COVID-19NCT04527133
An Open Non-comparative Study of the Efficacy and Safety of Aprotinin in Patients Hospitalized With COVID-19
A study testing Aprotinin in people with COVID-19, run by Aviron LLC at 1 site in Russia.
Trial summary
The observational study will be carried out in two stages. At the first stage, the efficacy and safety of Aprotinin intravenous infusion as add-on therapy to the standard of care will be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Aprotinin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 11 Jun 2020to 31 Aug 2020
- Phase
- Interventional
- 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
- Signed Patient Information Sheet and Informed Consent Form for participation in the study;
- Adult male or female ≥18 years of age;
- Body mass < 90 kg;
- Positive qualitative RNA SARS-CoV-2 PCR analysis at screening;
- Score 4 on the WHO-OSCI (added at Stage 2);
- Subjects with moderate-to-severe disease with the follow conditions and symptoms:
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- Pneumonia;
- Fever > 38°C;
- Blood serum CRP > 10 mg/L.
- Agreement to use medically acceptable forms of birth control during the study (contraceptive with spermicide).
Who cannot join
- Severe disease with one of the follow criteria:
- Respiratory rate > 35 per minute that doesn't decrease after body temperature reducing to normal or subfebrile level;
- Saturation ≤ 93% at rest;
- Partial pressure of arterial oxygen (PaO2) < 60 mmHg;
- Oxygenation index (РаО2/FiO2) ≤ 200 mmHg;
- Partial pressure of arterial CO2 (PaCO2) > 60 mmHg;
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- Septic shock.
- Chronic liver and kidney diseases in terminal stage;
- Other organs failure requiring control and treatment in the ICU;
- Subjects with HIV;
- Using of Aprotinin during 6 months prior to screening; hypersensitivity to any of the drug components;
- Participation in any other clinical trial or using of other study drugs during 28 days prior to screening;
- Pregnant or lactating women or women planning pregnancy during the clinical study; women with child-bearing potential (including women non-sterilized surgically and in postmenopause for less than 2 years) not using medically acceptable forms of birth control;
- Inability to read or write; unwillingness to understand and follow the Protocol procedures; non-compliance with the regimen of taking medications or performing procedures that, according to the Investigator, may affect the results of the study or the safety of the patient and prevent the patient from further participation in the study; any other comorbid medical or serious mental conditions that make patient ineligible for participation in the clinical study, limits the ability to obtain informed consent, or may affect patient's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Regional State Budgetary Healthcare Institution "Clinical Hospital №1"
Smolensk
About this study
The observational study will be carried out in two stages. At the first stage, the efficacy and safety of Aprotinin intravenous infusion as add-on therapy to the standard of care will be studied. At the second stage, two groups will be included: the first group will be the inhaled Aprotinin add-on therapy, the second group will be intravenous Aprotinin in combination with Favipiravir.
Read the detailed description
Primary objective of the study is to evaluate the efficacy of Aprotinin as add-on therapy in patients hospitalized with COVID-19 using the following parameters:
- The time to elimination of SARS-CoV-2 virus until Day 10;
- The time to C-reactive protein (CRP) normalization until Day 10;
- The time to D-dimer normalization until Day 10.
Secondary objectives are to evaluate the following parameters of efficacy and safety of Aprotinin add-on therapy in patients hospitalized with COVID-19:
- The time to body temperature normalization (<37oC);
- Changes from baseline of the laboratory parameters during 14 days: hematology, CRP, coagulogram;
- Changes of lung injury on CT scan on Day 7 and Day 14 from baseline;
- Frequency of clinical status improvement by 2 scores in accordance with the WHO Ordinal scale of clinical improvement (WHO-OSCI) or discharge from the hospital before Day 14;
- Frequency of transfer to the Intensive Care Unit (ICU), frequency of the non-invasive ventilation, frequency of the invasive ventilation and mortality rate;
- Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) of various severity according to subjective complains, physical examination, vital signs, laboratory tests and ECG.
