Covid19Phase 3NCT04500067
Intravenous Immunoglobulin (IVIG, Bioven) Efficacy Assess for COVID-19 / SARS-CoV-2 Severe Pneumonia Complex Treatment
A Phase 3 study testing IVIG in people with Covid19 and Pneumonia, run by Biopharma Plasma LLC at 9 sites in Ukraine.
Trial summary
Pneumonia caused by coronavirus infection COVID-19 is characterized by a combination of several dangerous factors that consistently worsen the patient's condition: viral lung damage early in the disease; a sharp increase in inflammation on the background of an unbalanced immune response ("cytokine storm"); joining a… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- IVIG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 9 sitesUkraine
- Study dates
- 7 May 2020to 15 Sep 2020
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18 years of age and older;
- COVID-19 documentary confirmed by PCR lab test;
- severe pneumonia caused by COVID-19 according to the criteria below:
- - fever or suspicion of respiratory infection;
- - the number of respiratory movements 30 per 1 min and above;
- - severe respiratory failure or SpO2 <90% with spontaneous breathing indoors;
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- - the presence of foci of inflammation in the lungs according to the results of computed tomography, which is documented.
- or if any of the conditions listed below have developed on the background of previously diagnosed coronavirus pneumonia:
- - severe respiratory failure required mechanical ventilation (ALV);
- - acute respiratory distress syndrome according to WHO diagnostic criteria (development within one week after the manifestation of disease clinical symptoms or emergence of new ones or deterioration of respiratory syndromes. Chest visualization (lung X-ray, CT or ultrasound); bilateral opacities not fully explaining the gravity of condition or lung collapse or nodules);
- - sepsis according to WHO diagnostic criteria (life-threatening organ dysfunction caused by disturbance of host reaction to suspected or proven infection. The features of organ dysfunction include the following: mental change, labored or shallow breathing, low oxygenation, oliguria or anuria, rapid heart palpitation, weak pulse, cold extremities or low blood pressure, skin blotching or lab-proven coagulopathy, thrombocytopenia, acidosis, high level of lactic acid or hyperbilirubinemia);
- - endotoxic shock according to WHO diagnostic criteria (persisting hypotension despite extensive resuscitation requiring vasoconstrictors for maintaining mean arterial pressure ≥ 65 mmHg and serum lactate level > 2 mmol/l);
- the signed patient's informed consent to participation in the trial;
- the negative pregnancy test (for female patients of reproductive age), readiness to use reliable contraception methods during the whole duration of the trial.
- the ability, according to the researcher, to follow all requirements of the research protocol.
- this study allows you to take into account the results of examinations related to the disease, conducted within 10 days before signing the Informed Consent. Such data are transferred from the primary documentation to the CRF.
Who cannot join
- known intolerance to plasma or immunoglobulin drugs;
- drug allergy or hypersensitization to immunoglobulin drugs;
- any known counter-indication to immunoglobulin drugs according to the instruction for medical application of the tested drug;
- pneumonia not associated with COVID-19 infection;
- pregnancy, lactation period;
- any clinically significant impairment of liver function (elevation of serum transaminase levels more than 3 times the upper limit of normal);
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- serum creatinine levels more than 2 times the upper limit of normal for a given age and gender;
- established diagnosis of primary immunodeficiency;
- verified HIV-infection;
- immune diseases (blood immune diseases, rheumatic diseases, nephritis, etc.)
