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

NCT04527133 | Unknown

• 1 other identifier: COVID-APR-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2; pneumonia; inpatients

Outcome Measures

Primary Outcomes (3)

• Time to elimination of SARS-CoV-2 virus

  Time to two negative PCR tests with at least 24 hours interval \[days\]

  10 days

• Time to CRP normalization

  Time to CRP \<10 mg/L \[days\]

  10 days

• Time to D-dimer normalization

  Time to D-dimer \<243 ng/mL \[days\]

  10 days

Secondary Outcomes (12)

• Time to body temperature normalization

  14 days

• Change in absolute neutrophil count (ANC)

  Baseline to Day 14

• Change in white blood cells (WBC)

  Baseline to Day 14

• Change of CRP

  Baseline to Day 14

• Change of D-dimer

  Baseline to Day 14

Study Arms (3)

Stage 1/Group 1

EXPERIMENTAL

Intravenous Aprotinin in addition to standard care: 1 000 000 KIU IV daily during 3 days

Drug: Aprotinin

Stage 2/Group 2

EXPERIMENTAL

Inhaled Aprotinin in addition to standard care: 625 KIU 4 times per day during 5 days

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

Drug: Aprotinin

Interventions

Aprotinin DRUG

Intravenous or inhalation

Also known as: Gordox®

Stage 1/Group 1; Stage 2/Group 2; Stage 2/Group 3

Eligibility Criteria

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

You may qualify if:

• 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:
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Aviron LLC: lead

Study Sites (1)

Regional State Budgetary Healthcare Institution "Clinical Hospital №1"

Smolensk, Russia

Location

MeSH Terms

Conditions

COVID-19; Pneumonia

Interventions

Aprotinin; gordox

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Elena Simakina, MD

  Clinical Hospital #1, Smolensk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A non-comparative study of the efficacy and safety

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 26, 2020
• Study Start: June 11, 2020
• Primary Completion: August 11, 2020
• Study Completion: August 31, 2020
• Last Updated: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)