- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05184127
Evaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Moderate COVID-19
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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:
- standard therapy which included symptomatic treatment as well as etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b.
- 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.
- 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
-
Moscow, Den russiske føderasjonen, 115478
- NRC Institute of Immunology FMBA
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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%.
- Able to give informed consent and attend all study visits
- Positive PCR-test for COVID-19 ≤72 hours prior to randomization
- The patient's ability to inhale the experimental drug
- Participants must agree to use the reliable contraception while on study medication and for posttrial contraception for 3 month
Key Exclusion Criteria:
- Fever > 38.5°C.
- Cough severity is less than 1 point on a 4-point scale.
- Respiratory rate > is more than 30 / min
- SpO2 ≤ 93%.
- Decreased level of consciousness, agitation.
- Unstable hemodynamics (systolic blood pressure less than 100 mmHg or diastolic blood pressure less than 60 mmHg).
- The need to require mechanical ventilation beyond the screening/ randomization.
- Long-term systemic corticosteroid exposure.
- Autoimmune or inflammatory diseases (systemic / localized).
- Positive blood tests for HIV, hepatitis B and С, syphilis.
- Pregnancy and breast-feeding
- Previous adverse reactions to the active substance and/or excipients included in the drug.
- Any use of anti-viral medications or immunomodulatory agents up to 7 days before participating in the study
- Chronic diseases of the cardiovascular system
- Type 1 diabetes
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);
- Treatment with any medicine that have a pronounced effects on the blood coagulation system (expect for COVID-19 treatment), including combined oral contraceptives.
- Treatment with any medicine that can affect cardiac conduction
- Participation in other investigational drug or device clinical trials within 90 days prior to screening.
- History of alcohol, drug or chemical abuse.
- Mental illness.
- 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.
- Any conditions that, according to the researcher's, may be a contraindication to the participation in the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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
|
Drug contains anti-SARS-CoV-2 siRNAs/KK-46 (peptide dendrimer) complexes for inhalation use.
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
|
Aktiv komparator: 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.
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Relief of fever
Tidsramme: Within 14 days
|
Reduction in axillary temperature below 37 °C without antipyretic drugs use
|
Within 14 days
|
Respiratory rate
Tidsramme: Within 14 days
|
Respiratory rate ≤ 22 per minute
|
Within 14 days
|
Oxygen saturation
Tidsramme: Within 14 days
|
SpO2 > 94%
|
Within 14 days
|
Severity of cough
Tidsramme: Within 14 days
|
Severity in a patient's cough no more than 1 point on a four-point scale
|
Within 14 days
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SiCoV/KK46- 2021_CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Covid-19
-
Yang I. PachankisAktiv, ikke rekrutterendeCOVID-19 luftveisinfeksjon | COVID-19 stresssyndrom | Covid-19-vaksinebivirkning | COVID-19-assosiert tromboembolisme | COVID-19 Post-Intensive Care Syndrome | COVID-19-assosiert hjerneslagKina
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico og andre samarbeidspartnereFullførtPostakutte følgetilstander av COVID-19 | Tilstand etter covid-19 | Langvarig COVID | Kronisk COVID-19 syndromItalia
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRekrutteringCovid-19-pandemi | Covid-19-vaksiner | COVID-19 virussykdomIndonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkHar ikke rekruttert ennåPost-COVID-19 syndrom | Lang COVID | Lang Covid19 | Tilstand etter covid-19 | Post-COVID syndrom | Tilstand etter COVID-19, uspesifisert | Tilstand etter COVIDNederland
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyFullførtPost-COVID-19 syndrom | Long-COVID-19 syndromTyskland
-
Indonesia UniversityRekrutteringPost-COVID-19 syndrom | Lang COVID | Tilstand etter covid-19 | Post-COVID syndrom | Lang COVID-19Indonesia
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRekrutteringCOVID-19 lungebetennelse | COVID-19 luftveisinfeksjon | Covid-19-pandemi | COVID-19 akutt respiratorisk distress-syndrom | COVID-19-assosiert lungebetennelse | COVID 19 assosiert koagulopati | COVID-19 (Coronavirus Disease 2019) | COVID-19-assosiert tromboembolismeHellas
-
Endourage, LLCRekrutteringLang COVID | Lang Covid19 | Post-akutt COVID-19 | Langdistanse COVID | Langdistanse COVID-19 | Postakutt covid-19 syndromForente stater
-
First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital og andre samarbeidspartnereRekrutteringKohortoppfølging av epidemi og nevroimaging for pasienter under den første bølgen av COVID-19 i KinaCovid-19 | Post-COVID-19 syndrom | Post-akutt COVID-19 | Akutt COVID-19Kina
Kliniske studier på MIR 19 ®
-
National Research Center - Institute of Immunology...FullførtCovid-19Den russiske føderasjonen
-
Washington University School of MedicineAvsluttetPreoperativ og postoperativ incentivspirometri hos pasienter som gjennomgår større abdominal kirurgiAbdominal kirurgiForente stater
-
Chang Gung Memorial HospitalUkjentStivhet i skulderen, ikke klassifisert andre stederTaiwan
-
miR Scientific LLCAktiv, ikke rekrutterende
-
Islamia University of BahawalpurGerman University in CairoFullført
-
Medtronic CardiovascularAvsluttet
-
Miltenyi Biomedicine GmbHCity of Hope Comprehensive Cancer CenterHar ikke rekruttert ennåHematologiske maligniteter
-
NanomixFullført
-
Terumo BCTbioBiomedical Advanced Research and Development AuthorityAvsluttetHematologiske maligniteter | Hypoproliferativ trombocytopeniForente stater
-
Research Institute for Biological Safety ProblemsCity polyclinic No. 4 of the of Almaty Ministry of Healthcare of the... og andre samarbeidspartnereFullførtCovid-19 | Vaksinebivirkning | SARS-CoV-infeksjonKasakhstan