Clinical Management Protocol issued by Health Ministry

Clinical Management Protocol issued by Health Ministry

Ministry of Health and Family Welfare has issued the protocol for Clinical Management in Corona Virus Situation. This protocol also describes the clinical management of mild cases of corona, moderate cases, and severe cases. Prevention of complications is also described in this protocol.
1. Background
Coronaviruses are large group of viruses that cause illness in humans and animals. Rarely, animal coronaviruses can evolve and infect people and then spread between people such as has been seen with MERS and SARS. The outbreak of Novel coronavirus disease (COVID-19) was initially noticed in a seafood market in Wuhan city in Hubei Province of China in mid-December, 2019, has now spread to 214 countries/territories/areas worldwide. WHO (under International Health Regulations) has declared this outbreak as a “Public Health Emergency of International Concern” (PHEIC) on 30thJanuary 2020. WHO subsequently declared COVID-19 a pandemic on 11th March, 2020.
2. Disease Epidemiology

Current available evidence for COVID-19 suggests that the causative virus (SARS-CoV-2) has a zoonotic source closely related to bat-origin SARS-like coronavirus. It is an enveloped RNA beta coronavirus related to the Severe Acute Respiratory Syndrome (SARS) virus, and the virus has been shown to use the angiotensin-converting enzyme 2 (ACE2) receptor for cell entry.
The persons infected by the novel coronavirus are the main source of infection. Direct person-to-person transmission occurs through close contact, mainly through respiratory droplets that are released when the infected person coughs, sneezes, or talks. These droplets may also land on surfaces, where the virus remains viable. Infection can also occur if a person touches an infected surface and then touches his or her eyes, nose, or mouth.
The median incubation period is 5.1 days (range 2–14 days). The precise interval during which an individual with COVID-19 is infectious is uncertain. As per the current evidence, the period of infectivity starts 2 days prior to onset of symptoms and lasts up to 8 days. The extent and role played by pre-clinical/ asymptomatic infections in transmission still remain under investigation.
3. Patho-physiology
Most patients with COVID-19 predominantly have a respiratory tract infection associated with SARS-CoV-2 infection. However, in a small proportion of cases, they can progress to a more severe and systemic disease characterized by the Acute Respiratory Distress Syndrome (ARDS), sepsis and septic shock, multiorgan failure, including acute kidney injury and cardiac injury.
Autopsy findings in China and European countries showed endothelial damage of pulmonary vasculature, microvascular thrombosis and hemorrhage linked to extensive alveolar and interstitial inflammation that ultimately result in COVID-19 vasculopathy, pulmonary intravascular coagulopathy, hypercoagulability, ventilation perfusion mismatch, and refractory ARDS. Hypoxemia, secondary to ARDS may also activate the coagulation cascade.
4. Case definition1
Suspect case
A. A patient with acute respiratory illness (fever and at least one sign/symptom of respiratory disease, e.g., cough, shortness of breath), AND a history of travel to or residence in a location reporting community transmission of COVID-19 disease during the 14 days prior to symptom onset;
B. A patient with any acute respiratory illness AND having been in contact with a confirmed or probable COVID-19 case in the last 14 days prior to symptom onset;
C. A patient with severe acute respiratory illness (fever and at least one sign/symptom of respiratory disease, e.g., cough, shortness of breath; AND requiring hospitalization) AND in the absence of an alternative diagnosis that fully explains the clinical presentation.
Probable case

A. A suspect case for whom testing for the COVID-19 virus is inconclusive.
B. A suspect case for whom testing could not be performed for any reason. 
Confirmed case 
A person with laboratory confirmation of COVID-19 infection, irrespective of clinical signs and symptoms.
5. Clinical Features
COVID-19 patients reporting to various Covid treatment facilities have reported the following signs and symptoms:
  • Fever
  • Cough
  • Fatigue
  • Shortness of breath
  • Expectoration
  • Myalgia
  • Rhinorrhea, sore throat, diarrhea
  • Loss of smell (anosmia) or loss of taste (ageusia) preceding the onset of respiratory symptoms has also been reported
Older people and immune-suppressed patients in particular may present with atypical symptoms such as fatigue, reduced alertness, reduced mobility, diarrhoea, loss of appetite, delirium, and absence of fever. Children might not have reported fever or cough as frequently as adults.
As per data from Integrated Health Information Platform (IHIP)/ Integrated Disease Surveillance Programme (IDSP) portal case investigation forms for COVID 19 (n=15,366), the details on the signs and symptoms reported are (as on 11.06.2020), fever (27%), cough (21%), sore throat (10%), breathlessness (8%), Weakness (7%), running nose (3%) and others 24%.
6. Risk factors
The major risk factors for severe disease are:
  • Age more than 60 years (increasing with age).
  • Underlying non-communicable diseases (NCDs): diabetes, hypertension, cardiac disease, chronic lung disease, cerebro-vascular disease, chronic kidney disease, immune-suppression and cancer 
9. Laboratory Diagnosis
Guidance on specimen collection, processing, transportation, including related biosafety procedures, is available at:
Sample collection
Preferred sample Throat and nasal swab in viral transport media (VTM) and transported in cold chain.

