0
0.5
1
1.5
2+
Mortality
22%
Improvement
Relative Risk
c19 hcq.org
Goldman et al. HCQ for COVID-19 LATE TREATMENT
Is late treatment with HCQ beneficial for COVID-19?
Retrospective 397 patients in multiple countries
Lower mortality with HCQ (not stat. sig., p=0.46)
Goldman et al., NEJM, doi:10.1056/NEJMoa2015301
Favors HCQ
Favors control
Remdesivir for 5 or 10 Days in Patients with Severe Covid-19
Study focused on remdesivir but with results for HCQ in the supplementary appendix, showing 9% death with HCQ versus 12% control, unadjusted relative risk uRR 0.78,
p = 0.46.
Although the 22% lower mortality is not statistically significant, it is consistent with the significant 22% lower mortality
[18‑27%] from meta analysis of the
232 mortality results to date .
This study is excluded in the after exclusion results of meta
analysis:
unadjusted results with no group details.
risk of death, 22.3% lower , RR 0.78, p = 0.46 , treatment 10 of 109 (9.2%), control 34 of 288 (11.8%), NNT 38.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Goldman et al., 27 May 2020, retrospective, multiple countries, peer-reviewed, 26 authors.
Abstract: The
n e w e ng l a n d j o u r na l
of
m e dic i n e
Original Article
Remdesivir for 5 or 10 Days in Patients
with Severe Covid-19
Jason D. Goldman, M.D., M.P.H., David C.B. Lye, M.B., B.S., David S. Hui, M.D.,
Kristen M. Marks, M.D., Raffaele Bruno, M.D., Rocio Montejano, M.D.,
Christoph D. Spinner, M.D., Massimo Galli, M.D., Mi‑Young Ahn, M.D.,
Ronald G. Nahass, M.D., Yao‑Shen Chen, M.D., Devi SenGupta, M.D.,
Robert H. Hyland, D.Phil., Anu O. Osinusi, M.D., Huyen Cao, M.D.,
Christiana Blair, M.S., Xuelian Wei, Ph.D., Anuj Gaggar, M.D., Ph.D.,
Diana M. Brainard, M.D., William J. Towner, M.D., Jose Muñoz, M.D.,
Kathleen M. Mullane, D.O., Pharm.D., Francisco M. Marty, M.D.,
Karen T. Tashima, M.D., George Diaz, M.D., and Aruna Subramanian, M.D.,
for the GS-US-540-5773 Investigators*
A BS T R AC T
BACKGROUND
Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro
and efficacy in animal models of coronavirus disease 2019 (Covid-19).
METHODS
We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less
while they were breathing ambient air, and radiologic evidence of pneumonia.
Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir
for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1
and 100 mg once daily on subsequent days. The primary end point was clinical
status on day 14, assessed on a 7-point ordinal scale.
The authors’ affiliations are listed in the
Appendix. Address reprint requests to
Dr. Brainard at Gilead Sciences, 333 Lakeside Dr., Foster City, CA 94404, or at
diana.brainard@gilead.com.
*A list of investigators in the GS-US-5405773 trial is provided in the Supplementary Appendix, available at NEJM.org.
This article was published on May 27, 2020,
at NEJM.org.
N Engl J Med 2020;383:1827-37.
DOI: 10.1056/NEJMoa2015301
Copyright © 2020 Massachusetts Medical Society.
RESULTS
In total, 397 patients underwent randomization and began treatment (200 patients
for 5 days and 197 for 10 days). The median duration of treatment was 5 days
(interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range,
5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day
group had significantly worse clinical status than those assigned to the 5-day
group (P = 0.02). By day 14, a clinical improvement of 2 points or more on the
ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the
10-day group. After adjustment for baseline clinical status, patients in the 10-day
group had a distribution in clinical status at day 14 that was similar to that among
patients in the 5-day group (P = 0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%).
CONCLUSIONS
In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not
show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined.
(Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899.)
n engl j med 383;19
nejm.org
November 5, 2020
The New England Journal of Medicine
Copyright © 2020..
Late treatment is less effective
goldman
Please send us corrections, updates, or comments. Vaccines and
treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, or intervention
is 100% available and effective for all current and future variants. We do not
provide medical advice. Before taking any medication, consult a qualified
physician who can provide personalized advice and details of risks and
benefits based on your medical history and situation.
FLCCC and
WCH
provide treatment protocols.
Submit