Clinical Trials

Ambulatory study*: 2067

Ambulatory COVID-19 patients

IV delivery

Post-exposure prophylaxis
(PEP) study: 2069

Household contacts (HHCs) of index patient (IPs) with COVID-19

SC delivery
*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.
Clinical efficacy
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. | ||||
Risk reduction | 72,5% (p < 0,0001) |
70,9% (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)
M-PL-00002072
References:
- Summary of Product Characteristic https://www.roche.pl/content/dam/rochexx/roche-pl/roche_poland_rwd/pl_PL/documents/SmPC/Ronapreve_1332.pdf
▼The medicinal product is additionally monitored. This will allow you to quickly identify new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Reports of adverse reactions should be submitted to: Department of Monitoring Undesirable Effects of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: + 48 22 49 21 301; fax: + 48 22 49 21 309; website: https://smz.ezdrowie.gov.pl or Roche Polska Sp. z o.o., ul. Domaniewska 39 B, 02-672 Warsaw, tel. +48 22 345 18 88, fax +48 22 345 18 74 or using the application form available at www.roche.pl/portal/pl/zglaszanie_dzialan_niepozadanych.