ICMR: Revised Guidelines on Clinical Management of COVID-19

Revised Guidelines on Clinical Management of COVID-19 

This document published on 31st March, 2021 is intended for clinicians taking care of hospitalised adult and paediatric patients of COVID-19. It is not meant to replace clinical judgment or specialist consultation but rather to strengthen clinical management of these patients and provide to up-to-date guidance. Best practices for COVID-19 including IPC and optimized supportive care for severely ill patients as considered essential. This document aims to provide clinicians with updated interim guidance on timely, effective, and safe supportive management of patients with COVID-19, particularly those with severe acute respiratory illness and critically ill.

1. Case definition

When to suspect

• All symptomatic individuals who have undertaken international travel in the last 14 days or

• All symptomatic contacts of laboratory confirmed cases or

• All symptomatic healthcare personnel (HCP) or

• All hospitalized patients with severe acute respiratory illness ( SARI) (fever AND cough and/or shortness of breath) or

• Asymptomatic direct and high risk contacts of a confirmed case (should be tested once between day 5 and day 14 after contact)

Symptomatic refers to fever/cough/shortness of breath.

Direct and high-risk contacts include those who live in the same household with a confirmed 

case and HCP who examined a confirmed case.

Confirmed case

A person with laboratory confirmation of COVID-19 infection, irrespective of clinical signs and symptoms.

2. Clinical features

COVID-19 may present with mild, moderate, or severe illness; the latter includes severe pneumonia, ARDS, sepsis and septic shock. Early recognition of suspected patients allows for timely initiation of IPC (see Table 1). Early identification of those with severe manifestations allows for immediate optimized supportive care treatments and safe, rapid admission to intensive care unit .

Clinical syndromes associated with COVID-19 infection

Uncomplicated illness

Patients with uncomplicated upper respiratory tract viral infection, may have non-specific symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache. The elderly and immunosuppressed may present withatypical symptoms.

Mild pneumonia

Patient with pneumonia and no signs of severe pneumonia.Child with non-severe pneumonia has cough or difficulty in breathing/ fast breathing: (fast breathing - in breaths/min): <2 months, ≥60; 2–11 months, ≥50; 1–5 years, ≥40 and no signs of severe pneumonia

Severe pneumonia

Adolescent or adult: fever or suspected respiratory infection, plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air. Child with cough or difficulty in breathing, plus at least one of the following: central cyanosis or SpO2 <90%; severe respiratory distress (e.g. grunting, chest in-drawing); signs of pneumonia with any of the following danger signs: inability to breastfeed or drink, lethargy or unconsciousness, or convulsions. Other signs of pneumonia may be present: chest indrawing, fast breathing (in breaths/min): <2  months ≥60; 2–11 months ≥50; 1–5 years ≥40. The diagnosis is clinical; chest imaging can exclude complications.

Acute Respiratory DistressSyndrome

Onset: new or worsening respiratory symptoms within one week of known clinical insult. Chest imaging (radiograph, CT scan, or lung ultrasound): bilateral opacities, not fully explained by effusions, lobar or lung collapse, or nodules.

Origin of oedema: respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (e.g. echocardiography) to exclude hydrostatic 

cause of oedema if no risk factor present.

Oxygenation (adults):

• Mild ARDS: 200 mmHg < PaO2/FiO2 ≤ 300 mmHg (with PEEP or CPAP ≥5cm H2O, or non-ventilated)

• Moderate ARDS: 100 mmHg < PaO2/FiO2 ≤200 mmHg with PEEP ≥5 cm H2O, or non-ventilated)

• Severe ARDS: PaO2/FiO2 ≤ 100 mmHg with PEEP ≥5 cm H2O, or non-ventilated)

• When PaO2 is not available, SpO2/FiO2 ≤315 suggests ARDS (including innon ventilated patients) 

Oxygenation (children; note OI = Oxygenation Index and OSI Oxygenation Index using SpO2)

• Bilevel NIV or CPAP ≥5 cm H2O via full face mask: PaO2/FiO2 ≤ 300 mmHg or SpO2/FiO2 ≤264

• Mild ARDS (invasively ventilated): 4 ≤ OI < 8 or 5 ≤ OSI < 7.5

• Moderate ARDS (invasively ventilated): 8 ≤ OI < 16 or 7.5 ≤ OSI < 12.3

• Severe ARDS (invasively ventilated): OI ≥ 16 or OSI ≥ 12.3

Sepsis

Adults: life-threatening organ dysfunction caused by a dysregulated host response to suspected or proven infection, with organ dysfunction. Signs of organ dysfunction include: altered mental status, difficult or fast breathing, low oxygen saturation, reduced urine output, fast heart rate, weak pulse, cold extremities or low blood pressure, skin mottling, or laboratory evidence of coagulopathy, thrombocytopenia, acidosis, high lactate or hyperbilirubinemia.

