- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04323332
Traditional Chinese Medicine for Severe COVID-19
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
Beijing
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Beijing, Beijing, Chine, 100091
- Hao Li
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Key Inclusion Criteria:
- Patients were diagnosed as severe COVID-19 according to the Coronavirus disease (COVID-19) Treatment Guidance (Six edition)
- Patients received a combined treatment of TCM and conventional therapy, or only conventional therapy.
Key Exclusion Criteria:
- Age >85 years
- After cardiopulmonary resuscitation
- 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.
- Respiratory failure and need mechanical ventilation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Traditional Chinese Medicine
TCM prescription and conventional treatments
|
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.
|
Aucune intervention: Control
conventional treatments
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Length of hospital stay (days)
Délai: First treatment date up to 3 months
|
First treatment date up to 3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Duration (days) of supplemental oxygenation
Délai: First treatment date up to 3 months
|
First treatment date up to 3 months
|
|
CT imaging changes
Délai: First treatment date up to 3 months
|
First treatment date up to 3 months
|
|
Mortality rate
Délai: First treatment date up to 3 months
|
First treatment date up to 3 months
|
|
Time to Clinical Improvement (TTCI)
Délai: First treatment date up to 3 months
|
First treatment date up to 3 months
|
|
The pneumonia severity index scores
Délai: 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
Délai: First treatment date up to 3 months
|
First treatment date up to 3 months
|
|
Blood immune cell count
Délai: 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
Délai: 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
Délai: Baseline, 7 and/ or 14 days
|
Changes in erythrocyte sedimentation rate from baseline.
|
Baseline, 7 and/ or 14 days
|
Platelet and D-dimer changes
Délai: Baseline, 7 and/ or 14 days
|
Changes in platelets and D-dimers from baseline.
|
Baseline, 7 and/ or 14 days
|
Creatinine changes
Délai: Baseline, 7 and/ or 14 days
|
Changes in serum creatinine from baseline.
|
Baseline, 7 and/ or 14 days
|
Muscle enzymes changes
Délai: 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
Délai: First treatment date up to 3 months
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Dosing time and amounts of antibiotics;the categories of the antibiotics
|
First treatment date up to 3 months
|
Usage of glucocorticoids
Délai: First treatment date up to 3 months
|
Dosing time and amounts of glucocorticoids
|
First treatment date up to 3 months
|
Frequency of adverse events
Délai: First treatment date up to 3 months
|
First treatment date up to 3 months
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Hao Li, Professor, Xiyuan Hospital of China Academy of Chinese Medical Sciences
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2020XLA015-1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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 .
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