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0 0.5 1 1.5 2+ Death/hospitalization 87% primary Improvement Relative Risk Hospitalization 72% Recovery 29% Recovery (b) 48% Remdesivir  PINETREE  EARLY TREATMENT  DB RCT Is early treatment with remdesivir beneficial for COVID-19? Double-blind RCT 562 patients in multiple countries (Sep 2020 - Apr 2021) Lower death/hosp. (p=0.008) and hospitalization (p=0.0092) Gottlieb et al., New England J. Medicine, Dec 2021 Favors remdesivir Favors control

Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients

Gottlieb et al., New England Journal of Medicine, doi:10.1056/NEJMoa2116846, PINETREE, NCT04501952
Dec 2021  
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RCT high-risk outpatients, 279 treated with remdesivir and 283 control patients, median 5 days from symptoms, showing significantly lower hospitalization with treatment.
Gérard, Wu, Zhou show significantly increased risk of acute kidney injury with remdesivir.
risk of death/hospitalization, 87.0% lower, RR 0.13, p = 0.008, treatment 2 of 279 (0.7%), control 15 of 283 (5.3%), NNT 22, adjusted per study, COVID-19 related hospitalization or death from any cause @day 28, primary outcome.
risk of hospitalization, 71.8% lower, RR 0.28, p = 0.009, treatment 5 of 279 (1.8%), control 18 of 283 (6.4%), NNT 22.
risk of no recovery, 29.1% lower, RR 0.71, p = 0.31, treatment 43 of 66 (65.2%), control 45 of 60 (75.0%), adjusted per study, inverted to make RR<1 favor treatment, alleviation of symptoms @day 14.
risk of no recovery, 47.9% lower, RR 0.52, p = 0.003, treatment 108 of 169 (63.9%), control 132 of 165 (80.0%), NNT 6.2, adjusted per study, inverted to make RR<1 favor treatment, post-hoc alleviation of symptoms @day 14.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Gottlieb et al., 22 Dec 2021, Double Blind Randomized Controlled Trial, multiple countries, peer-reviewed, 30 authors, study period 18 September, 2020 - 8 April, 2021, average treatment delay 5.0 days, trial NCT04501952 (history) (PINETREE).
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This PaperRemdesivirAll
Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients
Robert L Gottlieb, Carlos E Vaca, Roger Paredes, Jorge Mera, Brandon J Webb, Gilberto Perez, Godson Oguchi, Pablo Ryan, Bibi U Nielsen, Michael Brown, Ausberto Hidalgo, Yessica Sachdeva, Shilpi Mittal, Olayemi Osiyemi, Jacek Skarbinski, Kavita Juneja, Robert H Hyland, Anu Osinusi, Shuguang Chen, Gregory Camus, Mazin Abdelghany, Santosh Davies, Nicole Behenna-Renton, Frank Duff, Francisco M Marty, Morgan J Katz, Adit A Ginde, Samuel M Brown, Joshua T Schiffer, Joshua A Hill
New England Journal of Medicine, doi:10.1056/nejmoa2116846
BACKGROUND Remdesivir improves clinical outcomes in patients hospitalized with moderate-tosevere coronavirus disease 2019 (Covid-19). Whether the use of remdesivir in symptomatic, nonhospitalized patients with Covid-19 who are at high risk for disease progression prevents hospitalization is uncertain. METHODS We conducted a randomized, double-blind, placebo-controlled trial involving nonhospitalized patients with Covid-19 who had symptom onset within the previous 7 days and who had at least one risk factor for disease progression (age ≥60 years, obesity, or certain coexisting medical conditions). Patients were randomly assigned to receive intravenous remdesivir (200 mg on day 1 and 100 mg on days 2 and 3) or placebo. The primary efficacy end point was a composite of Covid-19related hospitalization or death from any cause by day 28. The primary safety end point was any adverse event. A secondary end point was a composite of a Covid-19related medically attended visit or death from any cause by day 28. RESULTS A total of 562 patients who underwent randomization and received at least one dose of remdesivir or placebo were included in the analyses: 279 patients in the remdesivir group and 283 in the placebo group. The mean age was 50 years, 47.9% of the patients were women, and 41.8% were Hispanic or Latinx. The most common coexisting conditions were diabetes mellitus (61.6%), obesity (55.2%), and hypertension (47.7%). Covid-19-related hospitalization or death from any cause occurred in 2 patients (0.7%) in the remdesivir group and in 15 (5.3%) in the placebo group (hazard ratio, 0.13; 95% confidence interval [CI], 0.03 to 0.59; P = 0.008). A total of 4 of 246 patients (1.6%) in the remdesivir group and 21 of 252 (8.3%) in the placebo group had a Covid-19-related medically attended visit by day 28 (hazard ratio, 0.19; 95% CI, 0.07 to 0.56). No patients had died by day 28. Adverse events occurred in 42.3% of the patients in the remdesivir group and in 46.3% of those in the placebo group. CONCLUSIONS Among nonhospitalized patients who were at high risk for Covid-19 progression, a 3-day course of remdesivir had an acceptable safety profile and resulted in an 87% lower risk of hospitalization or death than placebo. (Funded by Gilead Sciences; PINETREE number, NCT04501952; EudraCT number, 2020 -003510 -12.
Appendix The authors' full names and academic degrees are as follows: Robert L. Gottlieb
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