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Evaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Moderate COVID-19

7 janvier 2022 mis à jour par: National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia

Open Multicenter Controlled Clinical Trial to Evaluate Safety and Efficacy of Aerosolized MIR 19 ® Inhalation in Patients With Moderate COVID-19 Who Did Not Require Treatment in the Intensive Care Unit.

This is Phase 2 multi-center controlled randomized study to assess the efficacy and safety of MIR 19® via 14 days of treatment of participants with symptomatic moderate COVID-19.

The purpose of this study is to evaluate the efficacy, safety and daily dose of MIR 19 ® for the treatment of the hospitalized patients with infection caused by SARS-CoV-2 (COVID-19) who did not require treatment in the intensive care unit.

Based on preclinical data studying antiviral effect of MIR 19® in vitro and in vivo (Khaitov M.R. et all 2021), the investigators hypothesized that SARS-CoV-2 inhibition with MIR 19® could potentially reduce pulmonary inflammation, thereby improving COVID-19 patient outcomes.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This is Phase 2 multi-center controlled randomized study to assess the efficacy and safety of MIR 19 ® in male and female volunteers with symptomatic moderate COVID-19 who did not require treatment in the intensive care unit.

The MIR 19® is a complex of siRNA, targeting SARS-CoV-2 RNA-dependent RNA polymerase (RdRp) and peptide dendrimer KK-46.

This study involved 3 cohorts who received:

  1. standard therapy which included symptomatic treatment as well as etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b.
  2. 3.7 mg of the MIR 19 ® via inhalation route plus standard therapy which included symptomatic treatment, without any etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b.
  3. 11.1 mg of the MIR 19 ® via inhalation route plus standard therapy which included symptomatic treatment, without any etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b.

All subjects will undergo scheduled safety and efficacy assessments while in the clinical unit and as outpatients to the end of the follow-up period.

Type d'étude

Interventionnel

Inscription (Réel)

156

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Men or non-pregnant female aged 18 to 65 years hospitalized with moderate COVID-19 infection: body temperature > 37.5 °C; respiratory rate > 22/min; shortness of breath during physical exertion; typical coronavirus-associated chest computed tomography (CT) changes (CT1- CT2); pulse oximetry levels SpO2< 95%.
  2. Able to give informed consent and attend all study visits
  3. Positive PCR-test for COVID-19 ≤72 hours prior to randomization
  4. The patient's ability to inhale the experimental drug
  5. Participants must agree to use the reliable contraception while on study medication and for posttrial contraception for 3 month

Key Exclusion Criteria:

  1. Fever > 38.5°C.
  2. Cough severity is less than 1 point on a 4-point scale.
  3. Respiratory rate > is more than 30 / min
  4. SpO2 ≤ 93%.
  5. Decreased level of consciousness, agitation.
  6. Unstable hemodynamics (systolic blood pressure less than 100 mmHg or diastolic blood pressure less than 60 mmHg).
  7. The need to require mechanical ventilation beyond the screening/ randomization.
  8. Long-term systemic corticosteroid exposure.
  9. Autoimmune or inflammatory diseases (systemic / localized).
  10. Positive blood tests for HIV, hepatitis B and С, syphilis.
  11. Pregnancy and breast-feeding
  12. Previous adverse reactions to the active substance and/or excipients included in the drug.
  13. Any use of anti-viral medications or immunomodulatory agents up to 7 days before participating in the study
  14. Chronic diseases of the cardiovascular system
  15. Type 1 diabetes

  16. The following laboratory parameters are excluded:

    Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total and direct bilirubin >4 x upper limit of normal (ULN);

  17. Treatment with any medicine that have a pronounced effects on the blood coagulation system (expect for COVID-19 treatment), including combined oral contraceptives.
  18. Treatment with any medicine that can affect cardiac conduction
  19. Participation in other investigational drug or device clinical trials within 90 days prior to screening.
  20. History of alcohol, drug or chemical abuse.
  21. Mental illness.
  22. Receipt of plasma from a person who recovered from COVID-19 (convalescent plasma) up to 14 days before participating in the study, vaccination against SARS-CoV-2 , the need for extracorporeal membrane oxygenation.
  23. Any conditions that, according to the researcher's, may be a contraindication to the participation in the study.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: MIR 19 ®
Study participants from experimental groups, in addition to standard COVID-19 therapy, received the MIR 19 ® (2 inhalations per day with a single dose of 1.85 or 5.55 mg at intervals of 7-8 hours for 14 days).The standard therapy in this group included symptomatic treatment without use of any etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b
Médicament: MIR 19 ®
Drug contains anti-SARS-CoV-2 siRNAs/KK-46 (peptide dendrimer) complexes for inhalation use.
Produit combiné: Standard COVID-19 therapy
Therapy carried out in accordance with the current version of the temporary methodological recommendations of the Ministry of Health of the Russian Federation for the treatment of COVID-19 infection. This therapy included symptomatic treatment as well as etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b. In the experimental groups treated with MIR 19 ®, the therapy included symptomatic treatment without use of any etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b
Comparateur actif: Standard COVID-19 therapy
In the comparison group, therapy was carried out in accordance with the current version of the temporary methodological recommendations of the Ministry of Health of the Russian Federation for the treatment of COVID-19 infection.The standard therapy included symptomatic treatment as well as etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b. In the experimental groups treated with MIR 19 ®, the therapy included symptomatic treatment without use of any etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b.
Produit combiné: Standard COVID-19 therapy
Therapy carried out in accordance with the current version of the temporary methodological recommendations of the Ministry of Health of the Russian Federation for the treatment of COVID-19 infection. This therapy included symptomatic treatment as well as etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b. In the experimental groups treated with MIR 19 ®, the therapy included symptomatic treatment without use of any etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Relief of fever
Délai: Within 14 days
Reduction in axillary temperature below 37 °C without antipyretic drugs use
Within 14 days
Respiratory rate
Délai: Within 14 days
Respiratory rate ≤ 22 per minute
Within 14 days
Oxygen saturation
Délai: Within 14 days
SpO2 > 94%
Within 14 days
Severity of cough
Délai: Within 14 days
Severity in a patient's cough no more than 1 point on a four-point scale
Within 14 days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia

Collaborateurs

St. Petersburg Research Institute of Vaccines and Sera

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

27 avril 2021

Achèvement primaire (Réel)

7 septembre 2021

Achèvement de l'étude (Réel)

7 septembre 2021

Dates d'inscription aux études

Première soumission

7 janvier 2022

Première soumission répondant aux critères de contrôle qualité

7 janvier 2022

Première publication (Réel)

11 janvier 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 janvier 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 janvier 2022

Dernière vérification

1 janvier 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SiCoV/KK46- 2021_CSR

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur COVID-19 [feminine]

Essais cliniques sur MIR 19 ®

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