⚠️Breaking GOOD NEWS on remdesivir: In cohort of patients hospitalized for severe #Covid19 treated with compassionate-use remdesivir, clinical improvement observed in 36/53 patients (68%). Hopeful findings. Will still require a randomized trial. #COVID19 nejm.org/doi/full/10.10…
2) “median follow-up 18 days, 36 patients (68%) improvement in oxygen-support class, incl 17/30 patients (57%) mechanical ventilation who were extubated. 25 patients (47%) discharged, 7 (13%) died; mortality was 18% (6/34) in invasive vent; and 5% (1/19) among no vent. #COVID19
3) “By way of comparison, the 13% mortality observed in this remdesivir compassionate-use cohort is noteworthy, considering the severity of disease in this patient population”
4) “For example, among 201 patients hospitalized in Wuhan, China, mortality was 22% overall and 66% (44 of 67) among patients receiving invasive mechanical ventilation.” #COVID19
5) “In case series and cohort studies, largely from China, mortality rates of 17 to 78% have been reported in severe cases, defined by the need for admission to an intensive care unit, invasive ventilation, or both.” #COVID19
6) In the current NEJM study: “Specifically, improvement in oxygen-support was seen in 68%, and overall mortality was 13% over a median follow-up of 18 days.” And in “recent randomized trial of lopinavir–ritonavir in patients hospitalized for #Covid19, 28-day mortality was 22%.”
7) “Unfortunately, our compassionate-use program did not collect viral load data to confirm the antiviral effects of remdesivir or any association between baseline viral load and viral suppression, if any, and clinical response.” #COVID19
8) “the duration of remdesivir therapy was not entirely uniform in our study, largely because clinical improvement enabled discharge from the hospital. The effectiveness of a shorter duration of therapy (e.g., 5 days, as compared with 10 days) [will be assessed more]” #COVID19
9) “No new safety signals were detected during short-term remdesivir therapy in this compassionate-use cohort. Nonclinical toxicology studies show renal abnormalities, but no clear evidence of nephrotoxicity... was observed.” But placebo controlled trial still needed. #COVID19
10) “Interpretation of results of study is limited by small size of cohort, relatively short duration of follow-up, potential missing data owing to nature of program, the lack of info on 8 of the patients initially treated, and the lack of randomized control group.” #COVID19
11) “Although [not definitive cuz not trial], comparisons with contemporaneous cohorts from the literature, in whom general care is expected to be consistent with that of our cohort, suggest that 📌remdesivir may have clinical benefit in patients with severe Covid-19.” #COVID19
12) ➡️BOTTOMLINE: Results are indeed hopeful and promising from this uncontrolled remdesivir intervention study. But again, “The findings will be informed by the ongoing randomized, placebo-controlled trials of remdesivir therapy for #Covid19”. TRIALS TRIALS TRIALS PLEASE.
