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The primary objective of this study is to investigate the efficacy of Ingavirin®, 90 mg capsules in achieving clinical improvement of novel coronavirus disease (COVID-19) symptoms. A secondary goal of this study is to evaluate the safety of Ingavirin®, 90 mg capsules in patients with COVID-19 infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ingavirin®, 90 mg capsules | Experimental | Ingavirin®, 90 mg capsules will be administered on top of standard therapy: days 1-3: 180 mg (2 capsules once a day); days 4-7: 90 mg (1 capsule 1 time per day). |
|
| Placebo | Placebo Comparator | Placebo capsules will be administered on top of standard therapy: days 1-3: 2 capsules once a day; days 4-7: 1 capsule 1 time per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingavirin®, 90 mg capsules | Drug | 90-180 mg/day for 7 days on top of standard therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical recovery | Time (in hours from first dose) to clinical recovery as assessed by Hazard Ratio analysis. Clinical recovery refers to a score of ≤1 on the COVID-19 Core Symptom Rating Scale for each symptom. | Day 2-28 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of patient status | Proportion of patients with improvement of one category or more on the World Health Organization (WHO) scale by Days 2-28; proportion of patients with deterioration by one category or more on Days 2-28; average change in WHO category by Day 2-28 from baseline; proportion of patients with progression to WHO category 3 or higher by Day 14. | Day 2-28 |
| Measure | Description | Time Frame |
|---|---|---|
| Status assessment | Percentage of patients hospitalized during the study; length of hospitalization; proportion of patients transferred to the ICU during hospitalization; length of stay in the ICU; proportion of patients with acute respiratory distress syndrome during hospitalization; presence of fatal outcome. | Day 2-28 |
Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Municipal Budgetary Institution of Healthcare "Central City Hospital of Novoshakhtinsk" | Novoshakhtinsk | Rostov Oblast | 346918 | Russia | ||
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C539419 | pentanedioic acid imidazolyl ethanamide |
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| Placebo | Drug | 1-2 capsules for 7 days on top of standard therapy |
|
| Assessment of clinical measures | Proportion of patients with oxygen saturation (SpO2) ≤ 93%; proportion of patients with SpO2 ˂ 95%; average change in SpO2 compared to baseline; proportion of patients with respiratory rate (RR) > 30/min; proportion of patients with RR > 22/min; proportion of patients with RR ≤ 20/min; average change in RR; proportion of patients with fever ≤ 37.0°C; proportion of patients with fever ≤ 37.5°C; proportion of patients with temperatures ≥38.5°C; mean change in temperature from baseline. | Day 2-28 |
| Symptom Score | Proportion of patients with a score ≤ 1 on the Daytime and Nighttime Cough Scale; average change in cough scale score from baseline; mean time to reach ≤ 1 score on the cough scale; percentage of patients with a decrease of 1 point or more on each symptom on the COVID-19 symptom scale; percentage of patients with clinical improvement (1 point or less) on each symptom on the COVID-19 symptom scale; percentage of patients with a score ≤ 1 on each symptom on the COVID-19 symptom scale; average change in score for each symptom on the COVID-19 symptom scale from baseline; average time to reach a score ≤ 1 on each symptom on the COVID-19 symptom scale. | Day 2-28 |
| Evaluation of laboratory and instrumental examinations | Percentage of patients negative for Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) by Day 4, 8, 14, 21, 28 (if positive on previous examination); mean change in SARS-CoV-2 concentration by Day 8; time to SARS-CoV-2 elimination. | Day 2-28 |
| Assessment of respiratory support |
Percentage of patients needing oxygen therapy; percentage of patients needing high-flow oxygen therapy; percentage of patients needing noninvasive ventilation; percentage of patients needing invasive ventilation; percentage of patients needing extracorporeal membrane oxygenation (ECMO); total duration of oxygen therapy by the last day of hospitalization; total duration of high-flow oxygen therapy by the last day of hospitalization; total duration of noninvasive ventilation by the last day of hospitalization; total duration of invasive ventilation by the last day of hospitalization; cumulative duration of ECMO by the last day of hospitalization. |
| Day 2-28 |
| X-Ray evaluation | Proportion of patients with CT-1 or higher (CT-2, CT-3, and CT-4) according to lung CT data; proportion of patients with CT-0. | Day 2-28 |
| Safety assessment | Number and incidence of adverse events (AEs) reported during the study after study drug use and characteristics of AEs (intensity, severity, frequency, severity, expectancy, association with study therapy); number and frequency of serious adverse events (SAEs) reported during the study after the use of the study drug, and characteristics of SAEs (intensity, severity, frequency, severity, expectancy, association with the study therapy). | Day 2-28 |
| "4D Ultrasound Clinic" LLC |
| Pyatigorsk |
| Stavropol Kray |
| 357502 |
| Russia |
| Ivanovo Kuvaev Clinical Hospital | Ivanovo | 153025 | Russia |
| State Budgetary Institution of Healthcare of Moscow "City Polyclinic No. 2 of the Moscow Department of Healthcare" | Moscow | 117556 | Russia |
| Unimed-C Jsc | Moscow | 119571 | Russia |
| Ryazan State Medical University named after Academician I.P. Pavlova | Ryazan | 390026 | Russia |
| State Budgetary Institution of the Ryazan Region "Regional Clinical Hospital" | Ryazan | 390039 | Russia |
| Limited Liability Company "Medical Center "Capital-Policy" | Saint Petersburg | 190013 | Russia |
| Saint Petersburg State Budgetary Healthcare Institution "City polyclinic No. 112" | Saint Petersburg | 195427 | Russia |
| Limited Liability Company "Research Center Eco-Safety" | Saint Petersburg | 196143 | Russia |
| St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117" | Saint Petersburg | 196143 | Russia |
| Saint Petersburg State Budgetary Institution of Healthcare "City Pokrovskaya Hospital" | Saint Petersburg | 199106 | Russia |
| Astarta LLC | Saint Petersburg | 199226 | Russia |
| "Family Clinic" LLC | Yekaterinburg | 620102 | Russia |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |