Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    aprotinin | covid-19
Previous Study | Return to List | Next Study

An Open Non-comparative Study of the Efficacy and Safety of Aprotinin in Patients Hospitalized With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04527133
Recruitment Status : Active, not recruiting
First Posted : August 26, 2020
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
Aviron LLC

Brief 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. 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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Aprotinin Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: A non-comparative study of the efficacy and safety
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Non-comparative Study of the Efficacy and Safety of Aprotinin in Patients Hospitalized With COVID-19
Actual Study Start Date : June 11, 2020
Actual Primary Completion Date : August 11, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Aprotinin

Arm Intervention/treatment
Experimental: Stage 1/Group 1
Intravenous Aprotinin in addition to standard care: 1 000 000 KIU IV daily during 3 days
Drug: Aprotinin
Intravenous or inhalation
Other Name: Gordox®

Experimental: Stage 2/Group 2
Inhaled Aprotinin in addition to standard care: 625 KIU 4 times per day during 5 days
Drug: Aprotinin
Intravenous or inhalation
Other Name: Gordox®

Experimental: Stage 2/Group 3
Intravenous Aprotinin in addition to standard care that includes Favipiravir: 1 000 000 KIU IV daily during 5 days
Drug: Aprotinin
Intravenous or inhalation
Other Name: Gordox®




Primary Outcome Measures :
  1. 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]

  2. Time to CRP normalization [ Time Frame: 10 days ]
    Time to CRP <10 mg/L [days]

  3. Time to D-dimer normalization [ Time Frame: 10 days ]
    Time to D-dimer <243 ng/mL [days]


Secondary Outcome Measures :
  1. Time to body temperature normalization [ Time Frame: 14 days ]
    Time to body temperature <37oC [days]

  2. Change in absolute neutrophil count (ANC) [ Time Frame: Baseline to Day 14 ]
    Change of ANC [cells/L]

  3. Change in white blood cells (WBC) [ Time Frame: Baseline to Day 14 ]
    Change of WBC [cells/L]

  4. Change of CRP [ Time Frame: Baseline to Day 14 ]
    Change of CRP [mg/L]

  5. Change of D-dimer [ Time Frame: Baseline to Day 14 ]
    Change of D-dimer [ng/mL]

  6. Change in fibrinogen [ Time Frame: Baseline to Day 14 ]
    Change of fibrinogen [g/L]

  7. Change of Quick's value [ Time Frame: Baseline to Day 14 ]
    Change of Quick's value [%]

  8. Change of international normalized ratio (INR) [ Time Frame: Baseline to Day 14 ]
    Change of INR [score]

  9. Changes of lung injury on CT scan [ Time Frame: Baseline to Day 14 ]
    Improvement, no change or worsening of the lung injury on CT scan [proportion of patients]

  10. 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 clinical status improvement by 2 scores in accordance with the WHO-OSCI or discharge from the hospital [proportion of patients]

  11. Frequency of deterioration of the patients' status [ Time Frame: 14 days ]
    Frequency of transfer to the ICU, non-invasive ventilation, invasive ventilation and mortality rate [proportion of patients]

  12. Frequency of AEs and SAEs [ Time Frame: 14 days ]
    Frequency of AEs and SAEs of various severity according to subjective complains, physical examination, vital signs, laboratory tests and ECG [% of patients]



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed Patient Information Sheet and Informed Consent Form for participation in the study;
  2. Adult male or female ≥18 years of age;
  3. Body mass < 90 kg;
  4. Positive qualitative RNA SARS-CoV-2 PCR analysis at screening;
  5. Score 4 on the WHO-OSCI (added at Stage 2);
  6. Subjects with moderate-to-severe disease with the follow conditions and symptoms:

    • Pneumonia;
    • Fever > 38°C;
    • Blood serum CRP > 10 mg/L.
  7. Agreement to use medically acceptable forms of birth control during the study (contraceptive with spermicide).

Exclusion Criteria:

  1. 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;
    • Septic shock.
  2. Chronic liver and kidney diseases in terminal stage;
  3. Other organs failure requiring control and treatment in the ICU;
  4. Subjects with HIV;
  5. Using of Aprotinin during 6 months prior to screening; hypersensitivity to any of the drug components;
  6. Participation in any other clinical trial or using of other study drugs during 28 days prior to screening;
  7. 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;
  8. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527133


Locations
Layout table for location information
Russian Federation
Regional State Budgetary Healthcare Institution "Clinical Hospital №1"
Smolensk, Russian Federation
Sponsors and Collaborators
Aviron LLC
Investigators
Layout table for investigator information
Principal Investigator: Elena Simakina, MD Clinical Hospital #1, Smolensk
Layout table for additonal information
Responsible Party: Aviron LLC
ClinicalTrials.gov Identifier: NCT04527133    
Other Study ID Numbers: COVID-APR-01
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: not planned

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aviron LLC:
COVID-19
SARS-CoV-2
pneumonia
inpatients
Additional relevant MeSH terms:
Layout table for MeSH terms
Aprotinin
Hemostatics
Coagulants
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action