Traditional Chinese Medicine for Severe COVID-19

• ClinicalTrials.gov Identifier: NCT04323332
• Recruitment Status: Unknown
• First Posted: March 26, 2020
• Last Update Posted: March 26, 2020
• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Information provided by (Responsible Party): Li Hao, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Tracking Information

• First Submitted Date: March 8, 2020
• First Posted Date: March 26, 2020
• Last Update Posted Date: March 26, 2020
• Estimated Study Start Date: March 2020
• Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 24, 2020): Length of hospital stay (days) [ Time Frame: First treatment date up to 3 months ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 24, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: COVID-19

Intervention

Drug: 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.

Study Arms

• Experimental: Traditional Chinese Medicine
  TCM prescription and conventional treatments
  Intervention: Drug: Traditional Chinese Medicine Prescription
• No Intervention: Control
  conventional treatments

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 24, 2020): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2020
• Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 85 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04323332
• Other Study ID Numbers: 2020XLA015-1
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol

• Current Responsible Party: Li Hao, Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Hao Li, Professor; Xiyuan Hospital of China Academy of Chinese Medical Sciences

• PRS Account: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Verification Date: March 2020