Republican Clinical Infectious Hospital"
Kazan'
Khalit Saubanovich Khaertynov, khalit65@yandex.ru
- Recruiting
13. State Budgetary Healthcare Institution "Specialized Clinical Infectious Diseases Hospital" of the Ministry of Health of the Krasnodar Territory
Krasnodar
Viktoriya Aleksandrovna Bahtina, dom-167@mail.ru
- Terminated
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
- Recruiting
1. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital No. 40 of the Moscow Department of Health"
Moscow
Denis Nikolaevich Protsenko, drprotsenko@me.com
- Recruiting
14. State Budgetary Institution of Healthcare of Moscow "Infectious Clinical Hospital No. 2" of the Moscow Department of Health
Moscow
Irina Viktorovna Shestakova, prof.shеstаkоvа@уапdех.ru
- Recruiting
16. State Budgetary Institution of Healthcare of Moscow "Infectious Clinical Hospital No. 1" of the Moscow Department of Health
Moscow
Dmitriy Alekseevich Bistrickiy, BistritskiyDA@ikb1.ru
- Recruiting
18. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital No. 52 of the Moscow Department of Health"
Moscow
Daria Sergeevna Fomina, daria.s.fomina@gmail.ru
- Recruiting
19. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital of V.P. Demikhova of the Moscow Department of Health"
Moscow
Elena Aleksandrovna Zolotova, zolotova_ea@mail.ru
- Recruiting
20. State Budgetary Institution of Healthcare of Moscow "Scientific and Research Institute of N.V. Sklifosovskiy of the Moscow Department of Health"
Moscow
Vladimir Vital'evich Kulabukhov, vkulabukhov@qmail.com
- Recruiting
21. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital No. 4 of the Moscow Department of Health"
Moscow
Karine Arnoldovna Lytkina, Lytkina.k@mail.ru
- Recruiting
3. State Budgetary Healthcare Institution of Moscow "City Clinical Hospital No. 24 of the Moscow Department of Health"
Moscow
Grigoriy Vladimirovich Rodoman, prof.rodoman@gmail.com
- Terminated
7. Federal State Budgetary Institution "Central Clinical Hospital with an Outpatient Facility" of the Administrative Directorate of the President of the Russian Federation
Moscow
- Recruiting
4. Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Health of the Russian Federation
Orenburg
Aleksandr Sergeevich Pan'kov, apankov@rambler.ru
- Recruiting
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
Viktor Borisovich Filimonov, filimonov1974@mail.ru
- Terminated
5. Saint Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny Region"
Saint Petersburg
- Recruiting
12. Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation
Samara
Dmitriy Yur'evich Konstantinov, dk.samgmu@mail.ru
- Recruiting
11. Regional State Budgetary Healthcare Institution "Clinical Hospital No. 1"
Smolensk
Aleksandr Alekseevich Punin, 001e316@mail.ru
- Suspended
17. Federal State Budgetary Educational Institution of Higher Education "Bashkiria State Medical University" of the Ministry of Health of the Russian Federation
Ufa
- Suspended
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
- Suspended
15. Municipal Autonomous Institution "Central City Clinical Hospital No. 24"
Yekaterinburg
- Recruiting
2. State Budgetary Institution of Healthcare of the Moscow Region "Zhukovskiy City Clinical Hospital"
Zhukovskiy
Elena Petrovna Dmitrikova, dmitrikovaep@gmail.com
About this study
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
Study of safety, efficacy and pharmacokinetics, dose selection
Read the 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
- 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;
- 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;
- 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;
- 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
- to study the efficacy of COVID-globulin in addition to standard therapy for the treatment of patients with moderate COVID-19;
- to study the safety of COVID-globulin in addition to standard therapy for the treatment of patients with moderate COVID-19;
- 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
- COVID-19
- Being tested
- COVID-globulin, Placebo
- Keywords
- COVID-19, Moderate COVID-19, Pharmacokinetic parameters
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-globulinDrug
Also called Anti-coronavirus human immunoglobulin
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.
PlaceboDrug
Also called 0.9% NaCl solution
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.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1. Group 1 | Experimental | 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 Receives: Drug: COVID-globulin |
| Stage 1. Group 2 | Experimental | 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 Receives: Drug: COVID-globulin |
| Stage 1. Group 3 | Experimental | 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 Receives: Drug: COVID-globulin |
| Stage 1. Group 4 | Placebo comparator | 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 Receives: Drug: Placebo |
| Stage 2. Group 1 | Active comparator | 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 Receives: Drug: COVID-globulin |
| Stage 2. Group 2 | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
Measured: 7 days
Secondary outcomes (12)
All-cause mortality
All-cause mortality (follow-up period of 28 days after the treatment initiation).
Measured: 28 days
The elimination time of the SARS-CoV-2 virus
The elimination time of the SARS-CoV-2 virus from the upper respiratory tract (follow-up period of 11 days after the treatment initiation).
Measured: 11 days
The median time to clinical improvement on the WHO Ordinal Scale for Clinical Improvement
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.