Nasopharyngeal swab, BAL or endotracheal aspirate which has to be mixed with the viral transport medium and transported in cold chain.
General guidelines
  • Use appropriate PPE for specimen collection (droplet and contact precautions for URT specimens; airborne precautions for LRT specimens). Maintain proper infection control when collecting specimens
  • Restricted entry to visitors or attendants during sample collection
  • Complete the requisition form for each specimen submitted
  • Proper disposal of all waste generated
Respiratory specimen collection methods:
A. Lower respiratory tract
  • Bronchoalveolar lavage, tracheal aspirate, sputum
  • Collect 2-3 mL into a sterile, leak-proof, screw-cap sputum collection cup or sterile dry container.
B. Upper respiratory tract
  • Nasopharyngeal swab AND oropharyngeal swab
Oropharyngeal swab (e.g. throat swab): Tilt patient’s head back 70 degrees. Rub swab over both tonsillar pillars and posterior oropharynx and avoid touching the tongue, teeth, and gums. Use only synthetic fiber swabs with plastic shafts. Do not use calcium alginate swabs or swabs with wooden shafts. Place swabs immediately into sterile tubes containing 2-3 ml of viral transport media.
Combined nasal & throat swab: Tilt patient’s head back 70 degrees. While gently rotating the swab, insert swab less than one inch into nostril (until resistance is met at turbinates). Rotate the swab several times against nasal wall and repeat in other nostril using the same swab. Place tip of the swab into sterile viral transport media tube and cut off the applicator stick. For throat swab, take a second dry polyester swab, insert into mouth, and swab the posterior pharynx and tonsillar areas (avoid the tongue). Place tip of swab into the same tube and cut off the applicator tip.
Nasopharyngeal swab: Tilt patient’s head back 70 degrees. Insert flexible swab through the nares parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient. Gently, rub and roll the swab. Leave the swab in place for several seconds to absorb secretions before removing.
Clinicians may also collect lower respiratory tract samples when these are readily available (for example, in mechanically ventilated patients). In hospitalized patients in Dedicated Covid Hospitals (severe cases with confirmed COVID – 19 infection, repeat upper respiratory tract samples should be collected to demonstrate viral clearance.
Recommended Test
Real time or Conventional RT-PCR test is recommended for diagnosis. SARS-CoV-2 antibody tests are not recommended for diagnosis of current infection with COVID-19.
Dual infections with other respiratory infections (viral, bacterial and fungal) have been found in COVID-19 patients. Depending on local epidemiology and clinical symptoms, test for other potential etiologies (e.g. Influenza, other respiratory viruses, malaria, dengue fever, typhoid fever) as appropriate.
For COVID-19 patients with severe disease, also collect blood cultures, ideally prior to initiation of antimicrobial therapy

