• Andreas Barratt-Due, Inge Christoffer Olsen, Katerina Nezvalova-Henriksen, Trine Kåsine, Fridtjof Lund-Johansen, Hedda Hoel, Aleksander Rygh Holten, Anders Tveita, Alexander Mathiessen, Mette Haugli, Ragnhild Eiken, Anders Benjamin Kildal, Åse Berg, Asgeir Johannessen, Lars Heggelund, Tuva Børresdatter Dahl, Karoline Hansen Skåra, Pawel Mielnik, LeLan Ai KieuLAKHaugesund Hospital, Haugesund, Norway (L.A.K.)., Lars Thoresen, Gernot Ernst, HoffDag Arne LihaugDAL0000-0002-7861-2125Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway (D.A.L.)., Hilde Skudal, Bård Reiakvam Kittang, Roy Bjørkholt Olsen, Birgitte Tholin, Carl Magnus Ystrøm, Nina Vibeche Skei, Trung Tran, Susanne Dudman, Jan Terje Andersen, Raisa Hannula, Olav Dalgard, Ane-Kristine Finbråten, Kristian Tonby, Bjorn Blomberg, Saad Aballi, Cathrine Fladeby, Anne Steffensen, Fredrik Müller, Anne Ma Dyrhol-Riise, Marius Trøseid, Pål Aukrust, and NOR-Solidarity trial.
• Oslo University Hospital, Oslo, Norway (A.B., I.C.O., T.K., T.T., C.F.).
• Ann. Intern. Med. 2021 Sep 1; 174 (9): 1261-1269.

BackgroundNew 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.ObjectiveTo 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.DesignNOR-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).Setting23 hospitals in Norway.PatientsEligible patients were adults hospitalized with confirmed SARS-CoV-2 infection.InterventionBetween 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).MeasurementsIn 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.ResultsNo 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.LimitationThe trial had no placebo group.ConclusionNeither remdesivir nor HCQ affected viral clearance in hospitalized patients with COVID-19.Primary Funding SourceNational Clinical Therapy Research in the Specialist Health Services, Norway.

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