Efficacy and Safety of High-dose Vitamin C Combined With Chinese Medicine Against Coronavirus Pneumonia (COVID-19)
Condition: COVID-19
MeSH terms: COVID-19; Pneumonia
Study type: Interventional

Summary: 
      In December 2019, coronavirus pneumonia (COVID-19) was detected in many cases in Wuhan,
      China. With the rapid spread of the coronavirus, cases of COVID-19 were also reported in
      other cities of China and other countries. COVID-19 can cause amplification of the pulmonary
      inflammatory responses, including the production of a large amount of free radicals and the
      release of inflammatory factors, in a short time after infection, leading to lung tissue
      damage and dysfunction, even resulting in life-threatening respiratory distress syndrome and
      respiratory failure. At present, there are no effective drugs targeting COVID-19. Previous
      studies have shown that Buzhong Yiqi Decoction has anti-bacterial, anti-viral, and
      anti-allergy effects. High-dose vitamin C also has anti-oxidative and anti-toxin effects,
      possibly exhibiting good effects in the treatment of viral infection and critical respiratory
      diseases. The study objectives include (1) investigate whether Buzhong Yiqi Decoction can
      improve the clinical symptoms of patients with mild and severe COVID-19 and accelerate
      recovery and to further investigate the clinical efficacy of high-dose vitamin C combined
      with traditional Chinese medicine in the treatment of mild and severe COVID-19; (2) to assess
      the safety of high-dose vitamin C combined with Chinese medicine in the treatment of mild and
      severe COVID-19.
    

Detailed description: 
      Preparation prior to treatment

        1. Record of age, sex, race, height, body mass, body mass index, body temperature, blood
           pressure, pulse, and respiratory rate;

        2. Record of previous medical history, current medical history, treatment history,
           concomitant disease/treatment history;

        3. Record of laboratory tests: routine blood test, routine stool and urine tests, fecal
           occult blood test, C-reactive protein measurement, biochemical assay, PCR testing for
           respiratory virus, tumor marker test, and ABO typing

        4. Cytokine detection: Serum levels of interleukin-6, interleukin-10, and tumor necrosis
           factor-alpha (TNF-α)

        5. Auxiliary examination: Chest CT for assessment of lung infection

      Chinese medicine treatments Chinese medicine treatments include oral administration of
      concentrated Chinese herbal decoction, fumigation/inhalation of Chinese medicine and vitamin
      C, and bolus administration of vitamin C.

      Traditional Chinese and western medicine prescription details Traditional Chinese medicine
      treatment details Prescription 1: Buzhong Yiqi plus and minus formula (recommended for
      patients who had no fever and those who are in the convalescent period): This formula is
      composed of Radix Astragali 30 g, Radix Ginseng 15 g, Radix Glycyrrhizae 15 g, Rhizoma
      Atractylodis Macrocephalae 10 g, Pericarpium Citri Reticulatae 6 g, Radix Angelicae Sinensis
      10 g, Fructus Jujubae 6, Rhizoma Zingiberis Recens 9 pieces, Radix Bupleuri 12 g, Rhizoma
      Cimicifugae 6 g.

      Preparation method: The aforementioned herbs are decocted with water. After removal of
      macromolecules, 50 g concentrate is left, and then packaged, 25 g/dose.

      Suggested usage: 1 dose once, twice a day, taking with warm water.

      Prescription 2: Huhuang Detoxicity Paste (recommended for patients who have no fever): This
      formula is composed of Rhizoma Coptidis 20 g, Radix Et Rhizoma Rhei 10 g, Rhizoma
      Atractylodis 10 g, Radix Asteris 10 g, Herba Houttuyniae 10 g, Herba Taraxaci 10 g, Rhizoma
      Polygoni Cuspidati 10 g, Radix Astragali 20 g.

      Preparation method: The aforementioned herbs are boiled with water. The extract was subjected
      to high-speed centrifugation. After removal of impurities, 50 g concentrate is left, and then
      packaged, 25 g/dose.

      Suggested usage: One dose once, twice a day, taking with warm water.