Children: suspected or proven infection and ≥2 SIRS criteria, of which one must be

abnormal temperature or white blood cell count.

Septic Shock

Adults: Persisting hypotension despiteo volume resuscitation, requiring vasopressors to maintain MAP ≥65 mmHg and serum lactate level < 2 mmol/L.

Children: any hypotension (SBP <5th centile or >2 SD below normal for age) or 2-

3 of the following: altered mental state; bradycardia or tachycardia (HR <90 bpm or >160 bpm in infants and HR <70 bpm or >150 bpm in children); prolonged capillary refill (>2 sec) or warm vasodilation with bounding pulses; tachypnea; mottled skin or petechial or purpuric rash; increased lactate; oliguria; hyperthermia or hypothermia.

3. Immediate implementation of appropriate IPC measures

Infection prevention control (IPC) is a critical and integral part of clinical management of patients and should be initiated at the point of entry of the patient to hospital (typically the Emergency Department). Standard precautions should always be routinely applied in all areas of health care facilities. Standard precautions include hand hygiene; use of PPE to avoid direct contact with patients’ blood, body fluids, secretions (including respiratory secretions) and non-intact skin. Standard precautions also include prevention of needle-stick or sharps injury; safe waste management; cleaning and disinfection of equipment; and cleaning of the environment.

How to implement infection prevention and control measures for patients with suspected or confirmed COVID-19 infection?

At triage

Give suspect patient a triple layer surgical mask and direct patient to separate area, an isolation room if available. Keep at least 1meter distance between suspected patients and other patients. Instruct all patients to cover nose and mouth during coughing or sneezing with tissue or flexed elbow for others. Perform hand hygiene after contact with respiratory secretions.

Apply droplet precautions

Droplet precautions prevent large droplet transmission of respiratory viruses. Use a triple layer surgical mask if working within 1-2 metres of the patient. Place patients in single rooms, or group together those with the same etiological diagnosis. If an etiological diagnosis is not possible, group patients with similar clinical diagnosis and based on epidemiological risk factors, with a spatial separation. When providing care in close contact with a patient with respiratory symptoms (e.g. coughing or sneezing), use eye protection (face-mask or goggles), because sprays of secretions may occur. Limit patient movement within the institution and ensure that patients wear triple layer surgical masks when outside their rooms.

Apply contact precautions

Droplet and contact precautions prevent direct or indirect transmission from contact with contaminated surfaces or equipment (i.e. contact with contaminated oxygen tubing/interfaces). Use PPE (triple layer surgical mask, eye protection, gloves and gown) when entering room and remove PPE when leaving. If possible, use either disposable or dedicated equipment (e.g. stethoscopes, blood pressure cuffs and thermometers). If equipment needs to be shared among patients, clean and disinfect between each patient use. Ensure that health care workers refrain from touching their eyes, nose, and mouth with potentially contaminated gloved or ungloved hands. Avoid contaminating environmental surfaces that are not directly related to patient care (e.g. door handles and light switches). Ensure adequate room ventilation. Avoid movement of patients or transport. Perform hand hygiene.

Apply airborne precautions when performing an aerosol generating procedure

Ensure that healthcare workers performing aerosol-generating procedures (i.e. open suctioning of respiratory tract, intubation, bronchoscopy, cardiopulmonary resuscitation) use PPE, including gloves, long-sleeved gowns, eye protection, and fit-tested particulate respirators (N95). (The scheduled fit test should not be confused with user seal check before each use.) Whenever possible, use adequately ventilated single rooms when performing aerosol-generating procedures, meaning negative pressure rooms with minimum of 12 air changes per hour or at least 160 litres/second/patient in facilities with natural ventilation. Avoid the presence of unnecessary individuals in the room. Care for the patient in the same type of room after mechanical ventilation commences.

Abbreviations: ARI, acute respiratory infection; PPE, personal protective equipment

4. Laboratory diagnosis

Guidance on specimen collection, processing, transportation, including related biosafety procedures, is available on https://mohfw.gov.in/media/disease-alerts. As per directive from MoHFW, Government of India, all suspected cases are to be reported to district and state surveillance officers.

