IDSA's updated guidelines on COVID-19 released
IDSA
Infectious Disease Society of America (IDSA) has been releasing new approach and recommendation for managing COVID-19 at regular intervals. It has now released new updates on the treatment and management of patients with COVID-19.
New updates of Infectious Disease Society of America (IDSA) guidelines include recommendations on the routine use of lopinavir/ritonavir, tocilizumab, and remdesivir. It also includes a new recommendation for the use of Bamlanivimab. The updated versions were released on 18/11/2020 and 22/11/2020.
With regards to lopinavir/ritonavir the IDSA guideline panel strongly recommended against the use of the combination lopinavir-ritonavir.
The guideline panel stated "Among hospitalized patients with COVID-19, the IDSA guideline panel recommends against the use of the combination lopinavir/ritonavir. (Strong recommendation, Moderate certainty of evidence)"
The guideline panel recommended this based on the evidence from three clinical trials which showed outcomes such as mortality, failure of clinical improvement, need for mechanical ventilation, and adverse events leading to treatment discontinuation.
RECOVERY trial reported 1/1588 serious adverse event due to treatment with lopinavir-ritonavir and nearly 14% of lopinavir-ritonavir recipients in Cao 2020 trial were unable to complete the full 14-day course of administration due to adverse reaction especially related to GI disturbances. The side-effect profile observed in these trials raise concerns about the use of higher or more prolonged lopinavir-ritonavir dose regimens in efforts to improve outcomes.
With regards to tocilizumab the guideline panel also suggests against its routine use. unlike lopinavir-ritonavir the recommendation was conditional.
"Among patients who have been admitted to the hospital with COVID-19, the IDSA guideline panel suggests against the routine use of tocilizumab. (Conditional recommendation, low certainty of evidence)" the guideline panel stated.
Based on the results of five Randomized Control clinical trial tocilizumab failed to show a beneficial effect on 28-day mortality compared to no tocilizumab treatment. Researchers also found tocilizumab demonstrated a lower relative risk of clinical deterioration, defined as death, need for mechanical ventilation, or ICU admission, compared to placebo/usual care. Serious adverse events among patients receiving tocilizumab did not differ from those not receiving tocilizumab.
When healthcare personnel and outcome assessors were blinding in the included trials, the panel noted that tocilizumab causes visible reduction in C-reactive protein (CRP) levels, which would reveal the treatment arm designations of the patients; therefore, introducing bias for the more subjectively measured outcomes of clinical deterioration and serious adverse events.
So the guideline panel concluded that further research is needed in such a way to minimise the bias and achieve the generalizability of tocilizumab with different interleukin-6 receptor inhibitors for patients with COVID-19.
For remdesivir the guideline panel also suggests against its routine use. Following are the recommendations of the panel:
1. In hospitalized patients with severe* COVID-19, the IDSA panel suggests remdesivir over no antiviral treatment. (Conditional recommendation, Moderate certainty of evidence)
2. In patients on supplemental oxygen but not on mechanical ventilation or ECMO, the IDSA panel suggests treatment with five days of remdesivir rather than 10 days of remdesivir. (Conditional recommendation, Low certainty of evidence)
3. In patients with COVID-19 admitted to the hospital without the need for supplemental oxygen and oxygen saturation >94% on room air, the IDSA panel suggests against the routine use of remdesivir. (Conditional recommendation, Very low certainty of evidence)
The guideline panel concluded stating "The guideline panel suggests against remdesivir for routine treatment of patients with oxygen saturation >94% and no supplemental oxygen; however, strongly urges continued study through recruitment into RCT"
However, the panel suggests remdesivir for treatment of severe COVID-19 in hospitalized patients with SpO2 <94% on room air, including patients on supplemental oxygen, on mechanical ventilation and ECMO.
" Additional clinical trials are needed to provide increased certainty about the potential for both benefit and harms of treatment with remdesivir, as well as understand the benefit of treatment based on disease severity" the guideline panel further added.
For bamlanivimab: the guideline panel advises against the use of bamlanivimab among ambulatory patients with COVID-19.
"Among ambulatory patients with COVID-19, the IDSA guideline panel suggests against the routine use of bamlanivimab. (Conditional recommendation, Very low certainty of evidence)"
The guideline panel suggests this recommendation because it recognised participants in clinical trial including those at increased risk of progressing to severe COVID-19 (as defined by the FDA EUA [131]) were placed under a higher value on the uncertain benefits and a low value on the uncertain adverse events. It further suggests trial participants, to reasonably select the treatment after careful discussion with their clinician.
"The guideline panel recognized the need for continued research and accrual of evidence, particularly trials on patient important outcomes in existing and new monoclonal antibodies" the guideline panel concluded.
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