Diagnosis and Treatment Protocol For Novel Coronavirus Pneumonia
Diagnosis and Treatment Protocol For Novel Coronavirus Pneumonia
Diagnosis and Treatment Protocol For Novel Coronavirus Pneumonia
Coronavirus Pneumonia
(Trial Version 7)
(Released by National Health Commission & State Administration of
Traditional Chinese Medicine on March 3, 2020)
Since December 2019, multiple cases of novel coronavirus pneumonia (NCP) have been
identified in Wuhan, Hubei. With the spread of the epidemic, such cases have also been
found in other parts of China and other countries. As an acute respiratory infectious disease,
NCP has been included in Class B infectious diseases prescribed in the Law of the People's
Republic of China on Prevention and Treatment of Infectious Diseases, and managed as an
infectious disease of Class A. By taking a series of preventive control and medical
treatment measures, the rise of the epidemic situation in China has been contained to a
certain extent, and the epidemic situation has eased in most provinces, but the incidence
abroad is on the rise. With increased understanding of the clinical manifestations and
pathology of the disease, and the accumulation of experience in diagnosis and treatment,
in order to further strengthen the early diagnosis and early treatment of the disease, improve
the cure rate, reduce the mortality rate, avoid nosocomial infection as much as possible and
pay attention to the spread caused by the imported cases from overseas, we revised the
Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 6) to
Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7).
I. Etiological Characteristics
The novel coronaviruses belong to the β genus. They have envelopes, and the particles are
round or oval, often polymorphic, with diameter being 60 to 140 nm. Their genetic
characteristics are significantly different from SARS-CoV and MERS-CoV. Current
research shows that they share more than 85% homology with bat SARS-like coronaviruses
(bat-SL-CoVZC45). When isolated and cultured in vitro, the 2019-nCoV can be found in
human respiratory epithelial cells in about 96 hours, however it takes about 6 days for the
virus to be found if isolated and cultured in Vero E6 and Huh-7 cell lines.
Most of the know-how about the physical and chemical properties of coronavirus comes
from the research on SARS-CoV and MERS-CoV. The virus is sensitive to ultraviolet and
heat. Exposure to 56°C for 30 minutes and lipid solvents such as ether, 75% ethanol,
chlorine-containing disinfectant, peracetic acid, and chloroform can effectively inactivate
the virus. Chlorhexidine has not been effective in inactivating the virus.
2. Laboratory tests
General findings
In the early stages of the disease, peripheral WBC count is normal or decreased and the
lymphocyte count decreases. Some patients see an increase in liver enzymes, lactate
dehydrogenase (LDH), muscle enzymes and myoglobin. Elevated troponin is seen in some
critically ill patients while most patients have elevated C-reactive protein and erythrocyte
sedimentation rate and normal procalcitonin. In severe cases, D-dimer increases and
peripheral blood lymphocytes progressively decrease. Severe and critically ill patients
often have elevated inflammatory factors.
Pathogenic and serological findings
(1) Pathogenic findings: Novel coronavirus nucleic acid can be detected in nasopharyngeal
swabs, sputum, lower respiratory tract secretions, blood, feces and other specimens using
RT-PCR and/or NGS methods. It is more accurate if specimens from lower respiratory
tract (sputum or air tract extraction) are tested. The specimens should be submitted for
testing as soon as possible after collection.
(2) Serological findings: NCP virus specific IgM becomes detectable around 3-5 days after
onset; IgG reaches a titration of at least 4-fold increase during convalescence compared
with the acute phase.
3. Chest imaging
In the early stage, imaging shows multiple small patchy shadows and interstitial changes,
apparent in the outer lateral zone of lungs. As the disease progresses, imaging then shows
multiple ground glass opacities and infiltration in both lungs. In severe cases, pulmonary
consolidation may occur while pleural effusion is rare.
