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For those among us that are hardcore fans of not only Apple products, but also the software and mobile applications that they make, I am pretty sure you paid close attention to the announcements made during the recent media event in San Francisco. The public and media focus centered predominately around the fact that Apple were launching a new and improved Apple TV as well as the all new iPad, both of which are set for public release a week from today.
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Convalescent Plasma (PDF): A new recommendation was developed against the routine use of convalescent plasma among immunocompromised patients hospitalized with COVID-19. Additionally, this section includes updated remarks for the existing recommendation on the use of convalescent plasma for ambulatory patients with mild-to-moderate COVID-19 at high risk for progression to severe disease who have no other treatment options.
Critical and important outcomes for decision-making varied across populations/groups. For example, among hospitalized patients (at any disease severity), critical outcomes included mortality, need for invasive mechanical ventilation, duration of hospitalization, failure of clinical improvement, adverse events, and serious adverse events. Among ambulatory populations with COVID-19 infection, the outcome of hospitalization replaced duration of hospitalization. Among persons receiving pre- or post-exposure prophylaxis, outcomes included measures of symptomatic COVID-19 infection.
Five RCTs showed a trend toward mortality among patients with COVID-19 treated with HCQ compared to those who were not (relative risk [RR]: 1.08; 95% confidence interval [CI]: 0.99, 1.19, Moderate certainty in the evidence) (Table 1) [28, 29, 33].
One RCT could not exclude the risk of in-hospital mortality among patients treated with HCQ+AZ compared to those not receiving HCQ or HCQ+AZ (hazard ratio [HR]: 0.64; 95% CI: 0.18, 2.21; Low certainty of evidence [CoE]) [28]. Three non-randomized studies failed to identify an association between treatment with HCQ+AZ and mortality: Ip reported an adjusted HR of 0.98 (95% CI: 0.75, 1.28); Magagnoli reported an adjusted HR in a subset after propensity score adjustment of 0.89 (95% CI: 0.45, 1.77); Rosenberg 2020 reported an adjusted HR of 1.35 (95% CI: 0.79, 2.40) [37, 39, 41]. As stated in the HCQ section, one non-randomized study reported a reduction in mortality among patients receiving HCQ+AZ (HR: 0.29; 95% CI: 0.22, 0.40); however, it failed to adjust for the critical confounder of disease severity and imbalances in steroid use [27]. As described in the HCQ section, similar methodologic concerns exist among patients allocated to HCQ+AZ in the Arshad study, leading to several sources of bias in interpreting their favorable results.
One RCT reported that persons treated with HCQ experienced a longer time until hospital discharge (median 16 days compared with 13 days) and lower probability of being discharged alive within the 28-day study period (rate ratio: 0.92; 95% CI: 0.85, 0.99) [29]. In addition, persons treated with HCQ who were not on mechanical ventilation at baseline were more likely to be placed on mechanical ventilation during follow up (rate ratio: 1.10; 95% CI: 0.92, 1.31; Low CoE) [29, 32]. Across the body of evidence from four RCTs, treatment with HCQ may increase the risk of experiencing adverse events (RR: 2.36; 95% CI: 1.49, 3.75; Low CoE) and severe adverse events (adjusted odds ratio: 1.26; 95% CI: 0.56, 2.84; Low CoE) [28, 30, 31, 35]. One RCT and two non-randomized studies suggest increased risk of QT prolongation among patients treated with HCQ compared to those not receiving HCQ (RR: 8.47; 95% CI: 1.14, 63.03; Low CoE and RR: 2.89; 95% CI: 1.62, 5.16; Very low CoE, respectively) [28, 38, 39]. In addition, Rosenberg 2020 reported 16% of patients in the HCQ arm experienced arrhythmias compared with 10% in the non-HCQ arm (RR: 1.56; 95% CI: 0.97, 2.50; Very low CoE).
One RCT suggests increased risk of QT prolongation among patients treated with HCQ+AZ compared to those not receiving HCQ (RR: 8.50; 95% CI: 1.16, 62.31; Low CoE) [28]. Two studies described significant QT prolongation in 10 of 95 patients treated with HCQ+AZ, illustrating the high risk for clinically relevant arrhythmias with this treatment [43, 45]. In addition, several case reports of QT prolongation related to HCQ have also been published [53-56]. A case-control study of persons with COVID-19 treated with HCQ+AZ compared to healthy, untreated controls reported higher values of minimum (415 vs. 376 ms), mean (453 vs. 407 ms) and maximum QTc-interval (533 vs. 452 ms) among COVID-19 cases (n=22) compared to controls (n=34) [42].