- Conditions
- COVID-19
- Being tested
- Aprotinin
- Keywords
- COVID-19, SARS-CoV-2, pneumonia, inpatients
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprotininDrug
Also called Gordox®
Intravenous or inhalation
| Study group | Role | What they receive |
|---|---|---|
| Stage 1/Group 1 | Experimental | Intravenous Aprotinin in addition to standard care: 1 000 000 KIU IV daily during 3 days Receives: Drug: Aprotinin |
| Stage 2/Group 2 | Experimental | Inhaled Aprotinin in addition to standard care: 625 KIU 4 times per day during 5 days Receives: Drug: Aprotinin |
| Stage 2/Group 3 | Experimental | Intravenous Aprotinin in addition to standard care that includes Favipiravir: 1 000 000 KIU IV daily during 5 days Receives: Drug: Aprotinin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to elimination of SARS-CoV-2 virus
Time to two negative PCR tests with at least 24 hours interval [days]
Measured: 10 days
Time to CRP normalization
Time to CRP <10 mg/L [days]
Measured: 10 days
Time to D-dimer normalization
Time to D-dimer <243 ng/mL [days]
Measured: 10 days
Secondary outcomes (12)
Time to body temperature normalization
Time to body temperature <37oC [days]
Measured: 14 days
Change in absolute neutrophil count (ANC)
Change of ANC [cells/L]
Measured: Baseline to Day 14
Change in white blood cells (WBC)
Change of WBC [cells/L]
Measured: Baseline to Day 14
Change of CRP
Change of CRP [mg/L]
Measured: Baseline to Day 14
Change of D-dimer
Change of D-dimer [ng/mL]
Measured: Baseline to Day 14
Change in fibrinogen
Change of fibrinogen [g/L]
Measured: Baseline to Day 14
Change of Quick's value
Change of Quick's value [%]
Measured: Baseline to Day 14
Change of international normalized ratio (INR)
Change of INR [score]
Measured: Baseline to Day 14
Changes of lung injury on CT scan
Improvement, no change or worsening of the lung injury on CT scan [proportion of patients]
Measured: Baseline to Day 14
Frequency of clinical status improvement by 2 scores in accordance with the WHO-OSCI or discharge from the hospital
Frequency of clinical status improvement by 2 scores in accordance with the WHO-OSCI or discharge from the hospital [proportion of patients]
Measured: 14 days
Frequency of deterioration of the patients' status
Frequency of transfer to the ICU, non-invasive ventilation, invasive ventilation and mortality rate [proportion of patients]
Measured: 14 days
Frequency of AEs and SAEs
Frequency of AEs and SAEs of various severity according to subjective complains, physical examination, vital signs, laboratory tests and ECG [% of patients]
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start11 Jun 2020
- Primary completion11 Aug 2020
- Study completion31 Aug 2020 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A non-comparative study of the efficacy and safety
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aviron LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elena Simakina, MD, Principal investigator, Clinical Hospital #1, Smolensk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527133
- Sponsor's protocol ID
- COVID-APR-01
- Status last verified
- Aug 2020
- First submitted
- 24 Aug 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not planned
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Non-comparative Study of the Efficacy and Safety of Aprotinin in Patients Hospitalized With COVID-19
- ClinicalTrials.gov ID
- NCT04527133
- Acronym / sponsor ID
- COVID-APR-01
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2, pneumonia, inpatients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aviron LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 11 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 26 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.
The observational study will be carried out in two stages. At the first stage, the efficacy and safety of Aprotinin intravenous infusion as add-on therapy to the standard of care will be studied. At the second stage, two groups will be included: the first group will be the inhaled Aprotinin add-on therapy, the second group will be intravenous Aprotinin in combination with Favipiravir.
Detailed description
Primary objective of the study is to evaluate the efficacy of Aprotinin as add-on therapy in patients hospitalized with COVID-19 using the following parameters:
- The time to elimination of SARS-CoV-2 virus until Day 10;
- The time to C-reactive protein (CRP) normalization until Day 10;
- The time to D-dimer normalization until Day 10.
