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Traditional Chinese Medicine for Severe COVID-19

24. marts 2020 opdateret af: Li Hao, Xiyuan Hospital of China Academy of Chinese Medical Sciences

A Retrospective Cohort Study to Evaluate the Efficacy and Safety of Traditional Chinese Medicine as an Adjuvant Treatment for Patients With Severe COVID-19

In December 2019, a new type of pneumonia, COVID-2019 outbroke in Wuhan ,China, and currently the infected has been reported in more than at least 75 countries.

Patients with severe COVID-19 have rapid disease progression and high mortality rate. This may attribute to the excessive immune response caused by cytokine storm. Strategies based on anti-virus drugs and treatments against symptoms have now been employed. However, these managements can't effectively treat the lethal lung injury and uncontrolled immune responses, especially in the elderly with severe COVID-19. Traditional Chinese Medicine (TCM), which treats the disease from anther perspective, has achieved satisfactory results. National Health Commission of China released a series of policies to enhance the administration of TCM prescriptions.

This study is aimed to evaluate the efficacy and safety of Traditional Chinese Medicine as an adjuvant treatment for severe COVID-19.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

50

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100091
        • Hao Li

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 85 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Key Inclusion Criteria:

  1. Patients were diagnosed as severe COVID-19 according to the Coronavirus disease (COVID-19) Treatment Guidance (Six edition)
  2. Patients received a combined treatment of TCM and conventional therapy, or only conventional therapy.

Key Exclusion Criteria:

  1. Age >85 years
  2. After cardiopulmonary resuscitation
  3. Patients combined with other organ failure or conditions need ICU monitoring and treatment, such as severe liver disease, severe renal dysfunction, upper gastrointestinal hemorrhage, disseminated intravascular coagulation.
  4. Respiratory failure and need mechanical ventilation

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Traditional Chinese Medicine
TCM prescription and conventional treatments
Medicin: Traditional Chinese Medicine Prescription
Traditional Chinese Medicine Prescriptions have been recommended according to the Guidelines for the treatment of COVID-19 issued by National Health Commission of the PRC.
Ingen indgriben: Control
conventional treatments

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Length of hospital stay (days)
Tidsramme: First treatment date up to 3 months
First treatment date up to 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration (days) of supplemental oxygenation
Tidsramme: First treatment date up to 3 months
First treatment date up to 3 months
CT imaging changes
Tidsramme: First treatment date up to 3 months
First treatment date up to 3 months
Mortality rate
Tidsramme: First treatment date up to 3 months
First treatment date up to 3 months
Time to Clinical Improvement (TTCI)
Tidsramme: First treatment date up to 3 months
First treatment date up to 3 months
The pneumonia severity index scores
Tidsramme: First treatment date up to 3 months
The pneumonia severity index is a clinical tool helping in the risk stratification of patients with community-acquired pneumonia. It ranges from 0-395 scores and a higher score indicates higher death risk.
First treatment date up to 3 months
Time to COVID-19 nucleic acid testing negativity in throat swab
Tidsramme: First treatment date up to 3 months
First treatment date up to 3 months
Blood immune cell count
Tidsramme: Baseline, 7 and/ or 14 days
Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline
Baseline, 7 and/ or 14 days
Serum inflammatory markers
Tidsramme: Baseline, 7 and/ or 14 days
Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.
Baseline, 7 and/ or 14 days
Erythrocyte sedimentation rate
Tidsramme: Baseline, 7 and/ or 14 days
Changes in erythrocyte sedimentation rate from baseline.
Baseline, 7 and/ or 14 days
Platelet and D-dimer changes
Tidsramme: Baseline, 7 and/ or 14 days
Changes in platelets and D-dimers from baseline.
Baseline, 7 and/ or 14 days
Creatinine changes
Tidsramme: Baseline, 7 and/ or 14 days
Changes in serum creatinine from baseline.
Baseline, 7 and/ or 14 days
Muscle enzymes changes
Tidsramme: Baseline, 7 and/ or 14 days
Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Baseline, 7 and/ or 14 days
Usage of antibiotics
Tidsramme: First treatment date up to 3 months
Dosing time and amounts of antibiotics；the categories of the antibiotics
First treatment date up to 3 months
Usage of glucocorticoids
Tidsramme: First treatment date up to 3 months
Dosing time and amounts of glucocorticoids
First treatment date up to 3 months
Frequency of adverse events
Tidsramme: First treatment date up to 3 months
First treatment date up to 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Efterforskere

  • Studiestol: Hao Li, Professor, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. marts 2020

Primær færdiggørelse (Forventet)

1. marts 2020

Studieafslutning (Forventet)

1. april 2020

Datoer for studieregistrering

Først indsendt

8. marts 2020

Først indsendt, der opfyldte QC-kriterier

24. marts 2020

Først opslået (Faktiske)

26. marts 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2020XLA015-1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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