Ambulatory study*: 2067
Ambulatory COVID-19 patients
(PEP) study: 2069
Household contacts (HHCs) of index patient (IPs) with COVID-19
*Treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
Treatment of COVID-19
COV-2067 was a randomised, double-blinded, placebo-controlled clinical trial evaluating casirivimab and imdevimab for the treatment of subjects with COVID-19 (symptomatic with SARS-CoV-2 detected by quantitative reverse transcription polymerase chain reaction [RT-qPCR]) who did not require supplemental oxygen. In Phase 3 Cohort 1 of this trial, subjects not previously vaccinated against SARS-CoV-2 were randomised within 7 days of symptom onset to a single intravenous infusion of 600 mg of casirivimab and 600 mg of imdevimab (n = 1 347), 1 200 mg of casirivimab and 1 200 mg of imdevimab (n = 2 036) or placebo (n = 2 009). Subjects in Phase 3 Cohort 1 had at least one protocol-listed risk factor for developing severe COVID19 (these included age > 50 years, obesity defined as BMI ≥ 30 kg/m2 , cardiovascular disease including hypertension, chronic lung disease including asthma, type 1 and 2 diabetes mellitus, chronic kidney disease including those on dialysis, chronic liver disease, pregnancy and immunosuppressed). The median age was 50 years (with 13.1% of subjects aged 65 years or older) and 51.4% of the subjects were female. Baseline demographics and disease characteristics were well balanced across the casirivimab and imdevimab and placebo treatment groups. The primary endpoint was the proportion of subjects with ≥ 1 COVID-19-related hospitalisation or all cause death through Day 29.
Tabel 6: Summary of primary endpoint phase 3 results from study COV-2067
|1200 mg IV||placebo||2400 mg IV||placebo|
|n = 1192||n = 1193||n = 1812||n = 1790|
|Patients in the mFAS with ≥1 COVID-19 related hospitalization or death through day 29.|
(p < 0,0001)
(p < 0,0001)
|Number of patients with events||11 (0,9%)||40 (3,4%)||23 (1,3%)||78 (4,4%)|
mFAS: modified full analysis set included those subjects with a positive SARS-CoV-2 RT-qPCR result from nasopharyngeal (NP) swab at randomization, and with at least one risk factor for severe COVID-19.
The median time to symptom resolution, as recorded in a trial-specific daily symptom diary, was reduced from 13 days with placebo to 10 days with both doses of casirivimab and imdevimab (p<0.0001)
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