Clinical trial NCT05055427: Efficacy Evaluation of Shen Cao Gan Jiang Tang on Mild and Moderate COVID-19 Patients
Official title: Efficacy of Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang With Ginseng) on Mild and Moderate COVID-19 Patients: A Multicenter, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID-19 Respiratory Infection
Herbal Medicine
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, open-label, randomized controlled trial, we recruited patients with Covid-19 from five temporary for COVID-19 treatment in Ho Chi Minh City, Viet Nam.

The protocol was designed based on the Good Clinical Practice guidelines and The Declaration of Helsinki. Number of Participants have 150 mild COVID-19 patient and 150 moderate COVID-19 patient. In each group of mild or moderate patients, we plan to randomize in a 1:1 ratio. Subjects in the investigational group will receive Shen Cao Gan Jiang Tang in addition to the Standard of Care (SOC) for the treatment of COVID-19 based on the Vietnam Ministry of Health guideline. Subjects in the controlled group will receive the Standard of Care (SOC) for the treatment of COVID-19 based on the Vietnam Ministry of Health guideline.
Primary purpose: TREATMENT

Brief summary: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes COVID-19 (coronavirus disease 2019). Patients with COVID-19 may experience various clinical manifestations, from no symptoms to critical illness such as severe pneumonia and acute respiratory distress syndrome (ADRS). So far, there is no specific medication for COVID-19; hence, the current available treatments mostly aim at symptoms management and supportive care. From traditional medicine perspective, COVID-19 is classified as warm-disease (Wen-yi). The main points of treatment for COVID-19 in early stage based on traditional medicine perspective are strengthen the Protective Qi (Wei Qi - the body immune system), and restore the balance of Qi, which is vital biological energy to prevent the invasion of external pathogens, including the SARS-CoV-2 virus. The Shen Cao Gan Jiang Tang have including Gan Cao Gan Jiang Tang (GGT) with the addition of Ginseng. This formula is originated from Shang Han Lun (Treatise on Febrile Diseases Caused by Cold) by Zhang Zhong-jing, used to enhance the Protective Qi, treat the early stage of Febrile Diseases, This clinical trial aims to evaluate the efficacy of the Shen Cao Gan Jiang Tang on mild and moderate COVID-19 patients

Detailed description: The main objectives of this clinical trial:

1. Assess the efficacy of Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) in addition to the standard of care on reducing duration and severity of symptoms compared with the standard of care in mild and moderate COVID-19 patients.
2. Assess the efficacy of Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) in addition to the standard of care on reducing the proportion of patients progressed to severe level compared with the standard of care in mild and moderate COVID-19 patients.
3. Assess the efficacy of Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) in addition to the standard of care on reducing the time required to meet discharge standards compared with the standard of care in mild and moderate COVID-19 patients.

This study is investigated by the following hypotheses: combining Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) with the standard of care is effective in reducing the duration and severity of symptoms, reducing the proportion of patients progressed to severe level, and reducing the length of hospital stay on mild and moderate COVID-19 patients

Eligibility criteria: Inclusion Criteria:

* From full 18 to 64 years old;
* The patient was diagnosed with SARS-CoV-2 infection by RT-PCR confirmation (+) and CT \< 30.
* Patients classified as mild (acute upper respiratory tract infection): patients infected with SARS-CoV-2 early in the first 5 days from the time of having one of the non-specific clinical symptoms such as fever, cough dry, sore throat, stuffy nose, fatigue, headache, muscle pain, decreased taste, decreased sense of smell. And there are no signs of pneumonia or hypoxia, respiratory rate ≤ 20 times/min, Saturation of Peripheral Oxygen (SpO2) ≥ 96% when breathing air.
* Patients classified as moderate (Pneumonia): patients infected with SARS-CoV-2 in the first 10 days from the time of having one of the non-specific clinical symptoms, showing signs of pneumonia (fever, cough, dyspnea, tachypnea \>20 breaths/min) and no signs of severe pneumonia, Saturation of Peripheral Oxygen (SpO2) ≥ 93% when breathing air.
* Inpatient treatment
* Subjects do not use any other medicines with herbal ingredients for underlying conditions or any other purposes;
* Voluntary participation in the study by signing an informed consent
* Patients who have not been vaccinated or have just received 1 dose of COVID-19 vaccine

Exclusion Criteria:

* Severe or critical COVID-19 based on the COVID-19 severity scale of Vietnam Ministry of Health;
* Chronic obstructive pulmonary disease, kidney failure requiring dialysis or creatinine ≥ 2.0mg/dl through medical history; parenteral or parenteral nutrition, uncontrolled type 2 diabetes (HbA1c \> 7%), uncontrolled hypertension (value \> 160/100 mmHg), uncontrolled coronary artery disease (new/currently established) requires medication adjustment), heart failure, neurological disease (eg, acute stroke, polyneuritis within 1 month) or mental illness, active tuberculosis, active autoimmune disease;
* Have a chronically weakened immune system (AIDS, cancer, undergoing chemotherapy-radiotherapy in the past six months, immunosuppressive disease);
* Taking immunosuppressive drugs (e.g., anti-rejection treatment after organ transplant or blood stem cell transplant);
* Allergic to products that contain ginseng;
* Pregnant or lactating women;
* Already participating in another clinical trial;
* The patient has received 2 doses of COVID-19 vaccine.

Primary outcomes:
measure: Duration of symptoms of COVID-19
timeFrame: From Day 1 to Day 21 after randomization
measure: The severity of the COVID-19 total and individual symptoms
timeFrame: From Day 1 to Day 21 after randomization
measure: Rate of progression to disease severity
timeFrame: During inpatient treatment, maximum to Day 21 after randomization
measure: The time required to meet discharge standards
timeFrame: During inpatient treatment, maximum to Day 21 after randomization
measure: National Early Warning Score 2 (NEWS2)
timeFrame: During inpatient treatment, maximum to Day 21 after randomization
Secondary outcomes:
measure: Cycle threshold (CT)
timeFrame: During inpatient treatment, maximum to Day 21 after randomization
measure: Duration of SARS-CoV-2 virus infection
timeFrame: During inpatient treatment, maximum to Day 21 after randomization
measure: Mortality rate
timeFrame: From Day 1 to Day 21 after randomization
measure: Number of participants clinically recovered
timeFrame: From Day 1 after randomisation to Day for patients meet discharge criteria
measure: Paracetamol/Ibuprofen intake
timeFrame: From Day 1 after randomisation to Day for patients meet discharge criteria
measure: Safety evaluation
timeFrame: From Day 1 to Day 21 after randomization
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: University of Medicine and Pharmacy at Ho Chi Minh City
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Van-Dan Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: