Clinical Study in the Treatment of Patients With Moderate Course of COVID-19

NCT04842435 | Unknown Phase 2

• 1 other identifier: IGK-P-II/III-00-003/2020
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 21

Brief Summary

Study of safety, efficacy and pharmacokinetics, dose selection

Conditions

COVID-19

Keywords

COVID-19; Moderate COVID-19; Pharmacokinetic parameters

Outcome Measures

Primary Outcomes (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

  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)

  7 days

Secondary Outcomes (12)

• All-cause mortality

  28 days

• The elimination time of the SARS-CoV-2 virus

  11 days

• The median time to clinical improvement on the WHO Ordinal Scale for Clinical Improvement

  28 days

• The incidence of severe and extremely severe COVID-19 disease

  28 days

• The need for respiratory support

  28 days

Study Arms (6)

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

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

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

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

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

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

Drug: Placebo

Interventions

COVID-globulin DRUG

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.

Also known as: Anti-coronavirus human immunoglobulin

Stage 1. Group 1; Stage 1. Group 2; Stage 1. Group 3; Stage 2. Group 1

Placebo DRUG

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.

Also known as: 0.9% NaCl solution

Stage 1. Group 4; Stage 2. Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Microgen: lead

Study Sites (21)

9. State Autonomous Healthcare Institution "Professor A. F. Agafonov Republican Clinical Infectious Hospital"

Kazan', Russia

RECRUITING

13. State Budgetary Healthcare Institution "Specialized Clinical Infectious Diseases Hospital" of the Ministry of Health of the Krasnodar Territory

Krasnodar, Russia

RECRUITING

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

TERMINATED

1. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital No. 40 of the Moscow Department of Health"

Moscow, Russia

RECRUITING

14. State Budgetary Institution of Healthcare of Moscow "Infectious Clinical Hospital No. 2" of the Moscow Department of Health

Moscow, Russia

RECRUITING

16. State Budgetary Institution of Healthcare of Moscow "Infectious Clinical Hospital No. 1" of the Moscow Department of Health

Moscow, Russia

RECRUITING

18. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital No. 52 of the Moscow Department of Health"

Moscow, Russia

RECRUITING

19. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital of V.P. Demikhova of the Moscow Department of Health"

Moscow, Russia

RECRUITING

20. State Budgetary Institution of Healthcare of Moscow "Scientific and Research Institute of N.V. Sklifosovskiy of the Moscow Department of Health"

Moscow, Russia

RECRUITING

21. State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital No. 4 of the Moscow Department of Health"

Moscow, Russia

RECRUITING

3. State Budgetary Healthcare Institution of Moscow "City Clinical Hospital No. 24 of the Moscow Department of Health"

Moscow, Russia

RECRUITING

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

TERMINATED

4. Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Health of the Russian Federation

Orenburg, Russia

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, Russia

RECRUITING

5. Saint Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny Region"

Saint Petersburg, Russia

TERMINATED

12. Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation

Samara, Russia

RECRUITING

11. Regional State Budgetary Healthcare Institution "Clinical Hospital No. 1"

Smolensk, Russia

RECRUITING

17. Federal State Budgetary Educational Institution of Higher Education "Bashkiria State Medical University" of the Ministry of Health of the Russian Federation

Ufa, Russia

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, Russia

SUSPENDED

15. Municipal Autonomous Institution "Central City Clinical Hospital No. 24"

Yekaterinburg, Russia

SUSPENDED

2. State Budgetary Institution of Healthcare of the Moscow Region "Zhukovskiy City Clinical Hospital"

Zhukovskiy, Russia

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ekaterina Andreevna Bykova

  JSC "SIC "Microgen"

  STUDY DIRECTOR

Central Study Contacts

Ekaterina Andreevna Bykova

CONTACT

+7 (495) 790-77-73; e.a.bykova@microgen.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 13, 2021
• Study Start: April 12, 2021
• Primary Completion: September 30, 2021
• Study Completion: October 5, 2021
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date
• Access Criteria: Anyone who wishes to access the data

Locations

RU (21)