Effect of Traditional Chinese Medicine of Severe COVID-19

NCT06714032 | Completed Phase 3

• 1 other identifier: TCM for Severe COVID-19
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the effect of integrated traditional Chinese and Western medicine in the treatment of Severe COVID-19. The patients were randomly divided into experimental group and control group.

Conditions

Severe COVID-19

Keywords

Traditional Chinese Medicine; Severe COVID-19

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  Proportion of patients who died of disease on day 28

  Mortality on the 28th day of treatment

Secondary Outcomes (9)

• Days without invasive mechanical ventilation

  the 28 days of the treatment phase

• invasive mechanical ventilation rate

  28 days in the treatment phase

• days of non-ICU

  28 days in the treatment phase

• time to clinical stability

  every day in the treatment.

• hospitalization time

  the 28 days of the treatment phase

Study Arms (2)

TCM plus conventional drug

EXPERIMENTAL

The experimental group will receive three type of TCM inaddition conventional drug

Drug: TCM plus conventional drug

TCM placebo plus conventional drug

PLACEBO COMPARATOR

The control group will receive three type of placebo TCM inaddition conventional drug

Drug: TCM placebo plus conventional drug

Interventions

TCM plus conventional drug DRUG

All patients were treated according to international guidelines. The Experimental group will receive TCM according to the TCM syndrome.

TCM plus conventional drug

TCM placebo plus conventional drug DRUG

All patients were treated according to international guidelines. The control group will receive TCM placebo according to the TCM syndrome.

TCM placebo plus conventional drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• accord with the diagnosis of severe/critical novel coronavirus infection;
• Age \> 18 years old;
• TCM syndrome differentiation diagnosis by the attending physician or above or two attending physicians for diagnosis and consensus;
• Sign the informed consent form.

You may not qualify if:

• Pregnant and lactating women;
• Trauma, hematological malignancies, various solid tumors and obstetric complications;
• Dementia, various mental patients and those who are unwilling to cooperate;
• The patient is expected to die within the next 24 hours;
• Combined with neuromuscular diseases affecting respiratory and motor functions;
• people who have been bedridden for a long time for various reasons;
• Clinical trial participants who are taking part in other intervention measures;
• Those who are known to be allergic to the therapeutic drugs in this study.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Study Sites (1)

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: December 3, 2024
• Study Start: January 29, 2023
• Primary Completion: November 8, 2023
• Study Completion: January 25, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-12

Locations

CN (1)