COVID-19 Clinical Trial
Official title:
An Open Non-comparative Study of the Efficacy and Safety of Aprotinin in Patients Hospitalized With COVID-19
Verified date | August 2020 |
Source | Aviron LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | August 31, 2020 |
Est. primary completion date | August 11, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 (???2/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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Regional State Budgetary Healthcare Institution "Clinical Hospital ?1" | Smolensk |
Lead Sponsor | Collaborator |
---|---|
Aviron LLC |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to elimination of SARS-CoV-2 virus | Time to two negative PCR tests with at least 24 hours interval [days] | 10 days | |
Primary | Time to CRP normalization | Time to CRP <10 mg/L [days] | 10 days | |
Primary | Time to D-dimer normalization | Time to D-dimer <243 ng/mL [days] | 10 days | |
Secondary | Time to body temperature normalization | Time to body temperature <37oC [days] | 14 days | |
Secondary | Change in absolute neutrophil count (ANC) | Change of ANC [cells/L] | Baseline to Day 14 | |
Secondary | Change in white blood cells (WBC) | Change of WBC [cells/L] | Baseline to Day 14 | |
Secondary | Change of CRP | Change of CRP [mg/L] | Baseline to Day 14 | |
Secondary | Change of D-dimer | Change of D-dimer [ng/mL] | Baseline to Day 14 | |
Secondary | Change in fibrinogen | Change of fibrinogen [g/L] | Baseline to Day 14 | |
Secondary | Change of Quick's value | Change of Quick's value [%] | Baseline to Day 14 | |
Secondary | Change of international normalized ratio (INR) | Change of INR [score] | Baseline to Day 14 | |
Secondary | Changes of lung injury on CT scan | Improvement, no change or worsening of the lung injury on CT scan [proportion of patients] | Baseline to Day 14 | |
Secondary | 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] | 14 days | |
Secondary | Frequency of deterioration of the patients' status | Frequency of transfer to the ICU, non-invasive ventilation, invasive ventilation and mortality rate [proportion of patients] | 14 days | |
Secondary | 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] | 14 days |
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