Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7)

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Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7)

Since December 2019, the novel coronavirus (SARS-CoV-2), which causes COVID-19, has spread from Wuhan, Hubei Province, to communities across China and the world. As an acute respiratory infectious disease, COVID-19 was classified as a Class B infectious disease under China’s Law on Prevention and Treatment of Infectious Diseases but managed with Class A strictness to contain its spread. By early 2020, China had slowed domestic transmission—but global cases were rising. To address new insights into the virus’s behavior, improve early diagnosis, and refine treatment, the National Health Commission and National Administration of Traditional Chinese Medicine updated their guidance to create the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7). Released on March 3, 2020, this protocol builds on earlier versions with data-driven insights into clinical presentation, pathology, and integrated Western and traditional Chinese medicine (TCM) care.

What We Know About the COVID-19 Virus

COVID-19 is caused by a β-genus coronavirus with an envelope (a lipid outer layer) and a round/oval shape (60–140 nm in diameter). Genetic testing shows it shares over 85% homology with bat SARS-like coronaviruses (bat-SL-CoVZC45), suggesting a zoonotic origin. In lab settings, the virus grows in human respiratory epithelial cells in ~96 hours but takes longer (6 days) in Vero E6/Huh-7 cell lines.

Like other coronaviruses (e.g., SARS-CoV, MERS-CoV), COVID-19 is sensitive to heat and UV light: exposure to 56°C for 30 minutes or lipid solvents (ether, 75% ethanol, chlorine-based disinfectants, peracetic acid, chloroform) kills it. Chlorhexidine, however, is ineffective.

Who Is at Risk and How COVID-19 Spreads

  1. Source of Infection: Confirmed COVID-19 patients are the main source, but asymptomatic carriers (people with no symptoms but positive tests) can also spread the virus.
  2. Transmission: The virus spreads primarily through respiratory droplets (e.g., coughing, sneezing) and close contact (within 1 meter of an infected person). In closed spaces with poor ventilation, aerosol transmission (inhalation of tiny virus-containing particles) is possible after prolonged exposure to high concentrations. The virus has also been found in feces/urine, so contaminated surfaces or air from sewage may pose a risk.
  3. Susceptibility: Everyone is vulnerable—no age or gender group is immune.

How COVID-19 Affects the Body

Limited autopsy and biopsy studies reveal how the virus damages organs:

  • Lungs: The most affected organ. Alveoli (air sacs) fill with fluid, fibrin, and hyaline membranes (thick layers that block oxygen). Type II pneumocytes (cells that produce lung surfactant) become overactive or slough off. Viral particles are found in these cells and macrophages. Severe cases show hemorrhage, necrosis, or fibrosis.
  • Spleen/Lymph Nodes: The spleen shrinks, and lymphocytes (white blood cells that fight infection) decrease. Lymph nodes have focal necrosis.
  • Heart/Vessels: Myocardial cells degenerate or die, with mild inflammation. Blood vessels may have damaged endothelial cells, inflammation, or blood clots.
  • Liver/Gallbladder: The liver enlarges and shows cell damage; the gallbladder is often distended.
  • Kidneys: Protein builds up in kidney filters (Bowman’s capsule), and tubule cells degenerate. Clots or fibrosis may occur.
  • Other Organs: Brain swelling, adrenal gland necrosis, and GI tract damage (e.g., esophageal/stomach lining erosion) are common.

What COVID-19 Symptoms Look Like

  • Incubation Period: 1–14 days (most commonly 3–7 days) from exposure to symptom onset.
  • Common Symptoms: Fever, fatigue, and dry cough are the “classic triad.” Some people have nasal congestion, runny nose, sore throat, muscle pain, or diarrhea.
  • Severe/Critical Symptoms: After 1 week, severe cases progress to dyspnea (shortness of breath) or hypoxemia (low blood oxygen). Critical cases may develop acute respiratory distress syndrome (ARDS), septic shock, metabolic acidosis, coagulopathy, or multiple organ failure. Notably, severe/critical patients may have no fever or only low-grade fever.
  • Atypical Symptoms: Children (including newborns) may have GI issues (vomiting, diarrhea), lethargy, or rapid breathing instead of fever.
  • Mild Cases: Some people have low fever and fatigue but no pneumonia on imaging.