V. Case Definitions
1. Suspect cases
Considering both the following epidemiological history and clinical manifestations:
1.1 Epidemiological history
1.1.1 History of travel to or residence in Wuhan and its surrounding areas, or in other
communities where cases have been reported within 14 days prior to the onset of the
disease;
1.1.2 In contact with novel coronavirus infected people (with positive results for the nucleic
acid test) within 14 days prior to the onset of the disease;
1.1.3 In contact with patients who have fever or respiratory symptoms from Wuhan and its
surrounding area, or from communities where confirmed cases have been reported within
14 days before the onset of the disease; or
1.1.4 Clustered cases (2 or more cases with fever and/or respiratory symptoms in a small
area such families, offices, schools etc within 2 weeks).
2. Confirmed cases
Suspect cases with one of the following etiological or serological evidences:
2.1 Real-time fluorescent RT-PCR indicates positive for new coronavirus nucleic acid;
2.2 Viral gene sequence is highly homologous to known new coronaviruses.
2.3 NCP virus specific Ig M and IgG are detectable in serum; NCP virus specific IgG is
detectable or reaches a titration of at least 4-fold increase during convalescence compared
with the acute phase.
4. Critical cases
Cases meeting any of the following criteria:
4.1 Respiratory failure and requiring mechanical ventilation;
4.2 Shock;
4.3 With other organ failure that requires ICU care.
2. Children.
2.1 Respiratory rate increased;
2.2 Poor mental reaction and drowsiness;
2.3 Lactate increases progressively;
2.4 Imaging shows infiltration on both sides or multiple lobes, pleural effusion or rapid
progress of lesions in a short period of time;
2.5 Infants under the age of 3 months who have either underlying diseases (congenital heart
disease, bronchopulmonary dysplasia, respiratory tract deformity, abnormal hemoglobin,
and severe malnutrition, etc.) or immune deficiency or hypofunction (long-term use of
immunosuppressants).
X. Treatment
1. Treatment venue determined by the severity of the disease
1.1 Suspected and confirmed cases should be isolated and treated at designated hospitals
with effective isolation, protection and prevention conditions in place. A suspect case
should be treated in isolation in a single room. Confirmed cases can be treated in the same
room.
1.2 Critical cases should be admitted to ICU as soon as possible.
2. General treatment
2.1 Letting patients rest in bed and strengthening support therapy; ensuring sufficient
caloric intake for patients; monitoring their water and electrolyte balance to maintain
internal environment stability; closely monitoring vital signs and oxygen saturation.
2.2 According to patients’ conditions, monitoring blood routine result, urine routine result,
c-reactive protein (CRP), biochemical indicators (liver enzyme, myocardial enzyme, renal
function etc.), coagulation function, arterial blood gas analysis, chest imaging and
cytokines detection if necessary.
2.3 Timely providing effective oxygen therapy, including nasal catheter and mask
oxygenation and nasal high-flow oxygen therapy. If possible, inhalation of mixed hydrogen
and oxygen (H2/O2: 66.6%/33.3%) can be applied.
2.4 Antiviral therapy: Hospitals can try Alpha-interferon (5 million U or equivalent dose
each time for adults, adding 2ml of sterilized water, atomization inhalation twice daily),
lopinavir/ritonavir (200 mg/50mg per pill for adults, two pills each time, twice daily, no
longer than 10 days), Ribavirin (suggested to be used jointly with interferon or
lopinavir/ritonavir, 500 mg each time for adults, twice or three times of intravenous
injection daily, no longer than 10 days), chloroquine phosphate (500 mg bid for 7 days for
adults aged 18-65 with body weight over 50 kg; 500 mg bid for Days 1&2 and 500 mg qd
for Days 3-7 for adults with body weight below 50 kg), Arbidol (200 mg tid for adults, no
longer than 10 days). Be aware of the adverse reactions, contraindications (for example,
chloroquine cannot be used for patients with heart diseases) and interactions of the above-
mentioned drugs. Further evaluate the efficacy of those drugs currently being used. Using
three or more antiviral drugs at the same time is not recommend; if an intolerable toxic side
effect occurs, the respective drug should be discontinued. For the treatment of pregnant
women, issues such as the number of gestational weeks, choice of drugs having the least
impact on the fetus, as well as whether pregnancy being terminated before treatment should
be considered with patients being informed of these considerations.
2.5 Antibiotic drug treatment: Blind or inappropriate use of antibiotic drugs should be
avoided, especially in combination with broad-spectrum antibiotics.
