Evaluation of the Effects of Remdesivir and Hydroxychloroquine on Viral Clearance in COVID-19 A Randomized Trial

被引：83

作者：

Barratt-Due, Andreas ^{[1
]}

Olsen, Inge Christoffer ^{[1
]}

Nezvalova-Henriksen, Katerina ^{[1
,2
]}

Kasine, Trine ^{[1
]}

Lund-Johansen, Fridtjof ^{[1
,3
]}

Hoel, Hedda ^{[4
,5
,6
]}

Holten, Aleksander Rygh ^{[4
]}

Tveita, Anders ^{[7
]}

Mathiessen, Alexander ^{[8
]}

Haugli, Mette ^{[9
]}

Eiken, Ragnhild ^{[10
]}

Kildal, Anders Benjamin ^{[11
]}

Berg, Ase ^{[12
]}

Johannessen, Asgeir ^{[4
,13
]}

Heggelund, Lars ^{[14
,15
]}

Dahl, Tuva Borresdatter ^{[5
]}

Skara, Karoline Hansen ^{[5
]}

Mielnik, Pawel ^{[16
]}

Le, Lan Ai Kieu ^{[17
]}

Thoresen, Lars ^{[18
]}

Ernst, Gernot ^{[19
]}

Hoff, Dag Arne Lihaug ^{[20
]}

Skudal, Hilde ^{[21
]}

Kittang, Bard Reiakvam ^{[22
]}

Olsen, Roy Bjorkholt ^{[23
]}

Tholin, Birgitte ^{[24
]}

Ystrom, Carl Magnus ^{[25
]}

Skei, Nina Vibeche ^{[26
]}

Tran, Trung ^{[1
]}

Dudman, Susanne ^{[4
]}

Andersen, Jan Terje ^{[4
]}

Hannula, Raisa ^{[27
]}

Dalgard, Olav ^{[4
,28
]}

Finbraten, Ane-Kristine ^{[29
]}

Tonby, Kristian ^{[4
]}

Blomberg, Bjorn ^{[15
,30
]}

Aballi, Saad ^{[31
]}

Fladeby, Cathrine ^{[1
]}

Steffensen, Anne ^{[4
]}

Muller, Fredrik ^{[4
]}

Dyrhol-Riise, Anne Ma ^{[4
]}

Troseid, Marius ^{[4
]}

Aukrust, Pal ^{[4
,5
]}

机构：

[1] Oslo Univ Hosp, Oslo, Norway

[2] South Eastern Norway Enterprise, Hosp Pharm, Oslo, Norway

[3] Univ Oslo, ImmunoLingo Convergence Ctr, Oslo, Norway

[4] Oslo Univ Hosp, Inst Clin Med, Oslo, Norway

[5] Oslo Univ Hosp, Res Inst Internal Med, Oslo, Norway

[6] Lovisenberg Diaconal Hosp, Oslo, Norway

[7] Vestre Viken Hosp Trust, Baerum Hosp, Drammen, Norway

[8] Diakonhjemmet Hosp, Oslo, Norway

[9] Sorlandet Hosp SSK, Kristiansand, Norway

[10] Innlandet Hosp Trust, Lillehammer, Norway

[11] Univ Hosp North Norway, Tromso, Norway

[12] Stavanger Univ Hosp, Stavanger, Norway

[13] Vestfold Hosp Trust, Tonsberg, Norway

[14] Vestre Viken Hosp Trust, Drammen Hosp, Drammen, Norway

[15] Univ Bergen, Bergen, Norway

[16] Forde Cent Hosp, Forde, Norway

[17] Haugesund Hosp, Haugesund, Norway

[18] Vestre Viken Hosp Trust, Ringerike Hosp, Ringerike, Norway

[19] Vestre Viken Hosp Trust, Kongsberg Hosp, Drammen, Norway

[20] More & Romsdal Hosp Trust, Alesund Hosp, Alesund, Norway

[21] Telemark Hosp Trust, Skien, Norway

[22] Haraldsplass Deaconess Hosp, Bergen, Norway

[23] Sorlandet Hosp, Arendal, Norway

[24] More & Romsdal Hosp Trust, Molde Hosp, Molde, Norway

[25] Innlandet Hosp Trust, Elverum, Norway

[26] Nord Trondelag Hosp Trust, Levanger Hosp, Levanger, Norway

[27] Trondheim Reg & Univ Hosp, Trondheim, Norway

[28] Akershus Univ Hosp, Lorenskog, Norway

[29] Lovisenberg Diaconal Hosp, Unger Vetlesen Inst, Oslo, Norway

[30] Haukeland Hosp, Bergen, Norway

[31] Ostfold Hosp Kalnes, Gralum, Norway

来源：

ANNALS OF INTERNAL MEDICINE | 2021年 / 174卷 / 09期

关键词：

D O I：

10.7326/M21-0653

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background: New treatment modalities are urgently needed for patients with COVID-19. The World Health Organization (WHO) Solidarity trial showed no effect of remdesivir or hydroxychloroquine (HCQ) on mortality, but the antiviral effects of these drugs are not known. Objective: To evaluate the effects of remdesivir and HCQ on all-cause, in-hospital mortality; the degree of respiratory failure and inflammation; and viral clearance in the oropharynx. Design: NOR-Solidarity is an independent, add-on, randomized controlled trial to the WHO Solidarity trial that included biobanking and 3 months of clinical follow-up (ClinicalTrials. gov: NCT04321616) Setting: 23 hospitals in Norway. Patients: Eligible patients were adults hospitalized with confirmed SARS-CoV-2 infection. Intervention: Between 28 March and 4 October 2020, a total of 185 patients were randomly assigned and 181 were included in the full analysis set. Patients received remdesivir (n= 42), HCQ (n = 52), or standard of care (SoC) (n = 87). Measurements: In addition to the primary end point of WHO Solidarity, study-specific outcomes were viral clearance in oropharyngeal specimens, the degree of respiratory failure, and inflammatory variables. Results: No significant differences were seen between treatment groups in mortality during hospitalization. There was a marked decrease in SARS-CoV-2 load in the oropharynx during the first week overall, with similar decreases and 10-day viral loads among the remdesivir, HCQ, and SoC groups. Remdesivir and HCQ did not affect the degree of respiratory failure or inflammatory variables in plasma or serum. The lack of antiviral effect was not associated with symptom duration, level of viral load, degree of inflammation, or presence of antibodies against SARS-CoV-2 at hospital admittance. Limitation: The trial had no placebo group. Conclusion: Neither remdesivir nor HCQ affected viral clearance in hospitalized patients with COVID-19.

引用

页码：1261 / +

页数：23

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