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Casirivimab and imdevimab in patients admitted to hospital with COVID-19: RECOVERY Trial
Casirivimab and imdevimab are non-competing monoclonal antibodies that bind to two different sites on the receptor-binding domain of the SARS-CoV-2 spike glycoprotein, blocking viral entry into host cells. RECOVERY is a randomized, controlled, open-label platform trial comparing several possible treatments with usual care in patients admitted to hospital with COVID-19. The current study is aimed to evaluate the efficacy and safety of casirivimab and imdevimab administered in combination in patients admitted to hospital with COVID-19.
- Eligibility criteria: Patients admitted to the hospital were eligible for the study if they had clinically suspected or laboratory-confirmed SARS-CoV-2 infection and no medical history that might put the patient at significant risk.
- Total 9785 patients enrolled among which 4839 were randomly assigned to casirivimab and imdevimab plus usual care and 4946 to usual care alone.
- Primary outcome: 28-day all-cause mortality assessed by intention to treat, first only in patients without detectable antibodies to SARS-CoV-2 infection at randomization (ie, those who were seronegative) and then in the overall population.
- Secondary outcomes: Time to discharge from hospital, and, in patients not on invasive mechanical ventilation at randomisation, the composite outcome of invasive mechanical ventilation (including ECMO) or death.
- Safety was assessed in all participants who received casirivimab and imdevimab.
- At randomisation, 5272 (54%) were seropositive at baseline, 3153 (32%) were seronegative, and serostatus was unknown for 1360 (14%).
- Other COVID-19 treatments was similar among patients allocated casirivimab and imdevimab and among those allocated usual care, with about 25% receiving remdesivir and about 15% receiving tocilizumab or sarilumab.
- In the primary efficacy population of seronegative patients, 396 (24%) of 1633 patients allocated to casirivimab and imdevimab vs. 452 (30%) of 1520 patients allocated to usual care died within 28 days (rate ratio [RR] 0·79, 95% CI 0·69–0·91; p=0·0009). Significant redction by 20%
- If treated with Usual care only, seronegative patients had twice the risk of death of seropositive patients (30% vs 15% mortality)
- Casirivimab and imdevimab significantly reduced mortality in seronegative patients by 20% (absolute benefit: from 30% to 24% mortality).
- The proportional effect of casirivimab and imdevimab on mortality differed significantly between seropositive and seronegative patients (p =0·002).
- In all randomly assigned patients, there was no significant difference in the primary outcome. 943 (19%)/4839 patients of casirivimab and imdevimab vs. 1029 (21%)/4946 patients of usual care died within 28 days (RR 0·94, 95% CI 0·86–1·02; p=0·14).
- In seronegative patients, discharge alive within 28 days was more common in casirivimab and imdevimab than usual care group patients.
- The proportional effects of casirivimab and imdevimab on the secondary outcomes of discharge alive from hospital and invasive mechanical ventilation or death differed significantly between seropositive and seronegative patients (p <0·001).
- In seronegative patients not on invasive mechanical ventilation at baseline, casirivimab and imdevimab was associated with a lower risk of progressing to the composite secondary outcome of invasive mechanical ventilation or death.
- In the overall study population;
Frequency of fever (in 79 [4%] of 1792 vs 52 [3%] of 1715)
Sudden hypotension (66 [4%] vs 39 [2%]),
- Thrombotic events (31 [2%] vs 24 [1%]) was numerically higher in the casirivimab and imdevimab group vs usual care group,
- While frequency of sudden worsening in respiratory status (369 [21%] vs 372 [22%]) and clinical haemolysis (26 [1%] vs 31 [2%]) was numerically lower casirivimab and imdevimab group vs usual care group.
- Serious adverse reactions reported in seven (<1%) participants were believed to be related to treatment with casirivimab and imdevimab.
This randomised trial result support the use of combination of casirivimab and imdevimab in seronegative patients admitted to hospital with COVID-19 caused by SARS-CoV-2 variants that are sensitive to these antibodies.
For more details about the prescribing information, click here
Reference: RECOVERY Collaborative Group. Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2022 Feb 12;399(10325):665-676. doi: 10.1016/S0140-6736(22)00163-5.
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Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Before Joining Medical Dialogues, he has served at important positions in the medical industry in India including as the Hony. Secretary of the Delhi Medical Association as well as the chairman of Anti-Quackery Committee in Delhi and worked with other Medical Councils in India. Email: firstname.lastname@example.org. Contact no. 011-43720751