- severe cardiovascular failure (Stage III);
- mental illness in anamnesis;
- the need for prescribing medicines or procedures that are incompatible with the administration of the drug within the scope of this study: monoclonal antybodies;
- known drug addiction;
- participation in any other clinical trial presently or within the last 30 days.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Ukraine9 sites
Site 02 - "Bila Tserkva City Hospital №3"
Bila Tserkva, Kyiv Oblast, 09112
Site 08 - "Central City Clinical Hospital of Ivano-Frankivsk City Council"
Ivano-Frankivsk, Ivano-Frankivs'k Region, 76018
Site 01 - "Kyiv City Clinical Hospital №17"
Kyiv, 03110
Site 05 - "Kyiv City Clinical Hospital №4"
Kyiv, 03110
Site 09 - "Volyn Regional Clinical Hospital"
Lutsk, Volyn Oblast, 43000
Site 03 - "Lviv Regional Infectious Diseases Clinical Hospital"
Lviv, Lviv Oblast, 79010
Site 04 - "City Clinical Infectious Diseases Hospital", Odesa
Odesa, Odesa Oblast, 65021
Site 07 - "Ternopil City Municipal Ambulance Hospital"
Ternopil, Ternopil Oblast, 46006
Site 06 - "Vinnytsia City Clinical Hospital №1"
Vinnitsia, Vinnitsia Region, 21021
About this study
Official title: An Open-label Multicenter Randomized Trial to Evaluate the Efficacy of Bioven, Manufactured by Biopharma Plasma, LLC, in Complex Therapy of Patients With Pneumonia Induced by COVID-19 / SARS-CoV-2
Pneumonia caused by coronavirus infection COVID-19 is characterized by a combination of several dangerous factors that consistently worsen the patient's condition: viral lung damage early in the disease; a sharp increase in inflammation on the background of an unbalanced immune response ("cytokine storm"); joining a bacterial infection.
The condition of patients deteriorates significantly mostly at cytokine storm development. The damaging of a large volume of lung tissue leads to develops of respiratory failure, respiratory distress syndrome, or shock. Ventilatory support becomes ineffective and patients die.
Read more
There are reports of the effectiveness of Human Normal Immunoglobulin for Intravenous Administration (IVIG) high doses when used as part of complex therapy in patients with pneumonia caused by coronavirus COVID-19. In particular, IVIG has a positive effect on survival rates, overall disease course, duration of stay in the intensive care unit, and ventilatory support duration.
The probable mechanism of action of high-dose IVIG therapy is considered to be a regulatory effect on the immune system. Similar is the known and confirmed effectiveness of IVIG for autoimmune diseases (Kavasaky disease, Guillain Barre syndrome, Chronic inflammatory demyelinating polyradiculoneuropathy, Multifocal motor neuropathy).
This trial to assesses the Efficacy of IVIG (medication trade name - Bioven, manufactured by Biopharma Plasma LLC) in the High Immunomodulatory Dose in Complex Treatment of Severe Pneumonia Caused by COVID-19 / SARS-CoV-2
Read the detailed description
The screening stage:
The patient or his legal representative must sign an informed consent. After signing the informed consent, the screening tests\&procedures are performed and the compliance with the inclusion / non-inclusion criteria is assessed.
For patients who have been screened and meet the inclusion criteria and do not fall under the exclusion criteria, a blinded randomization procedure is provided.
Randomization is performed by the IVRS method, according to the blinded-block patient's randomization table.
The clinical stage of the trial:
Begins after patient randomization. At the clinical stage, among other things, provides:
- Determination of the individual dose of the study drug (in the study group)
- Administration of the drug (in the study group)
- Registration of adverse events
- registration of information about taking antiviral drugs for the treatment of COVID-19;
- registration of information on symptomatic therapy and administration of drugs for the treatment of comorbidities;
- measurement of vital signs (blood pressure, heart rate, respiratory rate, body temperature);
- Determination of SPO2 level
- Determining the need for ventilation
- Determining the need for intensive care
- Assessment of compliance with the exclusion criteria
Patients in the Control Group will receive therapy recommended by the COVID-19 coronavirus infection treatment protocol, depending on the severity of their condition according to the prescribing list, which will not include immunoglobulin preparations.
Patients of the Study Group (IVIG) receive high-dose therapy with the study drug (Bioven, 10% solution for infusions produced by Biopharma Plasma LLC, Ukraine). The dose is calculated by body weight. Patients will also receive therapy recommended by the COVID-19 coronavirus infection treatment protocol, depending on the severity of their condition according to the prescribing list.
Bioven administered intravenously, at an initial rate of 0.5 - 1.0 ml/kg body weight/hour for 30 minutes. In the absence of any undesirable side effects, the rate of administration can be gradually increased (recommended increase by 0.5 - 1.5 ml/kg body weight/hour every 10 minutes). According to results previously accomplished clinical studies, the maximum rate of Bioven administration is up to 8.5 ml/kg body weight/hour.