Prognosis

Most patients recover, but elderly people or those with chronic diseases (e.g., diabetes, heart disease) have higher risks of severe illness. Pregnant women have similar outcomes to non-pregnant peers; children usually have milder symptoms.

Lab Tests

  • Early stages: Normal or low white blood cell (WBC) count, low lymphocytes.
  • Inflammation: Elevated C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and lactate dehydrogenase (LDH).
  • Severe cases: Rising D-dimer (a clotting marker) and falling lymphocytes.
  • Serology: IgM antibodies (first immune response) appear 3–5 days after onset; IgG (long-term immunity) rises later (4-fold increase in convalescence confirms infection).

Imaging

  • Early: Small patchy shadows or interstitial changes (affecting lung tissue between air sacs), mostly in the outer lungs.
  • Progression: Multiple ground-glass opacities (hazy areas) or consolidation (solid lung tissue). Pleural effusion (fluid around lungs) is rare.

How Doctors Identify Suspected and Confirmed Cases

Suspect Cases

A person is “suspected” if they meet one epidemiological criterion + two clinical criteria, or all three clinical criteria (no clear exposure history):

Epidemiological History

  1. Travel/residence in Wuhan/surrounding areas or a community with confirmed cases in the 14 days before symptoms.
  2. Contact with a COVID-19 patient (positive test) in the past 14 days.
  3. Contact with someone from Wuhan/surrounding areas or a confirmed community who has fever/respiratory symptoms.
  4. Clustered cases (2+ people with fever/respiratory symptoms in a small group—family, office, school—within 2 weeks).

Clinical Criteria

  1. Fever/respiratory symptoms.
  2. Typical COVID-19 imaging findings.
  3. Normal/low WBC or lymphocytes in early stages.

Confirmed Cases

A suspect case becomes “confirmed” with one of the following:

  1. Positive real-time RT-PCR test (detects viral RNA in nasopharyngeal swabs, sputum, blood, or feces).
  2. Viral gene sequence matching known COVID-19 strains.
  3. Positive serology: Both IgM and IgG are present, or IgG shows a 4-fold increase between acute and convalescent phases.

Severity Levels of COVID-19

Doctors categorize cases to guide treatment:

  1. Mild: Mild symptoms (e.g., low fever, fatigue) with no pneumonia on imaging.
  2. Moderate: Fever, respiratory symptoms, and pneumonia on imaging.
  3. Severe:
    • Adults: Respiratory rate ≥30 breaths/min, resting oxygen saturation (SpO2) ≤93%, or PaO2/FiO2 (oxygenation index) ≤300 mmHg. For high-altitude areas (over 1,000 meters), adjust PaO2/FiO2 using: PaO2/FiO2 × (Atmospheric Pressure/760). Rapid lung lesion progression (>50% in 24–48 hours) also counts as severe.
    • Children: Rapid breathing (e.g., ≥60 breaths/min for <2-month-olds), SpO2 ≤92%, labored breathing (nasal flaring, chest retractions), cyanosis (blue skin), lethargy, convulsions, or dehydration.
  4. Critical: Requires mechanical ventilation, has septic shock, or needs ICU care for organ failure.

Red Flags for Severe or Critical Disease

Doctors monitor these signs to intervene early:

  • Adults: Falling lymphocytes, rising IL-6/CRP/lactate, or rapid lung lesion growth.
  • Children: Increased respiratory rate, poor mental status, rising lactate, bilateral lung infiltrates, or underlying conditions (e.g., congenital heart disease, immune deficiency) in infants <3 months.