Secondary objectives are to evaluate the following parameters of efficacy and safety of Aprotinin add-on therapy in patients hospitalized with COVID-19:
- The time to body temperature normalization (<37oC);
- Changes from baseline of the laboratory parameters during 14 days: hematology, CRP, coagulogram;
- Changes of lung injury on CT scan on Day 7 and Day 14 from baseline;
- Frequency of clinical status improvement by 2 scores in accordance with the WHO Ordinal scale of clinical improvement (WHO-OSCI) or discharge from the hospital before Day 14;
- Frequency of transfer to the Intensive Care Unit (ICU), frequency of the non-invasive ventilation, frequency of the invasive ventilation and mortality rate;
- Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) of various severity according to subjective complains, physical examination, vital signs, laboratory tests and ECG.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A non-comparative study of the efficacy and safety
| Arm | Type | Receives |
|---|---|---|
| Stage 1/Group 1 | Experimental | Drug: AprotininIntravenous Aprotinin in addition to standard care: 1 000 000 KIU IV daily during 3 days |
| Stage 2/Group 2 | Experimental | Drug: AprotininInhaled Aprotinin in addition to standard care: 625 KIU 4 times per day during 5 days |
| Stage 2/Group 3 | Experimental | Drug: AprotininIntravenous Aprotinin in addition to standard care that includes Favipiravir: 1 000 000 KIU IV daily during 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed Patient Information Sheet and Informed Consent Form for participation in the study;
- Adult male or female ≥18 years of age;
- Body mass < 90 kg;
- Positive qualitative RNA SARS-CoV-2 PCR analysis at screening;
- Score 4 on the WHO-OSCI (added at Stage 2);
Key exclusion criteria (14 listed)
- Severe disease with one of the follow criteria:
- Chronic liver and kidney diseases in terminal stage;
- Other organs failure requiring control and treatment in the ICU;
- Subjects with HIV;
- Using of Aprotinin during 6 months prior to screening; hypersensitivity to any of the drug components;
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 |
|---|---|---|
| AprotininAlso: Gordox®Intravenous or inhalation | Drug | Stage 1/Group 1, Stage 2/Group 2, Stage 2/Group 3 |
Primary outcome
Time to elimination of SARS-CoV-2 virus
Time frame: 10 days
Time to two negative PCR tests with at least 24 hours interval [days]
Time to CRP normalization
Time frame: 10 days
Time to CRP <10 mg/L [days]
Time to D-dimer normalization
Time frame: 10 days
Time to D-dimer <243 ng/mL [days]
12 secondary outcomes
Time to body temperature normalization
Time frame: 14 days
Change in absolute neutrophil count (ANC)
Time frame: Baseline to Day 14
Change in white blood cells (WBC)
Time frame: Baseline to Day 14
Change of CRP
Time frame: Baseline to Day 14
Change of D-dimer
Time frame: Baseline to Day 14
Change in fibrinogen
Time frame: Baseline to Day 14
Change of Quick's value
Time frame: Baseline to Day 14
Change of international normalized ratio (INR)
Time frame: Baseline to Day 14
Changes of lung injury on CT scan
Time frame: Baseline to Day 14
Frequency of clinical status improvement by 2 scores in accordance with the WHO-OSCI or discharge from the hospital
Time frame: 14 days
Frequency of deterioration of the patients' status
Time frame: 14 days
Frequency of AEs and SAEs
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Individual participant dataSharing planned: No. not planned
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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.
Elena Simakina, MD principal investigator
Clinical Hospital #1, Smolensk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aprotinin in people with COVID-19, run by Aviron LLC at 1 site 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 10 inclusion and 14 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 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
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?
Time to elimination of SARS-CoV-2 virus (time frame: 10 days). The study lists 3 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 26 Aug 2020.