Observation and completion stage:
Begins and continues from the last administration of the study drug until the discharge of the patient from the hospital, but not less than 28 days from the confirmation of the diagnosis of pneumonia caused by coronavirus infection COVID-19.
The following procedures are provided at the stage:
- registration of information about taking antiviral drugs for the treatment of COVID-19;
- registration of information on symptomatic therapy and administration of drugs for the treatment of comorbidities;
- measurement of vital signs (blood pressure, heart rate, respiratory rate, body temperature);
- determination of SPO2 level
- registration of the results of the examination of the lungs by computed tomography (or radiography)
- taking biomaterials for laboratory research:
- general blood test (erythrocytes, hemoglobin, expanded leukocyte formula, platelets, etc.);
- general analysis of urine;
- biochemical analysis of blood;
- state of the coagulation system
- determination of inflammatory factors in the dynamics (CRP, ferritin, procalcitonin; TNF-α), IL-1-beta, IL-6, complement component C3 (C3), circulating immune complexes (CIC), etc.),
- determination of IgG subclasses (G1, G2, G3, G4,);
- Determining the need for ventilation
- Determining the need for intensive care
- Adverse reactions registration
- Assessment of compliance with the exclusion criteria
The patient's condition is assessed daily till discharge; and by schedule after discharge (if it happen earlier), during 28 days period after diagnosis of severe pneumonia caused by coronavirus infection COVID-19 In case of death of the patient - the date and cause of death are fixed. The results of the study are evaluated by endpoints.
- Being tested
- IVIG
- Keywords
- Pneumonia, COVID-19, SARS-CoV-2, IVIG, Immunoglobulin for Intravenous Administration, Bioven, Coronavirus
- Medical subject headings
- COVID-19, Pneumonia, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIGDrug
Also called Human normal immunoglobulin for intravenous administration, Bioven
Patients in the study group receive the drug Bioven, 10% solution for infusions produced by LLC Biopharma Plasma 0,8-1,0 g/kg once a day for 2 days (total course dose - 1.6-2.0 g/kg) as well as base treatment recommended by the protocol of COVID-19 coronavirus infection treatment depending on the severity of their condition according to the prescription sheet.
| Study group | Role | What they receive |
|---|---|---|
| Study Group (IVIG) | Experimental | Patients receive IVIG (trade name - Bioven) with base therapy Receives: Drug: IVIG |
| Control group | No intervention | Patients receive base therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period duration (in days) to clinical improvement
Number of days post-onset of severe pneumonia to the moment of normalization at least two from following primary outcomes: O2 saturation with self-breathing, respiratory movements rate with self-breathing, body temperature without antipyretics use, lymphocyte count (targeted levels set in the description each of these primary outcomes)
Measured: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days
O2 saturation (SPO2 percentage), with self-breathing
The target level of SPO2 percentage - 95% and above with self-breathing, is used as one of the clinical improvement criteria
Measured: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days
Respiratory movements rate (amount per minute), with self-breathing
The target level of respiratory movements - 28 per minute or less with self-breathing, is used as one of the clinical improvement criteria
Measured: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days
Body temperature without antipyretics use
Measured in degrees Celsius. Fever absence (body temperature no more 37 degrees Celsius) during at least 24 hours without antipyretics, is used as one of the clinical improvement criteria.
