NCT05502081

Clinical Study to Compare Efficacy and Safety of Casirivimab and Imdevimab Combination, Remdesivir and Favipravir in Hospitalized COVID-19 Patients

Completed Phase 4 Results posted Last updated 25 July 2023

What this trial tests

Phase 4 trial testing Casirivimab and Imdevimab Drug Combination in COVID-19 in 265 participants. Completed in 28 December 2022.

Timeline

2 September 2022

Primary endpoint
28 December 2022

28 December 2022

Quick facts

Lead sponsor	Mansoura University Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	265
Start date	2 September 2022
Primary completion	28 December 2022
Estimated completion	28 December 2022
Sites	1 location across Egypt

Drugs / interventions tested

• Casirivimab and Imdevimab Drug Combination — full drug profile →
• Remdesivir (remdesivir) — full drug profile →
• Favipiravir (FAVIPIRAVIR) — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Mansoura University Hospital

Who can join

12 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

28-days Mortality Rate Primary · 28 days

Dead or alive

Group	Value	95% CI
Casirivimab and Imdevimab	1
Remdesivir	34
Favipravir	43
Casirivimab and Imdevimab	52
Remdesivir	72
Favipravir	63

Number of Participants With Positive or Negative Polymerase Chain Reaction (PCR) Test Results at End of Hospital Visit Primary · up to 60 days

positive or negative

Group	Value	95% CI
Casirivimab and Imdevimab	36
Remdesivir	92
Favipravir	78
Casirivimab and Imdevimab	17
Remdesivir	14
Favipravir	28

Number of Participants With Infusion Related Reactions, Hypersensitivity Reactions and Any Serious Adverse Events Primary · up to 60 days

yes or no

Group	Value	95% CI
Casirivimab and Imdevimab	0
Remdesivir	0
Favipravir	0
Casirivimab and Imdevimab	53
Remdesivir	106
Favipravir	106

Need for Invasive Mechanical Ventilation Secondary · up to 60 days

yes or no

Group	Value	95% CI
Casirivimab and Imdevimab	1
Remdesivir	22
Favipravir	22
Casirivimab and Imdevimab	52
Remdesivir	84
Favipravir	84

Oxygen Support Duration (Days) Secondary · up to 60 days

in days

Group	Value	95% CI
Casirivimab and Imdevimab	3.72	± 3.527
Remdesivir	9.2	± 7.107
Favipravir	7.46	± 5.077

Time to Clinical Improvement (Defined as 2 Points Reduction in the WHO Disease Ordinal Progression Scale or Discharge, Whatever Happens First Secondary · up to 60 days

in days WHO disease ordinal progression scale 0= Uninfected Ambulatory mild disease 1. Asymptomatic; viral RNA detected 2. Symptomatic; independent. 3. Symptomatic; assistance needed Hospitalized: moderate disease 4. Hospitalized; no oxygen therapy 5. Hospitalized; oxygen by mask or nasal prongs Hospitalized: sever disease 6. Hospitalized; oxygen by NIV or high flow 7. Intubation and mechanical ventilation, pO2 /FIO2 ≥ 150 or Spo2 /FiO2 ≥200 8. Mechanical ventilation pO2/FiO2 \<150 (SpO2 /FiO2 \< 200) or vasopressors 9. Mechanical ventilation pO2 / FiO2 \< 150 and vasopressors, dialysis or E

Group	Value	95% CI
Casirivimab and Imdevimab	7.4	± 3.101
Remdesivir	8.33	± 6.38
Favipravir	7.75	± 4.265

Duration of Hospitalization Secondary · up to 60 days

in days

Group	Value	95% CI
Casirivimab and Imdevimab	8.94	± 3.165
Remdesivir	11.85	± 6.264
Favipravir	10.59	± 5.26

Sequential Organ Function Assessment (SOFA) Score on Day 3 Secondary · Day 3

minimum 0 to maximum 24, higher scores mean worse outcomes Platelets, ×10³/µL ≥150 0 100-149+1 50-99+2 20-49+3 \<20+4 Glasgow Coma Scale If on sedatives, estimate assumed GCS off sedatives 15 0 13-14+1 10-12+2 6-9+3 \<6+4 Bilirubin, mg/dL (μmol/L) \<1.2 (\<20) 0 1.2-1.9 (20-32)+1 2.0-5.9 (33-101)+2 6.0-11.9 (102-204)+3 ≥12.0 (\>204)+4 Mean arterial pressure OR administration of vasoactive agents required Listed doses are in units of mcg/kg/min No hypotension 0 MAP \<70 mmHg+1 DOPamine ≤5 or DOBUTamine (any dose)+2 DOPamine \>5, EPINEPHrine ≤0.1, or norEPINEPHrine ≤0.1+3 DOPamine \>15, EPIN

