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▎Editor of WuXi AppTec's content team On June 16, 2021, Regeneron announced that its in-research and antibody therapy REGEN-COV (casirivimab and imdevimab) has obtained positive preliminary results in the Phase 3 clinical trial RECOVERY
.
The results of the test showed that among COVID-19 hospitalized patients who did not have a natural antibody response to the new coronavirus, the addition of REGEN-COV on the basis of routine care can reduce the risk of death by 20% compared with the control group
.
The press release pointed out that RECOVERY is the first large-scale clinical trial to prove that neutralizing antibodies can reduce the mortality of COVID-19 hospitalized patients
.
Regeneron will immediately discuss the latest research results with regulatory agencies, and request the US FDA to expand the emergency use authorization (EUA) to include appropriate hospitalized patients
.
REGEN-COV is a cocktail therapy consisting of two monoclonal antibodies, which can be administered by intravenous infusion or subcutaneous injection
.
These two antibodies can non-competitively bind to the two independent and non-overlapping sites of the viral spike protein (S protein) receptor binding domain (RBD), and have a synergistic effect, thereby reducing the mutant virus’s escape from treatment.
Ability
.
REGEN-COV has been authorized by the EUA for the treatment of adults and adolescents with mild to moderate COVID-19 who have tested positive for the virus and have a higher risk of developing severe COVID-19 (including hospitalization or death)
.
A total of 9785 COVID-19 hospitalized patients were enrolled in this phase 3 clinical trial, with an average age of 62 years.
One third of the hospitalized patients were serologically negative (n=3153), and half were serologically positive (n=5272) , One-sixth of the serological status is unknown (n=1360)
.
Patients were randomized to receive conventional treatment plus REGEN-COV (8000 mg intravenous infusion), or conventional treatment alone as a control.
99% of the subjects completed the follow-up
.
Image source: The results of the 123RF trial showed that, similar to previous studies, the mortality rate of seronegative patients on day 28 was twice that of serologically positive patients (30% vs.
15%) when only receiving conventional treatment
.
Compared with the control group, at 28 days, the all-cause mortality of seronegative patients in the test group was reduced by 20% (24% vs.
30%; [RR]: 0.
80; 95% CI: 0.
70-0.
91; p=0.
001 )
.
But when the target was expanded from seronegative patients to the entire patient group, the cocktail therapy no longer had a significant effect on the 28-day mortality rate.
The mortality rate was 20% in the experimental group and 21% in the control group (RR: 0.
96; 95% CI: 0.
86-1.
03; p=0.
17)
.
In addition, among seronegative patients, the median hospital stay in the experimental group was 4 days shorter (13 days vs.
17 days), the proportion of patients discharged on the 28th day was also higher (64% vs.
58%), and patients in the experimental group progressed The composite endpoint risk of invasive mechanical ventilation or death was lower than that of the control group (30% vs.
37%), and these benefits were not observed in the entire patient group
.
"The RECOVERY trial showed that for COVID-19 patients who did not develop a natural antibody response, REGEN-COV therapy significantly reduced their risk of death or use of ventilators, and shortened their hospital stay
.
"Regeneron Global Clinical Development Executive Vice President Dr.
David Weinreich said, "These results bring hope to patients with poor autoimmune responses to vaccines or viral infections
.
"References: [1] REGEN-COV™ (CASIRIVIMAB AND IMDEVIMAB) PHASE 3 RECOVERY TRIAL MEETS PRIMARY OUTCOME, IMPROVING SURVIVAL IN HOSPITALIZED COVID-19 PATIENTS LACKING AN IMMUNE RESPONSE TO SARS-COV-2.
Retrieved June 16, 2021, from https://investor.
regeneron.
com/news-releases/news-release-details/regen-covtm-casirivimab-and-imdevimab-phase-3-recovery-trial Note: This article aims to introduce medical and health research progress, not treatment Program recommendation
.
If you need treatment program guidance, please go to a regular hospital for treatment
.
.
The results of the test showed that among COVID-19 hospitalized patients who did not have a natural antibody response to the new coronavirus, the addition of REGEN-COV on the basis of routine care can reduce the risk of death by 20% compared with the control group
.
The press release pointed out that RECOVERY is the first large-scale clinical trial to prove that neutralizing antibodies can reduce the mortality of COVID-19 hospitalized patients
.
Regeneron will immediately discuss the latest research results with regulatory agencies, and request the US FDA to expand the emergency use authorization (EUA) to include appropriate hospitalized patients
.
REGEN-COV is a cocktail therapy consisting of two monoclonal antibodies, which can be administered by intravenous infusion or subcutaneous injection
.
These two antibodies can non-competitively bind to the two independent and non-overlapping sites of the viral spike protein (S protein) receptor binding domain (RBD), and have a synergistic effect, thereby reducing the mutant virus’s escape from treatment.
Ability
.
REGEN-COV has been authorized by the EUA for the treatment of adults and adolescents with mild to moderate COVID-19 who have tested positive for the virus and have a higher risk of developing severe COVID-19 (including hospitalization or death)
.
A total of 9785 COVID-19 hospitalized patients were enrolled in this phase 3 clinical trial, with an average age of 62 years.
One third of the hospitalized patients were serologically negative (n=3153), and half were serologically positive (n=5272) , One-sixth of the serological status is unknown (n=1360)
.
Patients were randomized to receive conventional treatment plus REGEN-COV (8000 mg intravenous infusion), or conventional treatment alone as a control.
99% of the subjects completed the follow-up
.
Image source: The results of the 123RF trial showed that, similar to previous studies, the mortality rate of seronegative patients on day 28 was twice that of serologically positive patients (30% vs.
15%) when only receiving conventional treatment
.
Compared with the control group, at 28 days, the all-cause mortality of seronegative patients in the test group was reduced by 20% (24% vs.
30%; [RR]: 0.
80; 95% CI: 0.
70-0.
91; p=0.
001 )
.
But when the target was expanded from seronegative patients to the entire patient group, the cocktail therapy no longer had a significant effect on the 28-day mortality rate.
The mortality rate was 20% in the experimental group and 21% in the control group (RR: 0.
96; 95% CI: 0.
86-1.
03; p=0.
17)
.
In addition, among seronegative patients, the median hospital stay in the experimental group was 4 days shorter (13 days vs.
17 days), the proportion of patients discharged on the 28th day was also higher (64% vs.
58%), and patients in the experimental group progressed The composite endpoint risk of invasive mechanical ventilation or death was lower than that of the control group (30% vs.
37%), and these benefits were not observed in the entire patient group
.
"The RECOVERY trial showed that for COVID-19 patients who did not develop a natural antibody response, REGEN-COV therapy significantly reduced their risk of death or use of ventilators, and shortened their hospital stay
.
"Regeneron Global Clinical Development Executive Vice President Dr.
David Weinreich said, "These results bring hope to patients with poor autoimmune responses to vaccines or viral infections
.
"References: [1] REGEN-COV™ (CASIRIVIMAB AND IMDEVIMAB) PHASE 3 RECOVERY TRIAL MEETS PRIMARY OUTCOME, IMPROVING SURVIVAL IN HOSPITALIZED COVID-19 PATIENTS LACKING AN IMMUNE RESPONSE TO SARS-COV-2.
Retrieved June 16, 2021, from https://investor.
regeneron.
com/news-releases/news-release-details/regen-covtm-casirivimab-and-imdevimab-phase-3-recovery-trial Note: This article aims to introduce medical and health research progress, not treatment Program recommendation
.
If you need treatment program guidance, please go to a regular hospital for treatment
.
