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. 2023 Jan 25;2023(1):CD014962. doi: 10.1002/14651858.CD014962.pub2

WHO Solidarity Norway 2021.

Study characteristics
Methods

  • Trial design: open‐label, adaptive, multicentre, RCT

  • Type of publication: journal publication

  • Setting: inpatient

  • Recruitment dates: from 7 April to 5 October 2020

  • Country: Norway

  • Language: English

  • Number of centres: 23

  • Trial registration number: NCT04321616 (ClinicalTrials.gov)

  • Date of trial registration: 25 March 2020
Participants Baseline characteristics

  • Age (years, mean (SD), intervention group vs control group): 59.7 (16.5) vs 58.1 (15.7)

  • Gender (male, n (%)): intervention group 29 (69); control group 43 (75.4)

  • Ethnicity (geographic region, n (%) intervention group vs n (%) control group): NR

  • Number of participants (recruited/allocated/evaluated): 101/101/83

  • Severity of condition according to the level of respiratory support (intervention group vs control group, (n (%))):

    • hospitalised not requiring supplemental oxygen: NR

    • hospitalised requiring supplemental oxygen: NR

    • hospitalised requiring extracorporeal membrane oxygenation or invasive mechanical ventilation: NR

  • Severity of condition according to the level of medical care (intervention group vs control group, (n (%)):

    • admitted to ward: 39 (92.9) vs 56 (98.2)

    • admitted to ICU: 3 (7.1) vs 1 (1.8)

  • Comorbidities (intervention group vs control group (n (%)):

    • Diabetes: 9 (22) vs 9 (15.8)

    • Chronic cardiac disease: 6 (14.6) vs 12 (21.1)

    • Chronic pulmonary disease: 4 (9.8) vs 3 (5.3)

    • Hypertension: 15 (36.6) vs 14 (24.6)

    • Obesity: 11 (28.9) vs 9 (18.4)


Inclusion criteria:

  • Adult patients, 18 years and above

  • Confirmed SARS‐2‐CoV‐2 infection by PCR

  • Admitted to the hospital ward or the ICU

  • Patient (or legally authorised representative) provides written informed consent prior to initiation of the study


Exclusion criteria:

  1. Severe co‐morbidity with life expectancy < 3 months according to investigators' assessment

  2. (Aspartate transaminase/alanine aminotransferase) ASAT/ALAT > 5 times the upper limit of normal

  3. Acute co‐morbidity within 7 days before inclusion such as myocardial infarction

  4. Known intolerance to the available study drugs

  5. Pregnancy, possible pregnancy, or breastfeeding

  6. Any reason why, in the opinion of the investigators, the patient should not participate

  7. Patient participates in a potentially confounding drug or device trial during the course of the study

  8. Prolonged QT interval (> 450 ms)


Previous treatments: NR
Interventions

  • Treatment details of intervention group: 200 mg of intravenous remdesivir on day 1, then 100 mg daily up to 9 days in addition to standard care

  • Treatment details of control group: standard care

  • Concomitant therapy (intervention group vs control group, n (%)): systemic steroids 1 (2.4) vs 2 (3.6), other immunomodulatory drugs 1 (2.4) vs 1 (1.8), ACE inhibitors 2 (4.9) vs 4 (7.1), angiotensin II receptor blockers 11 (26.8) vs 7 (12.5). Systemic steroids as standard care for severe and critical COVID‐19 from 4 September 2020

  • Duration of follow‐up:

    • 3 months

  • Treatment cross‐overs: no

  • Compliance with assigned treatment: partly (9 participants in the intervention group excluded after randomisation)
Outcomes Primary study outcome: all‐cause, in‐ hospital mortality
Review outcomes (new outcomes, not reported for those patients in the WHO Solidarity Trial Consortium and used for the analyses in this review, are marked)
Primary outcomes

  • All‐cause mortality at day 28, day 60, and at hospital discharge: reported (new)

  • Clinical status at day 28, day 60, and up to longest follow‐up, including:

    • improvement of clinical status; i.e. participants discharged alive. Participants should be discharged without clinical deterioration or death: NR

    • worsening of clinical status; i.e. participants with clinical deterioration, defined as new need for invasive mechanical ventilation or death: NR

  • Adverse events (any grade) during the study period, defined as number of participants with any event: reported (new)

  • Serious adverse events during the study period, defined as number of participants with any event: reported (new)


Secondary outcomes

  • All‐cause mortality, time‐to‐event: NR

  • Quality of life, including fatigue and neurological status, assessed with standardised scales (e.g. WHO Quality of Life 100‐question patient‐reported questionnaire (WHOQOL‐100)) at up to 7 days, up to 28 days, and longest follow‐up available: NR

  • Adverse events grades 3 and 4: NR

  • Ventilator‐free days (defined as days alive and free from mechanical ventilation): NR
Identification  
Notes

  • Date of publication: 13 July 2021

  • Sponsor/funding: National Clinical Therapy Research in the Specialist Health Services, Norway