Management of COVID-19: symptomatic treatment

10.1. Management of Mild Cases
In the containment phase, patients with suspected or confirmed mild COVID-19 are being isolated to break the chain of transmission. Patients with mild disease may present to primary care/outpatient department, or detected during community outreach activities, such as home visits or by telemedicine.
Mild cases can be managed at Covid Care Centre, First Referral Units (FRUs), Community Health Centre (CHC), sub-district and district hospitals or at home subject to conditions stipulated in the home isolation guidelines available at
Detailed clinical history is taken including that of co-morbidities. Patient is followed up daily for temperature, vitals and Oxygen saturation (SpO2).
Counsel patients with mild COVID-19 about signs and symptoms of complications that should prompt urgent care. Patients with risk factors for severe illness should be monitored closely, given the possible risk of deterioration. If they develop any worsening symptoms (such as light headedness, difficulty breathing, chest pain, dehydration, etc.), they should be immediately admitted to a Dedicated Covid Health Centre or Dedicated Covid Hospital.
Caregivers of children with mild COVID-19 should monitor for signs and symptoms of clinical deterioration requiring urgent re-evaluation. These include difficulty in breathing/fast or shallow breathing (for infants: grunting, inability to breastfeed), blue lips or face, chest pain or pressure, new confusion, inability to awaken/not interacting when awake, inability to drink or keep down any liquids.
Mild COVID-19 cases may be given symptomatic treatment such as antipyretic (Paracetamol) for fever and pain, adequate nutrition and appropriate rehydration. Tab Hydroxychloroquine (HCQ) may be considered for any of those having high risk features for severe disease (such as age> 60; Hypertension, diabetes, chronic lung/kidney/ liver disease, Cerebrovascular disease and obesity) under strict medical supervision.
10.2. Management of Moderate Cases
Patients with suspected or confirmed moderate COVID-19 (pneumonia) is to be isolated to contain virus transmission. Patients with moderate disease may present to an emergency unit or primary care/outpatient department, or be encountered during community surveillance activities, such as active house to house search or by telemedicine.
The defining clinical assessment parameters are Respiratory Rate of more than or equal to 24 and oxygen saturation (SpO2) of less than 94% on room air (range 90-94%).
Such patients will be isolated in Dedicated Covid Health Centre (DCHC) or District hospital or Medical College hospitals.
The patient will undergo detailed clinical history including co-morbid conditions,
measurement of vital signs, Oxygen saturation (SpO2) and radiological examination of
Chest X-ray, Complete Blood Count and other investigations as indicated.
Antibiotics should not be prescribed routinely unless there is clinical suspicion of a
bacterial infection.
Clinical Management of Moderate cases
Oxygen Support:
  • Target SpO2: 92-96% (88-92% in patients with COPD)
  • The device for administering oxygen (nasal prongs, mask, or masks with breathing / non-rebreathing reservoir bag) depends upon the increasing requirement of oxygen therapy. If HFNC or simple nasal cannula is used, N95 mask should be applied over it.
  • Awake proning may be used as a rescue therapy. (Protocol at Annexure-I)
  • All patients should have daily 12-lead ECG
  • Follow CRP, D-dimer & Ferritin every 48-72 hourly (if available); CBC with differential count, Absolute Lymphocyte count, KFT/LFT daily
  • Tab. Hydroxychloroquine (400mg) BD on 1st day followed by 200mg 1 BD for 4 days. (after ECG Assessment)
  • Consider IV methylprednisolone 0.5 to 1 mg/kg for 3 days (preferably within 48 hours of admission or if oxygen requirement is increasing and if inflammatory markers are increased)
  • Prophylactic dose of UFH or LMWH (e.g., enoxaparin 40 mg per day SC)
  • Control of co-morbid condition
  • Monitor for:
  • Increased work of breathing (use of accessary muscles)
  • Hemodynamic instability
  • Increase in oxygen requirement
If any of the above occurs, shift to Dedicated Covid Hospital
Few patients with COVID-19 experience a secondary bacterial infection. Consider empiric antibiotic therapy as per local antibiogram and guidelines in older people, immune-compromised patients, and children < 5 years of age.
Close monitoring of patients with moderate COVID-19 is required for signs or symptoms of disease progression. Provision of mechanisms for follow up and transportation to Dedicated Covid Hospital should be available.
10.3. Management of Severe Cases
10.3.1 Early supportive therapy and monitoring