Measured: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days
Lymphocyte count
The target level 1000 cells / mm3 and above is used as one of the clinical improvement criteria (applicable for patients with lymphocytes count lower 1000 cells / mm3 at screening moment)
Measured: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days
Secondary outcomes (15)
Time from the onset of the disease to discharge, in days
Period duration (in days)
Measured: 28 days
Duration of the need for ventilatory support, in days
Number of days with ventilatory support
Measured: 28 days
Duration of the need for intensive care, in days
Number of days in the intensive care unit
Measured: 28 days
Duration of need for oxygenation in days (SPO2 ≤ 93% with self-breathing)
Number of days with necessery of oxygenation support
Measured: 28 days
The C-reactive protein (CRP) level
Measuring the analyte concentration in plasma (mg/L)
Measured: Day 0 (screening), day 5, day 14, day 28
The tumor necrozis factor alpha (TNF-α) level
Measuring the analyte concentration in plasma (pg/mL)
Measured: Day 0 (screening), day 5, day 14, day 28
The interleukin-1β (IL-1β) level
Measuring the analyte concentration in plasma (pg/mL)
Measured: Day 0 (screening), day 5, day 14, day 28
The interleukin-6 (IL-6) level
Measuring the analyte concentration in plasma (pg/mL)
Measured: Day 0 (screening), day 5, day 14, day 28
The D-dimer level
Measuring the analyte concentration in plasma (µg FEU/mL)
Measured: Day 0 (screening), day 5, day 14, day 28
The Complement (C3 component) level
Measuring the analyte concentration in plasma (g/L)
Measured: Day 0 (screening), day 5, day 14, day 28
The Circulating immune complexes level
Measuring the analyte concentration in plasma (U/mL)
Measured: Day 0 (screening), day 5, day 14, day 28
The ferritin level
Analyte concentration in plasma (ng/mL)
Measured: Day 0 (screening), day 5, day 14, day 28
The procalcitonin level
Analyte concentration in plasma (ng/mL)
Measured: Day 0 (screening), day 5, day 14, day 28
IgG subtypes
The IgG-subtypes (IgG1-IgG4) concentration in plasma (mg/dL)
Measured: Day 0 (screening), day 5, day 14, day 28
Survival assessment for a 28-day follow-up period since the onset of severe pneumonia
Survivealance estimation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start7 May 2020
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label multicenter randomized controlled in parallel groups. Patients undergoing screening are randomized into groups in equal proportions: * Study Group (receive IVIG Bioven with base therapy). * Control group (receive base therapy only) At the stage of Data Analysis to ensure comparability of data and homogeneity of the sample, the possibility of additional comparison of groups based on the actually prescribed base therapy and other identified covariates is provided.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biopharma Plasma LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lviv National Medical University, Vinnitsa National Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500067
- Sponsor's protocol ID
- 2020-BV-BP
- Status last verified
- Oct 2020
- First submitted
- 15 Jul 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of the trial, results will be published. Access to parts CSR planned after the release of scientific publications
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Multicenter Randomized Trial to Evaluate the Efficacy of Bioven, Manufactured by Biopharma Plasma, LLC, in Complex Therapy of Patients With Pneumonia Induced by COVID-19 / SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04500067
- Acronym / sponsor ID
- 2020-BV-BP
- Keywords
- Pneumonia, COVID-19, SARS-CoV-2, IVIG, Immunoglobulin for Intravenous Administration, Bioven, Coronavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Biopharma Plasma LLCIndustry (pharma, biotech, devices)
- Collaborators
- Lviv National Medical University, Vinnitsa National Medical University
- Study start
- 7 May 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 5 Aug 2020 (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.
Pneumonia caused by coronavirus infection COVID-19 is characterized by a combination of several dangerous factors that consistently worsen the patient's condition: viral lung damage early in the disease; a sharp increase in inflammation on the background of an unbalanced immune response ("cytokine storm"); joining a bacterial infection.
The condition of patients deteriorates significantly mostly at cytokine storm development. The damaging of a large volume of lung tissue leads to develops of respiratory failure, respiratory distress syndrome, or shock. Ventilatory support becomes ineffective and patients die.
There are reports of the effectiveness of Human Normal Immunoglobulin for Intravenous Administration (IVIG) high doses when used as part of complex therapy in patients with pneumonia caused by coronavirus COVID-19. In particular, IVIG has a positive effect on survival rates, overall disease course, duration of stay in the intensive care unit, and ventilatory support duration.
The probable mechanism of action of high-dose IVIG therapy is considered to be a regulatory effect on the immune system. Similar is the known and confirmed effectiveness of IVIG for autoimmune diseases (Kavasaky disease, Guillain Barre syndrome, Chronic inflammatory demyelinating polyradiculoneuropathy, Multifocal motor neuropathy).
