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Evaluation of the Effects of Remdesivir and Hydroxychloroquine on Viral Clearance in COVID-19 : A Randomized Trial.
Barratt-Due, Andreas; Olsen, Inge Christoffer; Nezvalova-Henriksen, Katerina; Kåsine, Trine; Lund-Johansen, Fridtjof; Hoel, Hedda; Holten, Aleksander Rygh; Tveita, Anders; Mathiessen, Alexander; Haugli, Mette; Eiken, Ragnhild; Kildal, Anders Benjamin; Berg, Åse; Johannessen, Asgeir; Heggelund, Lars; Dahl, Tuva Børresdatter; Skåra, Karoline Hansen; Mielnik, Pawel; Le, Lan Ai Kieu; Thoresen, Lars; Ernst, Gernot; Hoff, Dag Arne Lihaug; Skudal, Hilde; Kittang, Bård Reiakvam; Olsen, Roy Bjørkholt; Tholin, Birgitte; Ystrøm, Carl Magnus; Skei, Nina Vibeche; Tran, Trung; Dudman, Susanne; Andersen, Jan Terje; Hannula, Raisa; Dalgard, Olav; Finbråten, Ane-Kristine; Tonby, Kristian; Blomberg, Bjorn; Aballi, Saad; Fladeby, Cathrine; Steffensen, Anne; Müller, Fredrik; Dyrhol-Riise, Anne Ma; Trøseid, Marius; Aukrust, Pål.
  • Barratt-Due A; Oslo University Hospital, Oslo, Norway (A.B., I.C.O., T.K., T.T., C.F.).
  • Olsen IC; Oslo University Hospital, Oslo, Norway (A.B., I.C.O., T.K., T.T., C.F.).
  • Nezvalova-Henriksen K; Oslo University Hospital and Hospital Pharmacies, South-Eastern Norway Enterprise, Oslo, Norway (K.N.).
  • Kåsine T; Oslo University Hospital, Oslo, Norway (A.B., I.C.O., T.K., T.T., C.F.).
  • Lund-Johansen F; Oslo University Hospital and ImmunoLingo Convergence Centre, University of Oslo, Oslo, Norway (F.L.).
  • Hoel H; Institute of Clinical Medicine and Research Institute of Internal Medicine, Oslo University Hospital, and Lovisenberg Diaconal Hospital, Oslo, Norway (H.H.).
  • Holten AR; Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway (A.R.H., S.D., J.T.A., K.T., A.S., F.M., A.M.D., M.T.).
  • Tveita A; Bærum Hospital, Vestre Viken Hospital Trust, Drammen, Norway (A.T.).
  • Mathiessen A; Diakonhjemmet Hospital, Oslo, Norway (A.M.).
  • Haugli M; Sørlandet Hospital SSK, Kristiansand, Norway (M.H.).
  • Eiken R; Innlandet Hospital Trust, Lillehammer, Norway (R.E.).
  • Kildal AB; University Hospital of North Norway, Tromsø, Norway (A.B.K.).
  • Berg Å; Stavanger University Hospital, Stavanger, Norway (Å.B.).
  • Johannessen A; Institute of Clinical Medicine, Oslo University Hospital, Oslo, and Vestfold Hospital Trust, Tønsberg, Norway (A.J.).
  • Heggelund L; Drammen Hospital, Vestre Viken Hospital Trust, Drammen, and University of Bergen, Bergen, Norway (L.H.).
  • Dahl TB; Research Institute of Internal Medicine, Oslo University Hospital, Oslo, Norway (T.B.D., K.H.S.).
  • Skåra KH; Research Institute of Internal Medicine, Oslo University Hospital, Oslo, Norway (T.B.D., K.H.S.).
  • Mielnik P; Førde Central Hospital, Førde, Norway (P.M.).
  • Le LAK; Haugesund Hospital, Haugesund, Norway (L.A.K.).
  • Thoresen L; Ringerike Hospital, Vestre Viken Hospital Trust, Ringerike, Norway (L.T.).
  • Ernst G; Kongsberg Hospital, Vestre Viken Hospital Trust, Drammen, Norway (G.E.).
  • Hoff DAL; Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway (D.A.L.).
  • Skudal H; Telemark Hospital Trust, Skien, Norway (H.S.).
  • Kittang BR; Haraldsplass Deaconess Hospital, Bergen, Norway (B.R.K.).
  • Olsen RB; Sorlandet Hospital, Arendal, Norway (R.B.O.).
  • Tholin B; Molde Hospital, Møre and Romsdal Hospital Trust, Molde, Norway (B.T.).
  • Ystrøm CM; Innlandet Hospital Trust, Elverum, Norway (C.M.Y.).
  • Skei NV; Levanger Hospital, Nord-Trøndelag Hospital Trust, Levanger, Norway (N.V.S.).
  • Tran T; Oslo University Hospital, Oslo, Norway (A.B., I.C.O., T.K., T.T., C.F.).
  • Dudman S; Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway (A.R.H., S.D., J.T.A., K.T., A.S., F.M., A.M.D., M.T.).
  • Andersen JT; Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway (A.R.H., S.D., J.T.A., K.T., A.S., F.M., A.M.D., M.T.).
  • Hannula R; Trondheim University Hospital, Trondheim, Norway (R.H.).
  • Dalgard O; Institute of Clinical Medicine, Oslo University Hospital, Oslo, and Akershus University Hospital, Lørenskog, Norway (O.D.).
  • Finbråten AK; Unger-Vetlesen Institute, Lovisenberg Diaconal Hospital, Oslo, Norway (A.F.).
  • Tonby K; Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway (A.R.H., S.D., J.T.A., K.T., A.S., F.M., A.M.D., M.T.).
  • Blomberg B; Haukeland University Hospital and University of Bergen, Bergen, Norway (B.B.).
  • Aballi S; Østfold Hospital Kalnes, Grålum, Norway (S.A.).
  • Fladeby C; Oslo University Hospital, Oslo, Norway (A.B., I.C.O., T.K., T.T., C.F.).
  • Steffensen A; Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway (A.R.H., S.D., J.T.A., K.T., A.S., F.M., A.M.D., M.T.).
  • Müller F; Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway (A.R.H., S.D., J.T.A., K.T., A.S., F.M., A.M.D., M.T.).
  • Dyrhol-Riise AM; Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway (A.R.H., S.D., J.T.A., K.T., A.S., F.M., A.M.D., M.T.).
  • Trøseid M; Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway (A.R.H., S.D., J.T.A., K.T., A.S., F.M., A.M.D., M.T.).
  • Aukrust P; Institute of Clinical Medicine and Research Institute of Internal Medicine, Oslo University Hospital, Oslo, Norway (P.A.).
Ann Intern Med ; 174(9): 1261-1269, 2021 09.
Article in English | MEDLINE | ID: covidwho-1547664
ABSTRACT

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. PRIMARY FUNDING SOURCE National Clinical Therapy Research in the Specialist Health Services, Norway.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Adenosine Monophosphate / Viral Load / Alanine / COVID-19 / Hydroxychloroquine Type of study: Controlled clinical trial / Randomized controlled trials Limits: Female / Humans / Male / Middle aged Country/Region as subject: Europa Language: English Journal: Ann Intern Med Year: 2021 Document Type: Article

Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Adenosine Monophosphate / Viral Load / Alanine / COVID-19 / Hydroxychloroquine Type of study: Controlled clinical trial / Randomized controlled trials Limits: Female / Humans / Male / Middle aged Country/Region as subject: Europa Language: English Journal: Ann Intern Med Year: 2021 Document Type: Article