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Abstract: TH-PO972

Angiotensin Receptor Blockers for Treatment of COVID-19: A Phase 3, Adaptive Multi-Centre, Randomised Controlled Trial

Session Information

Category: Coronavirus (COVID-19)

  • 000 Coronavirus (COVID-19)

Authors

  • Jardine, Meg, The University of Sydney, Camperdown, New South Wales, Australia
  • Kotwal, Sradha S., University of New South Wales, Newtown, New South Wales, Australia
  • Bassi, Abhinav, University of New South Wales, New Delhi, India
  • Hockham, Carinna, Imperial College London, London, United Kingdom
  • Jones, Mark A, The University of Sydney, Camperdown, New South Wales, Australia
  • Wilcox, Arlen, The University of Sydney, Camperdown, New South Wales, Australia
  • Pollock, Carol A., Royal North Shore Hospital, St Leonards, New South Wales, Australia
  • Burrell, Louise, The University of Melbourne, Heidelberg, Victoria, Australia
  • Mcgree, James M, Queensland University of Technology, Brisbane, Queensland, Australia
  • Rathore, Vinay, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India
  • Jenkins, Christine, Concord Repatriation General Hospital, Concord, New South Wales, Australia
  • Gupta, Lalit, Maulana Azad Medical College, New Delhi, New Delhi, India
  • Ritchie, Angus G., Concord Repatriation General Hospital, Concord, New South Wales, Australia
  • Bangi, Ashpak, Jivanrekha Multispeciality Hospital, Pune, Maharashtra, India
  • D'Cruz, Sanjay, Government Medical College and Hospital, Chandigarh, Punjab, India
  • McLachlan, Andrew John, The University of Sydney, Camperdown, New South Wales, Australia
  • Finfer, Simon, University of New South Wales, Newtown, New South Wales, Australia
  • Cummins, Michelle M, The University of Sydney, Camperdown, New South Wales, Australia
  • Snelling, Thomas L, The Sydney Children's Hospitals Network, Westmead, New South Wales, Australia
  • Jha, Vivekanand, University of New South Wales, New Delhi, India

Group or Team Name

  • CLARITY Investigators*
Background

Importance: People with chronic kidney disease may experience worse COVID-19 outcomes than the general population. SARS-CoV-2 virus enters cells via angiotensin-converting enzyme 2 (ACE2) receptors. ACE2 disruption promotes angiotensin type 1 receptor-mediated inflammation, which is potentially countered by angiotensin receptor blockers (ARBs).
Objective: The Controlled evaLuation of Angiotensin Receptor blockers for COVID-19 respIraTorY disease (CLARITY) trial aimed to determine the effect of ARB treatment in SARS-CoV-2 infection.

Methods

Design: CLARITY was a pragmatic, adaptive, multi-centre, phase III, randomised, double-masked, controlled trial. Between May 2020 and November 2021, 787 participants were randomised to ARB (predominantly telmisartan) or control. The trial stopped due to meeting the pre-specified futility rule.
Setting: Seventeen hospital sites in India and Australia.
Participants: Eligible participants were people at least 18 years old, ARB-naïve, and with a laboratory-confirmed diagnosis of SARS-CoV-2 infection who had been hospitalised for management of COVID-19.
Intervention: Oral ARB (telmisartan in India) or placebo (1:1) for 28 days.
Main outcome measures: The primary endpoint was disease severity using a modified World Health Organization Clinical Progression Scale (WHO scale) at Day 14. Secondary outcomes included WHO scale scores at Day 28. Analyses were evaluated on an ordinal scale performed according to intention-to-treat principle.
Trial registration: ClinicalTrials.gov, NCT04394117.

Results

The median WHO scale score at Day 14 was 1 (IQR 1, 2) in participants assigned ARBs and 1 (IQR 1, 3) in participants assigned placebo (adjusted odds ratio [OR] 1.51 [95% credible interval (CrI), 1.02–2.23], Pr(OR〉1) = 0.98). WHO scale scores at Day 28 showed little evidence of difference between groups (adjusted OR 1.02 [95% CrI, 0.55–1.87], Pr(OR〉1) = 0.53).

Conclusion

In patients hospitalised for COVID-19, mostly with mild disease, not requiring oxygen, we found no evidence of benefit for ARBs using predominantly 40 mg/day of telmisartan, based on disease severity score.

Funding

  • Private Foundation Support