This trial to assesses the Efficacy of IVIG (medication trade name - Bioven, manufactured by Biopharma Plasma LLC) in the High Immunomodulatory Dose in Complex Treatment of Severe Pneumonia Caused by COVID-19 / SARS-CoV-2
Detailed description
The screening stage:
The patient or his legal representative must sign an informed consent. After signing the informed consent, the screening tests\&procedures are performed and the compliance with the inclusion / non-inclusion criteria is assessed.
For patients who have been screened and meet the inclusion criteria and do not fall under the exclusion criteria, a blinded randomization procedure is provided.
Randomization is performed by the IVRS method, according to the blinded-block patient's randomization table.
The clinical stage of the trial:
Begins after patient randomization. At the clinical stage, among other things, provides:
- Determination of the individual dose of the study drug (in the study group)
- Administration of the drug (in the study group)
- Registration of adverse events
- registration of information about taking antiviral drugs for the treatment of COVID-19;
- registration of information on symptomatic therapy and administration of drugs for the treatment of comorbidities;
- measurement of vital signs (blood pressure, heart rate, respiratory rate, body temperature);
- Determination of SPO2 level
- Determining the need for ventilation
- Determining the need for intensive care
- Assessment of compliance with the exclusion criteria
Patients in the Control Group will receive therapy recommended by the COVID-19 coronavirus infection treatment protocol, depending on the severity of their condition according to the prescribing list, which will not include immunoglobulin preparations.
Patients of the Study Group (IVIG) receive high-dose therapy with the study drug (Bioven, 10% solution for infusions produced by Biopharma Plasma LLC, Ukraine). The dose is calculated by body weight. Patients will also receive therapy recommended by the COVID-19 coronavirus infection treatment protocol, depending on the severity of their condition according to the prescribing list.
Bioven administered intravenously, at an initial rate of 0.5 - 1.0 ml/kg body weight/hour for 30 minutes. In the absence of any undesirable side effects, the rate of administration can be gradually increased (recommended increase by 0.5 - 1.5 ml/kg body weight/hour every 10 minutes). According to results previously accomplished clinical studies, the maximum rate of Bioven administration is up to 8.5 ml/kg body weight/hour.
Observation and completion stage:
Begins and continues from the last administration of the study drug until the discharge of the patient from the hospital, but not less than 28 days from the confirmation of the diagnosis of pneumonia caused by coronavirus infection COVID-19.
The following procedures are provided at the stage:
- registration of information about taking antiviral drugs for the treatment of COVID-19;
- registration of information on symptomatic therapy and administration of drugs for the treatment of comorbidities;
- measurement of vital signs (blood pressure, heart rate, respiratory rate, body temperature);
- determination of SPO2 level
- registration of the results of the examination of the lungs by computed tomography (or radiography)
- taking biomaterials for laboratory research:
- general blood test (erythrocytes, hemoglobin, expanded leukocyte formula, platelets, etc.);
- general analysis of urine;
- biochemical analysis of blood;
- state of the coagulation system
- determination of inflammatory factors in the dynamics (CRP, ferritin, procalcitonin; TNF-α), IL-1-beta, IL-6, complement component C3 (C3), circulating immune complexes (CIC), etc.),
- determination of IgG subclasses (G1, G2, G3, G4,);
- Determining the need for ventilation
- Determining the need for intensive care
- Adverse reactions registration
- Assessment of compliance with the exclusion criteria
The patient's condition is assessed daily till discharge; and by schedule after discharge (if it happen earlier), during 28 days period after diagnosis of severe pneumonia caused by coronavirus infection COVID-19 In case of death of the patient - the date and cause of death are fixed. The results of the study are evaluated by endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label multicenter randomized controlled in parallel groups. Patients undergoing screening are randomized into groups in equal proportions: * Study Group (receive IVIG Bioven with base therapy). * Control group (receive base therapy only) At the stage of Data Analysis to ensure comparability of data and homogeneity of the sample, the possibility of additional comparison of groups based on the actually prescribed base therapy and other identified covariates is provided.
| Arm | Type | Receives |
|---|---|---|
| Study Group (IVIG) | Experimental | Drug: IVIGPatients receive IVIG (trade name - Bioven) with base therapy |
| Control group | No intervention | –Patients receive base therapy only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Men and women 18 years of age and older;
- COVID-19 documentary confirmed by PCR lab test;
- severe pneumonia caused by COVID-19 according to the criteria below:
- the signed patient's informed consent to participation in the trial;
- the negative pregnancy test (for female patients of reproductive age), readiness to use reliable contraception methods during the whole duration of the trial.