Measured: 28 days
The incidence of severe and extremely severe COVID-19 disease
The incidence of severe and extremely severe COVID-19 disease (follow-up period of 28 days after the treatment initiation).
Measured: 28 days
The need for respiratory support
The need for respiratory support (follow-up period of 28 days after the treatment initiation).
Measured: 28 days
The need for invasive mechanical ventilation of the lungs, ECMO
The need for invasive mechanical ventilation of the lungs, ECMO (follow-up period of 28 days after the treatment initiation).
Measured: 28 days
Time to cancellation of oxygen support
Time to cancellation of oxygen support, if any, days (follow-up period of 28 days after the treatment initiation).
Measured: 28 days
The need to stay at the intensive care unit
The need to stay at the intensive care unit (follow-up period of 28 days after the treatment initiation).
Measured: 28 days
Duration of fever (≥ 380C), days
Duration of fever (≥ 380C), days (follow-up period of 28 days after the treatment initiation).
Measured: 28 days
The dynamics of the decrease in points on the NEWS scale
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.
Measured: 11 days (max. 28 days)
Dynamical CRP, ferritin, D-dimer values
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.
Measured: 10 days
Changes in the degree of lung lesion determined by the CT
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).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start12 Apr 2021
- Primary completion30 Sep 2021 (estimated)
- Study completion5 Oct 2021 (estimated)
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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Microgen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ekaterina Andreevna Bykova, Study director, JSC "SIC "Microgen"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842435
- Sponsor's protocol ID
- IGK-P-II/III-00-003/2020
- Status last verified
- May 2021
- First submitted
- 12 Apr 2021
- Last updated
- 14 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04842435
- Acronym / sponsor ID
- IGK-P-II/III-00-003/2020
- Conditions
- COVID-19
- Keywords
- COVID-19, Moderate COVID-19, Pharmacokinetic parameters
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- MicrogenUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 5 Oct 2021 (estimated)
- First posted
- 13 Apr 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.
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
- 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;
- 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;
- 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;
- 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
- to study the efficacy of COVID-globulin in addition to standard therapy for the treatment of patients with moderate COVID-19;
- to study the safety of COVID-globulin in addition to standard therapy for the treatment of patients with moderate COVID-19;
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stage 1. Group 1 | Experimental | Drug: COVID-globulinGroup 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 |
| Stage 1. Group 2 | Experimental | Drug: COVID-globulinGroup 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 |
| Stage 1. Group 3 | Experimental | Drug: COVID-globulinGroup 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 |
| Stage 1. Group 4 | Placebo comparator | Drug: PlaceboGroup 4 - 39 subjects who will receive a single intravenous infusion of placebo at a dose of 1 mL/kg in addition to standard therapy |
| Stage 2. Group 1 | Active comparator | Drug: COVID-globulinGroup 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 |
| Stage 2. Group 2 | Placebo comparator | Drug: PlaceboGroup 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who are able to sign the informed consent form to partic-ipate in the clinical study;
- Patients of both sexes at the age of 18-65 years of age;
- Positive SARS-CoV-2 RNA test result obtained by PCR during the current episode of COVID-19 disease;
- 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).
- 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):
Key exclusion criteria (30 listed)
- A history of allergic reactions to human blood products;
- Allergic reactions to the components of the study drug;
- Hypersensitivity to human immunoglobulin;
- Positive direct Coombs test (antiglobulin test);
- Condition requiring invasive oxygen support at Screening;
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 |
|---|---|---|
| COVID-globulinAlso: Anti-coronavirus human immunoglobulinIn 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. | Drug | Stage 1. Group 1, Stage 1. Group 2, Stage 1. Group 3, Stage 2. Group 1 |
| PlaceboAlso: 0.9% NaCl solutionIn 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. | Drug | Stage 1. Group 4, Stage 2. Group 2 |
Primary outcome
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)
12 secondary outcomes
All-cause mortality
Time frame: 28 days
The elimination time of the SARS-CoV-2 virus
Time frame: 11 days
The median time to clinical improvement on the WHO Ordinal Scale for Clinical Improvement
Time frame: 28 days
The incidence of severe and extremely severe COVID-19 disease
Time frame: 28 days
The need for respiratory support
Time frame: 28 days
The need for invasive mechanical ventilation of the lungs, ECMO
Time frame: 28 days
Time to cancellation of oxygen support
Time frame: 28 days
The need to stay at the intensive care unit
Time frame: 28 days
Duration of fever (≥ 380C), days
Time frame: 28 days
The dynamics of the decrease in points on the NEWS scale
Time frame: 11 days (max. 28 days)
Dynamical CRP, ferritin, D-dimer values
Time frame: 10 days
Changes in the degree of lung lesion determined by the CT
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification
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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.
Ekaterina Andreevna Bykova study director
JSC "SIC "Microgen"
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing COVID-globulin in people with COVID-19, run by Microgen at 21 sites 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 12 inclusion and 30 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 14 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 21 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ekaterina Andreevna Bykova (+7 (495) 790-77-73 ext. 4002, e.a.bykova@microgen.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 14 May 2021.