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COVID-19Phase 3NCT05216497

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

A Phase 3 study testing Ingavirin®, 90 mg capsules in people with COVID-19, run by Valenta Pharm JSC at 14 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
COVID-19
What is being tested?
Ingavirin®, 90 mg capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
233 participants
Where
14 sitesRussia
Study dates
6 Oct 2021to 25 Apr 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Need for renal replacement therapy at the time of inclusion
  • History of organ transplantation.
  • History of epilepsy or need for anticonvulsant therapy.
  • Major depressive disorder, anxiety, other mental disorders requiring medication correction.
  • Acute cerebral circulation disorder, stroke, or transient ischemic attack within 90 days prior to screening.
  • Taking any antiviral and/or immunomodulatory drugs after COVID-19 manifestation.
  • Use of any immunosuppressive therapy (including tocilizumab/sarilumab) within 90 days prior to randomization, or need for immunosuppressive therapy at the time of randomization.
  • Use of anticoagulation plasma for 14 days prior to screening.
  • Use of systemic glucocorticosteroids within 90 days prior to the time of randomization, or the need to prescribe systemic glucocorticosteroids at the time of randomization.
  • History of COVID-19 vaccination.
  • Use of vaccines against viral infections within 90 days prior to the time of randomization.
  • Patients taking or having taken other experimental drugs, drugs not approved in the Russian Federation, or participating or having participated in other clinical trials within 30 days prior to screening.
  • Abuse of alcohol or psychotropic drugs and other medications currently or within the last year.
  • Patients with other serious, unstable or clinically significant medical or psychological conditions that, in the opinion of the investigator, may interfere with the patient's participation in the study.
  • Withdrawal Criteria:
  • Withdrawal of consent;
  • AEs that make it impossible to participate in the study or require emergency medical care in an inpatient setting (except in cases of hospitalization related to the patient's transition to a moderate to severe course of COVID-19);
  • Serious protocol violations and refusal of the participant(s) to comply with study protocol or procedures (e.g., use of protocol-prohibited therapy);
  • Pregnancy;
  • Necessity for use of medications forbidden by the protocol.
  • Participant is lost to follow-up;
  • Death of the participant;
  • Decision of the Sponsor or Investigator.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Russia14 sites

  • Ivanovo Kuvaev Clinical Hospital

    Ivanovo, 153025

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

    Moscow, 117556

  • Unimed-C Jsc

    Moscow, 119571

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

    Novoshakhtinsk, Rostov Oblast, 346918

  • "4D Ultrasound Clinic" LLC

    Pyatigorsk, Stavropol Kray, 357502

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

    Ryazan, 390026

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

    Ryazan, 390039

  • Limited Liability Company "Medical Center "Capital-Policy"

    Saint Petersburg, 190013

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

    Saint Petersburg, 195427

  • Limited Liability Company "Research Center Eco-Safety"

    Saint Petersburg, 196143

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

    Saint Petersburg, 196143

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

    Saint Petersburg, 199106

  • Astarta LLC

    Saint Petersburg, 199226

  • "Family Clinic" LLC

    Yekaterinburg, 620102

Other trials in Russia

About this study

Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Ingavirin®, 90 mg Capsules in Patients With COVID-19

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
Being tested
Ingavirin®, 90 mg capsules, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ingavirin®, 90 mg capsulesDrug

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

  • PlaceboDrug

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

Study groups in NCT05216497
Study groupRoleWhat they receive
Ingavirin®, 90 mg capsulesExperimentalIngavirin®, 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).
Receives: Drug: Ingavirin®, 90 mg capsules
PlaceboPlacebo comparatorPlacebo 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 2-28

Secondary outcomes (4)

  1. 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.

    Measured: Day 2-28

  2. 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.

    Measured: Day 2-28

  3. 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.

    Measured: Day 2-28

  4. 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.

    Measured: Day 2-28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2022
  2. Study start6 Oct 2021
  3. Primary completion12 Jan 2022
  4. Study completion25 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05216497
Sponsor's protocol ID
ING-03-05-2020
Status last verified
Jul 2023
First submitted
28 Jan 2022
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ingavirin®, 90 mg capsules in people with COVID-19, run by Valenta Pharm JSC at 14 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to clinical recovery (time frame: Day 2-28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05216497.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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