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Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe)

3. mars 2020 oppdatert av: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay.

In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Xiyanping injection has anti-inflammatory and immune regulation effects. This study is a Randomized, Parallel Controlled Clinical Study to treat patients with COVID-19 infection.

Studieoversikt

Detaljert beskrivelse

The new coronavirus (COVID-19) [1] belongs to the new beta coronavirus. Current research shows that it has 85% homology with bat SARS-like coronavirus (bat-SL-CoVZC45), but its genetic characteristics are similar to SARSr-CoV. There is a clear difference from MERSr-COV. Since December 2019, Wuhan City, Hubei Province has successively found multiple cases of patients with pneumonia infected by a new type of coronavirus. With the spread of the epidemic, as of 12:00 on February 12, 2020, a total of 44726 confirmed cases nationwide (Hubei Province) 33,366 cases, accounting for 74.6%), with 1,114 deaths (1068 cases in Hubei Province), and a mortality rate of 2.49% (3.20% in Hubei Province).

In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Xiyanping injection has anti-inflammatory and immune regulation effects. In the early clinical practice of treating severe H1N1, it was clinically concerned, and combined with conventional treatment, and achieved good results.

Studietype

Intervensjonell

Registrering (Forventet)

80

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 100 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Aged >=18 years;
  2. Novel coronavirus pneumonia patients diagnosed by pathogenic testing;
  3. The patient himself participated in the study voluntarily, agreed and signed the informed consent.

Exclusion Criteria:

  1. Meet the diagnostic criteria for severe new-type coronavirus infection pneumonia;
  2. Severe primary diseases that affect survival, including: uncontrolled malignant tumors, hematological diseases, and HIV that have not been metastasized in multiple places;
  3. Obstructive pneumonia, pulmonary interstitial fibrosis, alveolar proteinosis, and allergic alveolitis caused by lung tumors;
  4. Women who are breastfeeding or pregnant;
  5. Those who are known to be allergic to the ingredients contained in the research medication, or patients with allergies;
  6. Those who have continued to use immunosuppressive agents or organ transplants in the past 6 months;
  7. Patients who have participated in other drug clinical trials within 3 months before the screening test;
  8. The investigator judges that he or she cannot complete or should not participate in the study (expected death within 48 hours, and the patient refuses active treatment)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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: Experimental group of ordinary COVID-19
Lopinavir / ritonavir tablets combined with Xiyanping injection
Xiyanping injection, 10-20ml daily, Qd, the maximum daily does not exceed 500mg (20mL) + Lopinavir tablet or Ritonavir tablet+Alpha-interferon nebulization, for 7-14 days,
Aktiv komparator: Control group of ordinary COVID-19
ritonavir/ritonavir treatment
Lopinavir / ritonavir tablets, 2 times a day, 2 tablets at a time; alpha-interferon nebulization
Eksperimentell: Experimental group of severe COVID-19
Lopinavir / ritonavir tablets combined with Xiyanping injection
Xiyanping injection, 10-20ml daily, Qd, the maximum daily does not exceed 500mg (20mL) + Lopinavir tablet or Ritonavir tablet+Alpha-interferon nebulization, for 7-14 days,

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical recovery time
Tidsramme: Up to Day 28
The time from study drug use to complete fever reduction and cough recovery is measured in hours.
Up to Day 28

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

14. mars 2020

Primær fullføring (Forventet)

14. juli 2020

Studiet fullført (Forventet)

14. april 2021

Datoer for studieregistrering

Først innsendt

3. mars 2020

Først innsendt som oppfylte QC-kriteriene

3. mars 2020

Først lagt ut (Faktiske)

4. mars 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. mars 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. mars 2020

Sist bekreftet

1. mars 2020

Mer informasjon

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

Kliniske studier på Lopinavir / ritonavir tablets combined with Xiyanping injection

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