How COVID-19 Is Distinguished from Other Illnesses

COVID-19 symptoms overlap with many conditions—doctors use tests to rule out:

  1. Upper Respiratory Infections: Caused by other viruses (e.g., rhinovirus).
  2. Other Pneumonias: Viral (influenza, adenovirus), bacterial, or mycoplasma. Rapid antigen tests or multiplex PCR help detect common pathogens.
  3. Non-Infectious Diseases: Vasculitis (blood vessel inflammation), dermatomyositis (muscle/skin inflammation), or organizing pneumonia (scarring from lung injury).

What Happens When a Case Is Suspected

  1. Isolation: Suspected cases are immediately placed in a single room to prevent spread.
  2. Reporting: If experts confirm suspicion, the case is reported online within 2 hours.
  3. Testing: Nasopharyngeal swabs, sputum, or other samples are sent for RT-PCR.
  4. Transfer: Suspected cases are taken to designated hospitals with isolation capabilities.
  5. Ruling Out: A suspect case is cleared if:
    • Two negative RT-PCR tests (24 hours apart), AND
    • Negative IgM/IgG at 7 days after onset.

Close contacts of confirmed cases should get tested even if other respiratory pathogens are positive.

How COVID-19 Is Treated

Treatment depends on severity and combines Western medicine (WM) and traditional Chinese medicine (TCM).

1. Where to Get Care

  • Suspected/Confirmed Cases: Isolated in designated hospitals with infection control measures.
  • Critical Cases: Admitted to the ICU immediately.

2. General Care (All Cases)

  • Rest: Stay in bed to conserve energy.
  • Supportive Therapy: Maintain fluid/electrolyte balance; ensure adequate calories.
  • Oxygen: Nasal cannula, mask, or high-flow nasal oxygen for hypoxemia. Hydrogen-oxygen mix (66.6% H2, 33.3% O2) is optional.
  • Avoid Over-Treatment: No unnecessary antibiotics (to prevent resistance).

3. Antiviral Therapy

Doctors may use:

  • Alpha-Interferon: 5 million U (adults) via nebulizer twice daily.
  • Lopinavir/Ritonavir: 2 pills (200 mg/50 mg each) twice daily for ≤10 days.
  • Ribavirin: 500 mg IV twice/thrice daily (combined with interferon/lopinavir/ritonavir) for ≤10 days.
  • Chloroquine Phosphate: 500 mg twice daily for 7 days (adults ≥18; adjust for weight <50 kg).
  • Arbidol: 200 mg three times daily for ≤10 days.

Warnings: Avoid combining >3 antivirals. Stop if side effects (e.g., chloroquine for heart disease) occur. Pregnant women need risk-benefit discussions (e.g., drug safety for the fetus).

4. Severe/Critical Case Management

  • Respiratory Support:
    • Non-Invasive Ventilation: For patients with unrelieved hypoxemia. If no improvement in 1–2 hours, switch to invasive ventilation.
    • Invasive Ventilation: Use “lung-protective” settings (low tidal volume: 6–8 ml/kg ideal body weight; platform pressure 12 hours/day helps in severe ARDS.
    • ECMO: Extracorporeal membrane oxygenation (a heart-lung machine) is used for refractory ARDS (e.g., FiO2 >90% with PaO2/FiO2 <80 mmHg for 3–4 hours).
  • Circulatory Support: Fluids to maintain blood pressure; vasoactive drugs (e.g., norepinephrine) for shock. Monitor lactate, urine output, and hemodynamics (e.g., echocardiography).
  • Renal Support: Continuous renal replacement therapy (CRRT) for kidney failure (e.g., hyperkalemia, fluid overload).
  • Convalescent Plasma: Plasma from recovered patients (contains antibodies) for rapid progression or severe/critical cases.
  • Blood Purification: Removes inflammatory cytokines to stop “cytokine storm” (overactive immune response).
  • Immunotherapy: Tocilizumab (anti-IL-6 antibody) for severe cases with high IL-6 levels. Dose: 4–8 mg/kg (max 800 mg) IV over 1 hour; no more than 2 doses.
  • Other: Short-term glucocorticoids (1–2 mg/kg methylprednisolone daily for 3–5 days) for excessive inflammation. Xuebijing injection (100 ml IV twice daily) or intestinal probiotics (to prevent secondary infections) may help.

