Clinical trial NCT04323332: Traditional Chinese Medicine for Severe COVID-19
Official title: A Retrospective Cohort Study to Evaluate the Efficacy and Safety of Traditional Chinese Medicine as an Adjuvant Treatment for Patients With Severe COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19
Keywords: COVID-19
Traditional Chinese Medicine
Pneumonia
Coronavirus
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 50
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Length of hospital stay (days)
timeFrame: First treatment date up to 3 months
Secondary outcomes:
measure: Duration (days) of supplemental oxygenation
timeFrame: First treatment date up to 3 months
measure: CT imaging changes
timeFrame: First treatment date up to 3 months
measure: Mortality rate
timeFrame: First treatment date up to 3 months
measure: Time to Clinical Improvement (TTCI)
timeFrame: First treatment date up to 3 months
measure: The pneumonia severity index scores
timeFrame: First treatment date up to 3 months
measure: Time to COVID-19 nucleic acid testing negativity in throat swab
timeFrame: First treatment date up to 3 months
measure: Blood immune cell count
timeFrame: Baseline, 7 and/ or 14 days
measure: Serum inflammatory markers
timeFrame: Baseline, 7 and/ or 14 days
measure: Erythrocyte sedimentation rate
timeFrame: Baseline, 7 and/ or 14 days
measure: Platelet and D-dimer changes
timeFrame: Baseline, 7 and/ or 14 days
measure: Creatinine changes
timeFrame: Baseline, 7 and/ or 14 days
measure: Muscle enzymes changes
timeFrame: Baseline, 7 and/ or 14 days
measure: Usage of antibiotics
timeFrame: First treatment date up to 3 months
measure: Usage of glucocorticoids
timeFrame: First treatment date up to 3 months
measure: Frequency of adverse events
timeFrame: First treatment date up to 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Hao Li
state: Beijing
Study officials:
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Hao Li, Professor
role: STUDY_CHAIR
References: