Phase 4
Completed N=265
Clinical Study to Compare Efficacy and Safety of Casirivimab and Imdevimab Combination, Remdesivir and Favipravir in Hospitalized COVID-19 Patients
COVID-19
Source: ClinicalTrials.gov NCT05502081 ↗
Enrolled (actual)
265
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: 28-days Mortality Rate — 1; 34; 43; 52 Participants — p=<0.001
◆ Published Evidence
Emerging
10citations · ~3 / year
Clinical study to compare the efficacy and safety of casirivimab & imdevimab, remdesivir, and favipravir in hospitalized COVID-19 patients.
Summary
Introduction:
Corona Virus induced disease - 2019 (COVID-19) pandemic stimulates research works to find a solution to this crisis from starting 2020 year up to now. With ending of 2021 year, various advances in pharmacotherapy against COVID-19 have emerged.
Regarding antiviral therapy, Casirivimab and imdevimab antibody combination is a type of new immunotherapy against COVID-19. Standard antiviral therapy against COVID-19 includes Remdesivir and Favipravir.
Aim of Study:
1. To compare the efficacy of antibodies cocktail (casirivimab and imdevimab), Remdesivir and Favipravir in reducing 28-day mortality in hospitalized patients with moderate, severe or critical COVID19
2. To compare safety of antibodies cocktail (casirivimab and imdevimab), Remdesivir and Favipravir by monitoring hypersensitivity and infusion related reactions or other significant adverse effects
Patients and Population:
265 COVID-19 Polymerase Chain Reaction (PCR) confirmed patients with indication for antiviral therapy is included in this study and will be divided into 3 groups (1:2:2):
1. Group A: REGN3048-3051(Antibodies cocktail (casirivimab and imdevimab))
2. group B: Remdesivir
3. group C: Favipravir
Methods:
Study design is single blind non-Randomized Controlled Trial (non-RCT). The drugs of the study are owned by Mansoura University Hospital (MUH), and prescribed by chest diseases lectures of faculty of medicine-Mansoura University. The duration of study is about 6 months after ethical approval.
Linked Publications
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Clinical study to compare the efficacy and safety of casirivimab & imdevimab, remdesivir, and favipravir in hospitalized COVID-19 patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 28-days Mortality Rate |
1; 34; 43; 52; 72; 63 | <0.001 sig |
| PRIMARY Number of Participants With Positive or Negative Polymerase Chain Reaction (PCR) Test Results at End of Hospital Visit |
36; 92; 78; 17; 14; 28 | 0.011 sig |
| PRIMARY Number of Participants With Infusion Related Reactions, Hypersensitivity Reactions and Any Serious Adverse Events |
0; 0; 0; 53; 106; 106 | 0.99 |
| SECONDARY Need for Invasive Mechanical Ventilation |
1; 22; 22; 52; 84; 84 | 0.005 sig |
| SECONDARY Oxygen Support Duration (Days) |
3.72; 9.2; 7.46 | <0.001 sig |
| SECONDARY Time to Clinical Improvement (Defined as 2 Points Reduction in the WHO Disease Ordinal Progression Scale or Discharge, Whatever Happens First |
7.4; 8.33; 7.75 | 0.933 |
| SECONDARY Duration of Hospitalization |
8.94; 11.85; 10.59 | 0.011 sig |
| SECONDARY Sequential Organ Function Assessment (SOFA) Score on Day 3 |
12; 1; 1; 3; 8; 6 | <0.001 sig |
| SECONDARY COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 3 |
0; 1; 0; 25; 17; 17 | <0.001 sig |
| SECONDARY Aspartate Aminotransferase (AST) at Day 3 |
48.53; 48.67; 43.93 | 0.412 |
| SECONDARY Ferritin at Day 3 |
393.04; 427.25; 1110 | 0.106 |
| SECONDARY Lactate Dehydrogenase (LDH) at Day 3 |
351.27; 404.45; 354.7 | 0.01 sig |
| SECONDARY D-dimer at Day 3 |
0.244; 0.23; 0.29 | 0.219 |
| SECONDARY Alanine Aminotransferase (ALT) at Day 3 |
33.62; 36.46; 36.16 | 0.298 |
| SECONDARY Albumin at Day 3 |
3.157; 2.947; 2.854 | 0.015 sig |
| SECONDARY Bilirubin at Day 3 |
0.4793; 0.6457; 0.7053 | 0.68 |
| SECONDARY C-reactive Protein (CRP) at Day 3 |
33.89; 52.61; 64.1 | 0.002 sig |
| SECONDARY Duration of Intensive Care Unit (ICU) Stay |
1.45; 7.6; 6.69 | <0.001 sig |
| SECONDARY C-reactive Protein (CRP) at Day 7 |
14.06; 47.43; 65.73 | <0.001 sig |
| SECONDARY C-reactive Protein (CRP) at Day 14 |
7.5; 37.05; 39.31 | 0.516 |
| SECONDARY C-reactive Protein (CRP) at Day 28 |
39; 96 | 0.264 |
| SECONDARY Sequential Organ Function Assessment (SOFA) Score on Day 7 |
5; 1; 1; 18; 4; 4 | <0.001 sig |
| SECONDARY Sequential Organ Function Assessment Score (SOFA) on Day 14 |
3; 1; 0; 1; 1; 1 | 0.008 sig |
| SECONDARY Sequential Organ Function Assessment Score (SOFA) on Day 28 |
1; 0; 1; 0; 1; 0 | 0.157 |
| SECONDARY COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 7 |
28; 20; 21; 11; 28; 22 | <0.001 sig |
| SECONDARY COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 14 |
4; 2; 7; 0; 8; 4 | 0.015 sig |
| SECONDARY COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 28 |
2; 0; 2; 0; 0; 1 | 0.136 |
| SECONDARY Aspartate Aminotransferase (AST) at Day 7 |
41.77; 35.26; 41.35 | 0.687 |
| SECONDARY Aspartate Aminotransferase (AST) at Day 14 |
26.75; 22.79; 30.19 | 0.278 |
| SECONDARY Aspartate Aminotransferase (AST) at Day 28 |
31; 27 | 0.99 |
| SECONDARY Alanine Aminotransferase (ALT) at Day 7 |
26; 30.54; 33.90 | 0.574 |
| SECONDARY Alanine Aminotransferase (ALT) at Day 14 |
15.75; 22.42; 35.38 | 0.017 sig |
| SECONDARY Alanine Aminotransferase (ALT) at Day 28 |
71.75; 39.5 | 0.99 |
| SECONDARY Bilirubin at Day 7 |
0.3717; 0.6575; 0.8886 | <0.001 sig |
| SECONDARY Bilirubin at Day 14 |
0.3625; 0.494; 0.6888 | 0.088 |
| SECONDARY Bilirubin at Day 28 |
0.41; 1.67 | 0.157 |
| SECONDARY Albumin at Day 7 |
2.98; 2.77; 2.644 | 0.006 sig |
| SECONDARY Albumin at Day 14 |
3.425; 2.82; 2.813 | 0.037 sig |
| SECONDARY Albumin at Day 28 |
2.575; 2.7 | 0.48 |
| SECONDARY Platelets at Day 3 |
271.64; 253.425; 226.35 | 0.047 sig |
| SECONDARY Platelets at Day 7 |
268.829; 243.514; 212.76 | 0.015 sig |
| SECONDARY Platelets at Day 14 |
248; 216.95; 215.63 | 0.814 |
| SECONDARY Platelets at Day 28 |
246.75; 15 | 0.157 |
| SECONDARY Serum Creatinine (S.Cr) at Day 3 |
1.0769; 0.9546; 1.6568 | <0.001 sig |
| SECONDARY Serum Creatinine (S.Cr) at Day 7 |
0.9674; 0.9952; 1.6541 | 0.001 sig |
| SECONDARY Serum Creatinine (S.Cr) at Day 14 |
0.775; 0.6316; 1.45 | 0.007 sig |
| SECONDARY Serum Creatinine (S.Cr) at Day 28 |
0.525; 1.2 | 0.157 |
| SECONDARY D-dimer at Day 7 |
0.109; 0.319; 0.425 | 0.015 sig |
| SECONDARY D-dimer at Day 14 |
0.05; 0.41; 0.313 | 0.423 |
| SECONDARY D-dimer at Day 28 |
0.4; 0.4 | 0.429 |
| SECONDARY Creatine Kinase (Ck) at Day 3 |
142.2; 197.94; 181.45 | 0.089 |
| SECONDARY Creatine Kinase (Ck) at Day 7 |
126.743; 211.9; 175.99 | 0.222 |
| SECONDARY Creatine Kinase (Ck) at Day 14 |
49.5; 122.89; 142.75 | 0.252 |
| SECONDARY Creatine Kinase (Ck) at Day 28 |
119.22; 134.25 | 0.157 |
| SECONDARY Lactate Dehydrogenase (LDH) at Day 7 |
271.4; 371.37; 349.68 | 0.007 sig |
| SECONDARY Lactate Dehydrogenase (LDH) at Day 14 |
379.75; 360.89; 306.88 | 0.457 |
| SECONDARY Lactate Dehydrogenase (LDH) at Day 28 |
314.5; 270 | 0.48 |
| SECONDARY Ferritin at Day 7 |
368.42; 450.37; 1433 | 0.01 sig |
| SECONDARY Ferritin at Day 14 |
398.5; 637.37; 519.88 | 0.293 |
| SECONDARY Ferritin at Day 28 |
1355; 410 | 0.157 |
| SECONDARY Incidence of Acute Kidney Injury (AKI) |
1; 4; 7; 52; 102; 99 | 0.36 |
| SECONDARY Incidence of Acute Liver Damage (ALD) |
1; 6; 3; 52; 100; 103 | 0.404 |
| SECONDARY Day of Death |
0.19; 12.57; 10.13 | <0.001 sig |
| SECONDARY Mortality at Discharge |
1; 33; 41; 52; 73; 65 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- age more than 12 years old.
- weight not less than 40 kg.
- Moderate, sever or critical COVID-19 disease as defined by WHO.
- PCR- confirmed patients to be Positive before inclusion.
Exclusion Criteria
- history of hypersensitivity or infusion related reactions after administration of monoclonal antibodies.
- prior use of standard antiviral therapy (remedsvir or favipravir).
- Current use of controversial antiviral therapy (hydroxychloroquine, ivermectin, nitazoxanide, oseltemavir, acyclovir, ribavirine, lopinvir/rotinvir, sofosfbuvir, decltasevir, semipirvir, azithromycin).
- patients expected to die within 48 hours.
Data sourced from ClinicalTrials.gov (NCT05502081) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.