Special Populations

  • Children: Severe cases get IV γ-globulin.
  • Pregnant Women: Severe/critical cases may need a cesarean section to protect the mother.
  • Mental Health: Anxiety/fear is common—psychological counseling is recommended.

5. Traditional Chinese Medicine (TCM)

TCM classifies COVID-19 as a “plague” caused by “epidemic pathogenic qi” . Treatment varies by stage and symptom pattern:

  • Medical Observation:

    • Fatigue + GI discomfort: Huoxiang Zhengqi capsules/pills.
    • Fatigue + fever: Jinhua Qinggan granules, Lianhua Qingwen capsules, or Shufeng Jiedu granules.

  • Confirmed Cases:

    • Mild:
    • Cold Dampness Stagnation: Prescription includes Ephedra (6 g), Gypsum (15 g), Apricot Seed (9 g), and others. Boil 600 ml water; take 1/3 three times daily before meals.
    • Damp Heat Accumulation: Areca Seed (10 g), Tsaoko Fruit (10 g), and others. Boil 400 ml; take twice daily.
    • Moderate:
    • Dampness Stagnation: Ephedra (6 g), Bitter Apricot Seed (15 g), and others. Twice daily.
    • Cold Dampness: Atractylodes Rhizome (15 g), Tangerine Peel (10 g), and others. Twice daily.
    • Severe:
    • Plague Poison Lung Closure: Ephedra (6 g), Apricot Seed (9 g), and others. 1–2 doses daily (oral/nasal feeding).
    • Qi-Ying Blazing: Gypsum (30–60 g), Anemarrhena Rhizome (30 g), and others. Twice daily.
    • Critical: Ginseng (15 g), Prepared Aconite (10 g), and Cornus Fruit (15 g) with Suhexiang Pill/Angong Niuhuang Pill.
    • Convalescence:
    • Lung-Spleen Qi Deficiency: Pinellia (9 g), Tangerine Peel (10 g), and others. Twice daily.
    • Qi-Yin Deficiency: Adenophora (10 g), Glehnia (10 g), and others. Twice daily.

TCM Injections: For severe/critical cases—Xiyanping, Xuebijing, Reduning, Tanreqing, Xingnaojing, Shenfu, or Shengmai. Doses follow guidelines (e.g., Xuebijing 100 ml IV twice daily for organ failure).

When Can Patients Go Home?

Patients are discharged if:

  1. Fever-free for >3 days.
  2. Respiratory symptoms (e.g., cough, shortness of breath) improve.
  3. Lung imaging shows reduced inflammation.
  4. Two negative RT-PCR tests (24 hours apart) from respiratory samples (e.g., sputum, nasopharyngeal swabs).

After Discharge

  • Isolation: Self-monitor for 14 days in a well-ventilated room. Wear a mask, avoid close contact with family, use separate dishes, and practice hand hygiene.
  • Follow-Up: Return to the hospital for check-ups at 2 and 4 weeks post-discharge.
  • Communication: Hospitals share records with local health centers/community committees to ensure ongoing care.

How to Safely Move Patients

Patients are transferred per the Work Protocol for Transfer of Novel Coronavirus Pneumonia Patients (Trial Version) (National Health Commission) to ensure minimal spread.

Keeping Hospitals Safe

Hospitals follow the Technical Guidelines for the Prevention and Control of Infection by the Novel Coronavirus in Medical Institutions (First Edition) and Guidelines on the Usage of Common Medical Protective Equipment (National Health Commission). Key measures: PPE (masks, gloves, gowns), hand hygiene, and isolation rooms.

Original Source and Copyright

This protocol was released by the General Office of the National Health Commission and Office of the National Administration of Traditional Chinese Medicine on March 3, 2020. It was published in the Chinese Medical Journal (2020;133(9)) by the Chinese Medical Association and produced by Wolters Kluwer under the CC-BY-NC-ND 4.0 License (free to download/share with credit; no commercial use or modifications). The Trial Version 6 is available

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