a. Give supplemental oxygen therapy immediately to patients with Severe Covid and respiratory distress, hypoxaemia, or shock: Initiate oxygen therapy at 5 L/min and titrate flow rates to reach target SpO2 ≥ 90% in non-pregnant adults and SpO2 ≥ 92- 96% in pregnant patients. Children with emergency signs (obstructed or absent breathing, severe respiratory distress, central cyanosis, shock, coma or convulsions) should receive oxygen therapy during resuscitation to target SpO2≥94%. All areas where patients with Severe Covid are cared for should be equipped with pulse oximeters, functioning oxygen systems and disposable, singleuse, oxygen delivering interfaces (nasal cannula, simple face mask, and mask with reservoir bag). Use contact precautions when handling contaminated oxygen interfaces of patients with COVID – 19.
b. Use conservative fluid management in patients with Severe Covid when there is no evidence of shock.
10.3.2 Management of hypoxemic respiratory failure and ARDS
Recognize severe hypoxemic respiratory failure when a patient with respiratory distress is failing standard oxygen therapy. Patients may continue to have increased work of breathing or hypoxemia even when oxygen is delivered via a face mask with reservoir bag (flow rates of 10-15 L/min, which is typically the minimum flow required to maintain bag inflation; FiO2 0.60-0.95). Hypoxemic respiratory failure in ARDS commonly results from intrapulmonary ventilationperfusion mismatch or shunt and usually requires mechanical ventilation.
High – Flow Nasal Cannula oxygenation (HFNO) or non – invasive mechanical ventilation:
When respiratory distress and/or hypoxemia of the patient cannot be alleviated after receiving standard oxygen therapy, high – flow nasal cannula oxygen therapy or non – invasive ventilation can be considered. Compared to standard oxygen therapy, HFNO reduces the need for intubation. Patients with hypercapnia (exacerbation of obstructive lung disease, cardiogenic pulmonary oedema), hemodynamic instability, multi-organ failure, or abnormal mental status should generally not receive HFNO, although emerging data suggest that HFNO may be safe in patients with mildmoderate and non worsening hypercapnia. Patients receiving HFNO should be in a monitored setting and cared for by experienced personnel capable of endotracheal intubation in case the patient acutely deteriorates or does not improve after a short trial (about 1 hr).
There has been concerns raised about generation of aerosols while using HFNO and NIV. However, recent publications suggest that newer HFNO and NIV systems with good interface fitting do not create widespread dispersion of exhaled air and therefore should be associated with low risk of airborne transmission. If conditions do not improve or even get worse within a short time (1 – 2 hours), tracheal intubation and invasive mechanical ventilation should be used in a timely manner.
  • Endotracheal intubation should be performed by a trained and experienced provider using airborne precautions. Patients with ARDS, especially young children or those who are obese or pregnant, may de-saturate quickly during intubation. Pre-oxygenate with 100% FiO2 for 5 minutes, via a face mask with reservoir bag, bag-valve mask, HFNO, or NIV. Rapid sequence intubation is appropriate after an airway assessment that identifies no signs of difficult intubation.
  • Implement mechanical ventilation using lower tidal volumes (4–8 ml/kg predicted body weight, PBW) and lower inspiratory pressures (plateau pressure <30 cmH2O). This is a strong recommendation from a clinical guideline for patients with ARDS, and is suggested for patients with sepsis-induced respiratory failure. The initial tidal volume is 6 ml/kg PBW; tidal volume up to 8 ml/kg PBW is allowed if undesirable side effects occur (e.g. dys-synchrony, pH <7.15). Hypercapnia is permitted if meeting the pH goal of 7.30-7.45. Ventilator protocols are available. The use of deep sedation may be required to control respiratory drive and achieve tidal volume targets.
  • In patients with severe ARDS, prone ventilation for 16-18 hours per day is recommended but requires sufficient human resources and expertise to be performed safely. (Refer to Annexure-I)
  • In patients with moderate or severe ARDS, higher PEEP instead of lower PEEP is suggested. PEEP titration requires consideration of benefits (reducing atelectrauma and improving alveolar recruitment) vs. risks (end-inspiratory overdistension leading to lung injury and higher pulmonary vascular resistance). Tables are available to guide PEEP titration based on the FiO2 required to maintain SpO2. In patients with moderate-severe ARDS (PaO2/FiO2<150), neuromuscular blockade by continuous infusion should not be routinely used.
  • In settings with access to expertise in extracorporeal life support (ECLS), consider referral of patients with refractory hypoxemia despite lung protective ventilation. ECLS should only be offered in expert centres with a sufficient case volume to maintain expertise and that can apply the IPC measures required for COVID – 19 patients.
  • Avoid disconnecting the patient from the ventilator, which results in loss of PEEP and atelectasis. Use in-line catheters for airway suctioning and clamp endotracheal tube when disconnection is required (for example, transfer to a transport ventilator).
Source: MoHFW

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