COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05224856

Not reported

Not reported

2022-02-04

Withdrawn

RCT

Randomized

Parallel

Blind label

unclear

Treatment

inclusion criteria: 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.

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.

2

Celltrion

18

100

None

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

0

Time to clinical recovery

None

Phase 3

[{"arm_notes": "Inhalation", "treatment_id": 2157, "treatment_name": "Ct-p63+ct-p66", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]