Helpline for COVID-19 (MOHFW, GOI)

Sample collection:

Preferred sample: Throat and nasal swab in viral transport media (VTM) and transported on ice 

Alternate: Nasopharyngeal swab, BAL or endotracheal aspirate which has to be mixed with the viral transport medium and transported on ice.

General guidelines:

• Trained health care professionals to wear appropriate PPE with latex free purple nitrile gloves while collecting the sample from the patient. 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 fiberswabs 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 with confirmed  COVID-19 infection, repeat upper respiratory tract samples should be collected to demonstrate viral clearance.

5. Early supportive therapy and monitoring

a Give supplemental oxygen therapy immediately to patients with SARI and respiratory distress, hypoxaemia, or shock: Initiate oxygen therapy at 5 L/min and titrate flow rates to reach target SpO2 290% in non-pregnant adults and SpO2>92-95 % 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%; otherwise, the target SpO2 is 290%. All areas where patients with SARI are cared for should be equipped with pulse oximeters, functioning oxygen systems and disposable, single-use, 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 SARI when there is no evidence of shock: Patients with SARI should be treated cautiously with intravenous fluids, because aggressive fluid resuscitation may worsen oxygenation, especially in settings where there is limited availability of mechanical ventilation.

c. Give empiric antimicrobials to treat all likely pathogens causing SARI. Give antimicrobials within one hour of initial patient assessment for patients with sepsis: Although the patient may be suspected to have COVID-19, Administer appropriate empiric antimicrobials within ONE hour of identification of sepsis. Empirical antibiotic treatment should be based on the clinical diagnosis (community-acquired pneumonia, health care-associated pneumonia [if infection was acquired in healthcare setting], or sepsis), local epidemiology and susceptibility data, and treatment guidelines. Empirical therapy includes a neuraminidase inhibitor for treatment of influenza when there is local circulation or other risk factors, including travel history or exposure to animal influenza viruses. Empirical therapy should be de-escalated on the basis

of microbiology results and clinical judgment.

d Do not routinely give systemic corticosteroids for treatment of viral pneumonia or ARDS outside of clinical trials unless they are indicated for another reason: A systematic review of observational studies of corticosteroids administered to patients with SARS reported no survival benefit and possible harms (avascular necrosis, psychosis, diabetes, and delayed viral clearance). A systematic review of observational studies in influenza found a higher risk of mortality and secondary infections with corticosteroids; the evidence was judged as very low to low quality due to confounding by indication. A subsequent study that addressed this limitation by adjusting for time-varying confounders found no effect on mortality. Finally, a recent study of patients receiving corticosteroids for MERS used a similar statistical approach  and found no effect of corticosteroids on mortality but delayed lower respiratory tract (LRT) clearance of MERS-CoV. Given lack of effectiveness and possible harm, routine corticosteroids should be avoided unless they are indicated for another reason. See section F for the use of corticosteroids in sepsis.

e. Closely monitor patients with SARI for signs of clinical deterioration, such as rapidly progressive respiratory failure and sepsis, and apply supportive care interventions immediately: Application of timely, effective, and safe supportive therapies is the cornerstone of therapy for patients that develop severe manifestations of COVID-19.

f. Understand the patient’s co-morbid condition(s) to tailor the management of critical illness and appreciate the prognosis: During intensive care management of SARI, determine which chronic therapies should be continued and which therapies should be stopped temporarily.

g. Communicate early with patient and family: Communicate pro-actively with patients and families and provide support and prognostic information. Understand the patient’s values and preferences regarding life-sustaining interventions.

6. Specific therapy

NO SPECIFIC ANTIVIRALS have been proven to be effective as per currently available data. However, based on the available information (uncontrolled clinical trials), the following drugs may be considered as an off – label indication in patients with severe disease and requiring ICU management: 

• Hydroxychloroquine (Dose 400mg BD – for 1 day followed by 200mg BD for 4 days) 

In combination with

• Azithromycin (500 mg OD for 5 days) 

These drugs should be administered under close medical supervision, with monitoring for side effects including QTc interval. The above medication is presently not recommended for children less than 12 years, pregnant and lactating women.

 

These guidelines are based on currently available information and would be reviewed from time to time as new evidence emerges. 

Support to Treating Physicians: AIIMS, New Delhi is running a 24x7 helpline to provide support to the treating physicians on clinical management. The helpline number is 9971876591. The identified nodal doctor of the State, appointed for clinical management of COVID-19 should only contact AIIMS Call Centre.