Group	Value	95% CI
Casirivimab and Imdevimab	12
Remdesivir	1
Favipravir	1
Casirivimab and Imdevimab	3
Remdesivir	8
Favipravir	6
Casirivimab and Imdevimab	12
Remdesivir	12
Favipravir	8
Casirivimab and Imdevimab	18
Remdesivir	24
Favipravir	16

COVID-19 World Health Organization (WHO) Disease Progression Scale at Day 3 Secondary · Day 3

minimum 0 to maximum 10, higher scores mean worse outcomes

Group	Value	95% CI
Casirivimab and Imdevimab	0
Remdesivir	1
Favipravir	0
Casirivimab and Imdevimab	25
Remdesivir	17
Favipravir	17
Casirivimab and Imdevimab	20
Remdesivir	57
Favipravir	58
Casirivimab and Imdevimab	7
Remdesivir	28
Favipravir	22

Aspartate Aminotransferase (AST) at Day 3 Secondary · day 3

continuous level

Group	Value	95% CI
Casirivimab and Imdevimab	48.53	± 60.487
Remdesivir	48.67	± 41.128
Favipravir	43.93	± 36.497

Ferritin at Day 3 Secondary · day 3

continuous level

Group	Value	95% CI
Casirivimab and Imdevimab	393.04	± 170.2
Remdesivir	427.25	± 194.8
Favipravir	1110	± 6784.6

Lactate Dehydrogenase (LDH) at Day 3 Secondary · day 3

continuous level

Group	Value	95% CI
Casirivimab and Imdevimab	351.27	± 258.57
Remdesivir	404.45	± 214.92
Favipravir	354.7	± 204.2

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical study to compare the efficacy and safety of casirivimab & imdevimab, remdesivir, and favipravir in hospitalized COVID-19 patients.
   Hegazy SK, Tharwat S, Hassan AH. · · 2023 · cited 9× · PMID 37220480 · DOI 10.1016/j.jcvp.2023.100151
2. COVID-19 therapeutics: Clinical application of repurposed drugs and futuristic strategies for target-based drug discovery.
   Kumar S, Basu M, Ghosh P, Pal U, et al · · 2023 · cited 7× · PMID 37334160 · DOI 10.1016/j.gendis.2022.12.019
3. Small but Mighty: Nanobodies in the Fight Against Infectious Diseases.
   Jiang W, Huang C, Muyldermans S, Jia L. · · 2025 · cited 4× · PMID 40427503 · DOI 10.3390/biom15050610
4. Study to compare the effect of casirivimab and imdevimab, remdesivir, and favipiravir on progression and multi-organ function of hospitalized COVID-19 patients.
   Hegazy SK, Tharwat S, Hassan AH. · · 2023 · cited 4× · PMID 37588660 · DOI 10.1515/med-2023-0768
5. Comparing the efficacy of regen-cov, remdesivir, and favipiravir in reducing invasive mechanical ventilation need in hospitalized COVID-19 patients.
   Hegazy SK, Tharwat S, Hassan AH. · · 2023 · cited 3× · PMID 37731581 · DOI 10.12998/wjcc.v11.i26.6105
6. Repurposing existing drugs for the treatment ofCOVID-19/SARS-CoV-2: A review of pharmacological effects and mechanism of action.
   Liang Y, Quan X, Gu R, Meng Z, et al · · 2024 · cited 2× · PMID 39247343 · DOI 10.1016/j.heliyon.2024.e35988
7. Clinical Study to Evaluate the Possible Efficacy and Safety of Antibodies Combination (casirivimab and imdevimab) versus standard antiviral therapy as antiviral agent against Corona virus 2 infection in hospitalized COVID-19 patients
   Hassan AH, Hegazy SK, Radwan ST. · · 2023 · DOI 10.21203/rs.3.rs-1991618/v2
8. Clinical Study to Evaluate the Possible Efficacy and Safety of Antibodies Combination (casirivimab and imdevimab) versus standard antiviral therapy as antiviral agent against Corona virus 2 infection in hospitalized COVID-19 patients
   Hassan AH, Hegazy SK, Radwan ST. · · 2022 · DOI 10.1101/2022.08.20.22279020