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One RCT reported on post-exposure prophylaxis with combination lopinavir/ritonavir or placebo for ambulatory persons exposed to COVID-19 [69]. During the follow up period of 21 days, the investigators reported on symptomatic SARS-CoV-2 infection (COVID) either independent of baseline PCR/serology or among those who had a negative PCR test/serology at baseline.
Among persons exposed to COVID-19, prophylactic treatment with lopinavir/ritonavir failed to show or exclude a beneficial effect on symptomatic SARS-CoV-2 infection, either independent of baseline PCR/serology or among those with a negative PCR and serology at baseline (HR: 0.60; 95% CI: 0.29, 1.26; moderate CoE and HR: 0.59; 95% CI: 0.17, 2.02; moderate CoE, respectively).
Our search identified one systematic review that analyzed eight RCTs reporting on treatment with glucocorticoids among 1,844 critically ill patients with COVID-19 [79]. Three RCTs reported on patients treated with low- and high-dose dexamethasone [78, 80, 81]; three RCTs reported on patients treated with low-dose hydrocortisone [82-84]; and two RCTs reported on patients treated with high-dose methylprednisolone [79, 85]. The definition of critically ill varied across trials; however, the majority of patients had ARDS.
The RECOVERY trial is a randomized trial among hospitalized patients in the United Kingdom [80]. In that study, 2,104 participants were randomized to receive dexamethasone (6 mg daily for up to 10 days) and 4,321 were randomized to usual care. The RECOVERY trial reported on the outcomes of mortality and hospital discharge. Participants and study staff were not blinded to the treatment arms.
Among hospitalized, critically ill patients, the odds of mortality at 28 days was 34% less among patients treated with glucocorticoids than among patients not treated with glucocorticoids (OR: 0.66; 95% CI: 0.54; 0.82; high CoE). In addition, at 28 days, patients receiving dexamethasone were more likely to be discharged from the hospital (RR: 1.11; 95% CI: 1.04, 1.19; moderate CoE).
A systematic review of six studies did not report a difference in the events of serious adverse events experienced by patients randomized to receive treatment with glucocorticoids or no treatment with glucocorticoids (64/354 among those receiving glucocorticoids versus 80/342 among those not receiving glucocorticoids).
Serious adverse events may be more frequent among patients with mild-to-moderate disease receiving treatment with inhaled corticosteroids rather than no inhaled corticosteroids; however, this may not be meaningfully different from those not receiving inhaled corticosteroids (RR: 1.14; 95% CI: 0.32, 3.99; moderate CoE).
Serious adverse events among patients receiving tocilizumab or sarilumab did not differ from those receiving usual care (RR: 0.89; 95% CI: 0.74, 1.07; low CoE and RR: 1.03; 95% CI: 0.89, 1.18; low CoE, respectively). An additional trial attributed treatment with tocilizumab to three serious adverse events; however, did not report events among patients not receiving tocilizumab [111]. Previously, tocilizumab has been associated with gastrointestinal perforations in non-COVID-19 settings, and case reports of bowel perforations have recently emerged with the use of tocilizumab for COVID-19 [120-123]. Increased infection risks have been noted in uncontrolled studies, and it is possible that this risk may be compounded by the combination of glucocorticoids and tocilizumab. [124, 125].
The use of tocilizumab, as with other therapeutic agents that can suppress the immune system, presents additional considerations and potential concerns when used in immunocompromised hosts. The panel did not conduct an analysis of available data to assess differences in efficacy and/or adverse effects of tocilizumab among oncology or other immunocompromised patients at this time.
Updated analyses include the final analysis from the ACTT-1 and the interim analysis of the SOLIDARITY trial [32, 157]. SOLIDARITY reported mortality among persons remaining in hospital up to the duration of the study; however, among patients discharged before the end of the study, mortality may not have been collected completely. The study by Wang et al (2020) was stopped early due to lack of recruitment into the trial due to decreased incidence in China.
Randomization performed in Goldman 2020 failed to establish prognostic balance between baseline clinical status among the 397 patients randomized into the treatment arms, with patients in the 10-day arm more severely ill at study entry. Even with the adjusted analysis, residual confounding is possible. In addition, participants, healthcare workers, and outcome assessors were not blinded to the treatment arms.
Subgroups from SOLIDARITY and ACTT-1 reported on the outcomes of mortality, time to recovery and serious adverse events among patients on invasive ventilation or ECMO [32, 157] (Table 17b). The duration of ventilation at time of treatment with remdesivir was not reported in ACTT-1. This may introduce uncertainty when assessing outcomes of mortality or time to recovery.