To Evaluate the Safety and Efficacy of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With COVID-19 Not Requiring Supplemental Oxygen

NCT05224856 | Withdrawn Phase 3

• 1 other identifier: CT-P63/66 3.1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase 3 study to assess the efficacy about therapeutic effect of inhaled CT-P63 and CT-P66 combination therapy to symptomatic patiemts with COVID-19 and overall safety.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Time to clinical recovery

  To evaluate the therapeutic efficacy of CT-P63 and CT-P66 combination therapy as of clinical recovery of the patients' COVID-19 symptoms.

  Up to Day 14

Secondary Outcomes (1)

• Overall safety

  Up to Day 90

Study Arms (2)

CT-P63 and CT-P66

EXPERIMENTAL

Biological: CT-P63 and CT-P66 / Placebo

Placebo

PLACEBO COMPARATOR

Biological: CT-P63 and CT-P66 / Placebo

Interventions

CT-P63 and CT-P66 / Placebo BIOLOGICAL

Inhalation

CT-P63 and CT-P66; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female patient, aged 18 or above.
• Patient diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR.
• Patient with conditions meeting all of the following criteria:
• Oxygen saturation ≥ 94% on room air.
• Not requiring supplemental oxygen.
• Patient who has onset of one or more of the SARS-CoV-2 infection associated symptoms within 7 days prior to the study drug administration.

You may not qualify if:

• Patient with current serious condition meeting one of the following:
• Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions.
• Respiratory distress with respiratory rate ≥30 breaths/min.
• Severe pneumonia
• Requires supplemental oxygen
• Experience shock
• Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
• Patient who has received or has a plan to receive any of following prohibited medications or treatments:
• Drugs with actual or possible antiviral drugs and/or possible anti-SARS-CoV-2 activity including but not limited to nirmatrelvir and ritonavir, molnupiravir, remdesivir, chloroquine, hydroxychloroquine, dexamethasone (or alternative corticosteroids to dexamethasone), and other immunomodulatory agents and human immunodeficiency virus protease inhibitors for therapeutic purpose of SARS-CoV-2 infection prior to study drug administration
• Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of COVID-19 infection prior to study drug administration
• Any approved monoclonal antibody (sotrovimab, casirivimab and imdevimab, bamlanivimab and etesevimab, etc), any other investigational device or medical product including but not limited to any monoclonal antibody(tocilizumab, sarilumab, etc.), fusion proteins or biologics for the treatment of COVID-19 infection prior to the first study drug administration.
• Any investigational vaccine for SARS-CoV-2.

Sponsors & Collaborators

• Celltrion: lead

MeSH Terms

Conditions

COVID-19

Interventions

CT-P63; CT-P66

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 4, 2022
• Study Start: April 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: January 1, 2023
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share