Key exclusion criteria (15 listed)
- known intolerance to plasma or immunoglobulin drugs;
- drug allergy or hypersensitization to immunoglobulin drugs;
- any known counter-indication to immunoglobulin drugs according to the instruction for medical application of the tested drug;
- pneumonia not associated with COVID-19 infection;
- pregnancy, lactation period;
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 |
|---|---|---|
| IVIGAlso: Human normal immunoglobulin for intravenous administration, BiovenPatients in the study group receive the drug Bioven, 10% solution for infusions produced by LLC Biopharma Plasma 0,8-1,0 g/kg once a day for 2 days (total course dose - 1.6-2.0 g/kg) as well as base treatment recommended by the protocol of COVID-19 coronavirus infection treatment depending on the severity of their condition according to the prescription sheet. | Drug | Study Group (IVIG) |
Primary outcome
Period duration (in days) to clinical improvement
Time frame: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days
Number of days post-onset of severe pneumonia to the moment of normalization at least two from following primary outcomes: O2 saturation with self-breathing, respiratory movements rate with self-breathing, body temperature without antipyretics use, lymphocyte count (targeted levels set in the description each of these primary outcomes)
O2 saturation (SPO2 percentage), with self-breathing
Time frame: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days
The target level of SPO2 percentage - 95% and above with self-breathing, is used as one of the clinical improvement criteria
Respiratory movements rate (amount per minute), with self-breathing
Time frame: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days
The target level of respiratory movements - 28 per minute or less with self-breathing, is used as one of the clinical improvement criteria
Body temperature without antipyretics use
Time frame: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days
Measured in degrees Celsius. Fever absence (body temperature no more 37 degrees Celsius) during at least 24 hours without antipyretics, is used as one of the clinical improvement criteria.
Lymphocyte count
Time frame: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days
The target level 1000 cells / mm3 and above is used as one of the clinical improvement criteria (applicable for patients with lymphocytes count lower 1000 cells / mm3 at screening moment)
15 secondary outcomes
Time from the onset of the disease to discharge, in days
Time frame: 28 days
Duration of the need for ventilatory support, in days
Time frame: 28 days
Duration of the need for intensive care, in days
Time frame: 28 days
Duration of need for oxygenation in days (SPO2 ≤ 93% with self-breathing)
Time frame: 28 days
The C-reactive protein (CRP) level
Time frame: Day 0 (screening), day 5, day 14, day 28
The tumor necrozis factor alpha (TNF-α) level
Time frame: Day 0 (screening), day 5, day 14, day 28
The interleukin-1β (IL-1β) level
Time frame: Day 0 (screening), day 5, day 14, day 28
The interleukin-6 (IL-6) level
Time frame: Day 0 (screening), day 5, day 14, day 28
The D-dimer level
Time frame: Day 0 (screening), day 5, day 14, day 28
The Complement (C3 component) level
Time frame: Day 0 (screening), day 5, day 14, day 28
The Circulating immune complexes level
Time frame: Day 0 (screening), day 5, day 14, day 28
The ferritin level
Time frame: Day 0 (screening), day 5, day 14, day 28
The procalcitonin level
Time frame: Day 0 (screening), day 5, day 14, day 28
IgG subtypes
Time frame: Day 0 (screening), day 5, day 14, day 28
Survival assessment for a 28-day follow-up period since the onset of severe pneumonia
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Yes. After completion of the trial, results will be published. Access to parts CSR planned after the release of scientific publications
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IVIG in people with Covid19 and Pneumonia, run by Biopharma Plasma LLC at 9 sites in Ukraine.
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 16 inclusion and 15 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: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Ukraine. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Period duration (in days) to clinical improvement (time frame: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days). The study lists 5 primary outcomes in all. 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 Oct 2020.