Efficacy and Safety of Ingavirin®, 90 mg Capsules in Patients With COVID-19

NCT05216497 | Completed Phase 3 DMC

• 1 other identifier: ING-03-05-2020
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Assessment of patient status

  Day 2-28

• Assessment of clinical measures

  Day 2-28

• Symptom Score

  Day 2-28

• Evaluation of laboratory and instrumental examinations

  Day 2-28

Other Outcomes (4)

• Status assessment

  Day 2-28

• Assessment of respiratory support

  Day 2-28

• X-Ray evaluation

  Day 2-28

Study Arms (2)

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).

Drug: Ingavirin®, 90 mg capsules

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.

Drug: Placebo

Interventions

Ingavirin®, 90 mg capsules DRUG

90-180 mg/day for 7 days on top of standard therapy

Ingavirin®, 90 mg capsules

Placebo DRUG

1-2 capsules for 7 days on top of standard therapy

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent of the patient to participate in the study.
• Patients aged 18-75 years inclusive.
• COVID-19 diagnosis based on laboratory confirmation of SARS-CoV-2 virus, conducted within 3 days prior to the first dose of the drug. Determination of SARS-CoV-2 virus by polymerase chain reaction (PCR) or other method regulated by the actual clinical recommendations is acceptable.
• Patients with a mild course of COVID-19 - presence of at least 2 criteria: SpO2 ≥ 95% (mandatory criterion), body temperature ˂ 38°C, respiratory rate (RR) ≤ 22/min.
• Duration of illness not more than 3 full days from the onset of one or more of the following symptoms until the first dose of study drug: elevated body temperature; dry cough or cough with small amount of sputum; shortness of breath; myalgia; fatigue; feeling of stuffiness in the chest; sore throat; nasal congestion/rhinorrhea; headache; feeling of heat or fever; decreased sense of smell and/or taste.
• Presence of at least two symptoms on the COVID-19 Core Symptom Rating Scale with a score of 2 or more.
• Women only: Negative pregnancy test result. The pregnancy test need not be performed on women who are not fertile: women who are menopausal (defined as not menstruating for at least two years or more) or who have had surgical sterilization (hysterectomy, bilateral oophorectomy, tubal ligation) or have a clinical diagnosis of infertility. The presence of surgical sterilization and infertility is evaluated on the patient's word or with a document confirming this condition.
• Women with preserved reproductive potential and men whose partners have preserved reproductive potential agree to abstain from sexual intercourse for the duration of the study.
• Patients who are able to understand and comply with the treatment and procedures of the study.

You may not qualify if:

• Known or suspected hypersensitivity to the active ingredient or any of the excipients of the study drug.
• Known or suspected hypersensitivity to standard therapies.
• Presence of criteria for moderate to severe disease.
• Need for hospitalization at the time of screening or randomization.
• Body temperature ˂ 37.5°C.
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
• Presence of cancer within the past 2 years, or current suspicion of cancer.
• History or current autoimmune disease.
• Pregnancy.
• Breastfeeding period.
• Presence of serious lung diseases (the list can be expanded at the discretion of the investigator): moderate-to-severe bronchial asthma, severe to very severe chronic obstructive pulmonary disease (COPD), interstitial lung disease, pulmonary hypertension, pulmonary fibrosis, lung surgeries, tuberculosis (including suspected tuberculosis based on CT scan of the lungs at screening).
• Patients with the presence of type 1 diabetes mellitus and/or decompensated type 2 diabetes mellitus.
• Heart failure, New York Heart Association (NYHA) functional class III-IV.
• Chronic liver failure stage II (decompensated) and higher.
• History of organ transplantation.

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (14)

Municipal Budgetary Institution of Healthcare "Central City Hospital of Novoshakhtinsk"

Novoshakhtinsk, Rostov Oblast, 346918, Russia

Location

"4D Ultrasound Clinic" LLC

Pyatigorsk, Stavropol Kray, 357502, Russia

Location

Ivanovo Kuvaev Clinical Hospital

Ivanovo, 153025, Russia

Location

State Budgetary Institution of Healthcare of Moscow "City Polyclinic No. 2 of the Moscow Department of Healthcare"

Moscow, 117556, Russia

Location

Unimed-C Jsc

Moscow, 119571, Russia

Location

Ryazan State Medical University named after Academician I.P. Pavlova

Ryazan, 390026, Russia

Location

State Budgetary Institution of the Ryazan Region "Regional Clinical Hospital"

Ryazan, 390039, Russia

Location

Limited Liability Company "Medical Center "Capital-Policy"

Saint Petersburg, 190013, Russia

Location

Saint Petersburg State Budgetary Healthcare Institution "City polyclinic No. 112"

Saint Petersburg, 195427, Russia

Location

Limited Liability Company "Research Center Eco-Safety"

Saint Petersburg, 196143, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"

Saint Petersburg, 196143, Russia

Location

Saint Petersburg State Budgetary Institution of Healthcare "City Pokrovskaya Hospital"

Saint Petersburg, 199106, Russia

Location

Astarta LLC

Saint Petersburg, 199226, Russia

Location

"Family Clinic" LLC

Yekaterinburg, 620102, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

pentanedioic acid imidazolyl ethanamide

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: January 31, 2022
• Study Start: October 6, 2021
• Primary Completion: January 12, 2022
• Study Completion: April 25, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

RU (14)