      Prescription 3: Baimu Qingre Jiedu Paste This formula is composed of Radix Puerariae 15 g,
      Radix Angelicae Dahuricae 12 g, Flos Magnoliae 9 g, Radix Isatidis 30 g, Fructus Forsythiae
      15 g, Bulbus Fritillariae Thunbergii 12 g Preparation method: The aforementioned herbs are
      boiled with water. The extract was subjected to high-speed centrifugation. After removal of
      impurities, 50 g concentrate is left, and then packaged, 25 g/dose.

      Suggested usage: One dose once, twice a day, taking with warm water.

      Prescription 4: Fumigation/inhalation of Chinese herbs and vitamin C The formula consists of
      Rhizoma Coptidis 20 g, Radix Et Rhizoma Rhei 10 g, Rhizoma Atractylodis Macrocephalae 10 g,
      Radix Astragali 10 g, Radix Asteris 10 g, Herba Houttuyniae 10 g, Herba Taraxaci 10 g,
      Rhizoma Polygoni Cuspidati 10 g, Radix Astragali 20 g.

      Preparation method: The aforementioned herbs are boiled with water. The extract was subjected
      to high-speed centrifugation. After removal of impurities, 50 g concentrate is left, and then
      packaged, 25 g/dose.

      Fumigation/inhalation method: 3L of water is added to the intelligent rice cooker
      (specification 5L), and then the aforementioned semifluid paste is also placed in the cooker.
      After boiling, 10 g vitamin C is added. The oxygen tube is inserted into the bottom of the
      traditional Chinese medicine solution (oxygen flow is about 3-4 L/min). The steam is sucked
      with the mouth and nose alternately, 30-40 minutes once, 3-7 times a day. Patients take
      vitamin E capsule and folic acid every day.

      Bolus administration of vitamin C 100 mL of 5% glucose containing vitamin C (10 g/60 kg body
      mass) is intravenously administered twice a day.

      Western medicine treatment details Atomized inhalation of 5 million U α-interferon and 2 mL
      sterilized water, twice a day; 0.2 g arbidol, three times a day, treatment course no more
      than 10 days; intravenous administration of ribavirin 500 mg, once every 12 hours, treatment
      course no more than 10 days; intravenous administration of 10 g immunoglobulin C, once a day,
      3-5 days. Anti-bacterial infection treatment is given to the patients who have yellow sputum
      and increased levels of procalcitonin and other bacterial infection specific indicators.

      Notes for case and course record The medical record of integrated Chinese and western
      medicine treatment for each case should be carefully filled. A summary of the medical record
      is made every three days. The name and dosage of the traditional Chinese medicine and western
      medicine used, the route of administration, curative effect, and side effects are recorded.
      The record form of the curative effect should be filled every day.
    

Intervention name(s): Alpha-interferon alpha, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste, fumigation/inhalation of vitamin C; Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and 5% glucose; Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and high-dose vitamin C treatment
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Atomized inhalation of 5 million U α-interferon and 2 mL sterilized water, twice a day; 0.2 g arbidol, three times a day, treatment course no more than 10 days; intravenous administration of ribavirin 500 mg, once every 12 hours, treatment course no more than 10 days; intravenous administration of 10 g immunoglobulin C, once a day, 3-5 days. Anti-bacterial infection treatment is given to the patients who have yellow sputum and increased levels of procalcitonin and other bacterial infection specific indicators.; Buzhong Yiqi plus and minus formula: 1 dose once, twice a day, taking with warm water. Huhuang Detoxicity Paste: One dose once, twice a day, taking with warm water; Baimu Qingre Jiedu Paste: One dose once, twice a day, taking with warm water; Fumigation/inhalation of Chinese herbs and vitamin C: 30-40 minutes once, 3-7 times a day. Patients take vitamin E capsule and folic acid every day. plus invention 1; invention 1 plus invention 2 plus 100 mL of 5% glucose containing vitamin C (10 g/60 kg body mass) is intravenously administered twice a day.
Other intervention name(s): Western medicine treatment; Traditional Chinese medicine treatment plus Western medicine treatment; Traditional Chinese medicine treatment plus Western medicine treatment plus Bolus administration of vitamin C
Intervention MeSH terms: Vitamins; Ascorbic Acid; Interferons; Ribavirin; Interferon-alpha; Interferon-alfa-1b
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: participants are assigned to one of two or more groups in parallel for the duration of the study
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: COVID-19; vitamin C; traditional Chinese medicine