3.4 Renal failure and renal replacement therapy: Active efforts should be made to look
for causes for renal function damage in critical cases such as low perfusion and drugs.
For the treatment of patients with renal failure, focus should be on the balance of body
fluid, acid and base and electrolyte balance, as well as on nutrition support including
nitrogen balance and the supplementation of energies and trace elements. For critical
cases, continuous renal replacement therapy (CRRT) can be used. The indications
include: ① hyperkalemia; ② acidosis; ③ pulmonary edema or water overload; ④
fluid management in multiple organ dysfunction.
3.5 Convalescent plasma treatment: It is suitable for patients with rapid disease progression,
severe and critically ill patients. Usage and dosage should refer to Protocol of Clinical
Treatment with Convalescent Plasma for NCP Patients (2nd trial version).
3.6 Blood purification treatment: Blood purification system including plasma exchange,
absorption, perfusion and blood/plasma filtration can remove inflammatory factors and
block "cytokine storm", so as to reduce the damage of inflammatory reactions to the body.
It can be used for the treatment of severe and critical cases in the early and middle stages
of cytokine storm.
3.7 Immunotherapy: For patients with extensive lung lesions and severe cases who also
show an increased level of IL-6 in laboratory testing, Tocilizumab can be used for treatment.
The initial dose is 4-8mg/kg with the recommended dose of 400mg diluted with 0.9%
normal saline to 100ml. The infusion time should be more than 1 hour. If the initial
medication is not effective, one extra administration can be given after 12 hours (same dose
as before). No more than two administrations should be given with the maximum single
dose no more than 800mg. Watch out for allergic reactions. Administration is forbidden
for people with active infections such as tuberculosis.
3.8 Other therapeutic measures
For patients with progressive deterioration of oxygenation indicators, rapid progress in
imaging and excessive activation of the body's inflammatory response, glucocorticoids can
be used in a short period of time (three to five days). It is recommended that dose should
not exceed the equivalent of methylprednisolone 1-2 mg/kg/day. Note that a larger dose of
glucocorticoid will delay the removal of coronavirus due to immunosuppressive effects.
Xuebijing 100ml/time can be administered intravenously twice a day. Intestinal
microecological regulators can be used to maintain intestinal microecological balance and
prevent secondary bacterial infections.
Child severe and critical cases can be given intravenous infusion of γ-globulin.
For pregnant severe and critical cases, pregnancy should be terminated preferably with c-
section.
Patients often suffer from anxiety and fear and they should be supported by psychological
counseling.
Note: Recommended usage of Chinese medicine injections for severe and critical cases
The use of traditional Chinese medicine injections follows the principle of starting from a
small dose and gradually adjusting the dosage according to the instructions of the drug.
The recommended usage is as follows:
Viral infection or combined mild bacterial infection: 0.9% sodium chloride injection 250ml
plus Xiyanping injection 100mg bid, or 0.9% sodium chloride injection 250ml heated
Duning injection 20ml, or 0.9% sodium chloride injection 250ml plus Tanreqing injection
40ml bid.
High fever with disturbance of consciousness: 250ml of 0.9% sodium chloride injection
and 20ml bid of Xingnaojing injection.
Systemic inflammatory response syndrome or/and multiple organ failure: 250ml of 0.9%
sodium chloride injection and 100ml of Xuebijing injection.
Immunosuppression: 250ml of 0.9% sodium chloride injection and 100ml bid of Shenmai
injection.
Shock: 250ml of 0.9% sodium chloride injection plus 100ml bid of Shenfu injection.
2. After-discharge considerations
2.1 The designated hospitals should contact the primary healthcare facilities where the
patients live and share patients’ medical record, to send the information of the discharged
patients to the community committee and primary healthcare facility where the patients
reside.
2.2. After discharge, it is recommended for patients to monitor their own health status in
isolation for 14 days, wear a mask, live in well-ventilated single room if possible, reduce
close contact with family members, separate dinning, practice hand hygiene and avoid
going out.
2.3 It is recommended for the patients to return to the hospitals for follow-up and re-visit
in two and four weeks after discharge.