Trial NCT04602000; EudraCT: 2020-003369-20; CRIS: KCT000
Publication Eom J, 2021 (preprint)
Dates: 10/7/2020 to 11/20/2020
Funding: Private (Celltrion, Inc.)
Conflict of interest: Yes
Methods | |
RCT Blinding: triple blinding | |
Location :
Multicenter / South Korea, Romania, Spain, USA Follow-up duration (days): 28 | |
Inclusion criteria | Outpatients; Aged â¥18 years; diagnosed with SARS-CoV-2 infection at the study centers at screening using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or locally conducted reverse transcription polymerase chain reaction (RT-PCR); oxygen saturation of >94% on room air; did not require supplemental oxygen; symptom onset (feverishness, cough, shortness of breath, sore throat, body/muscle pain, fatigue, headache, chills, nasal congestion, loss of taste or smell, or diarrhea) within 7 days before study drug administration. |
Exclusion criteria | Current serious health condition or with ongoing or history of active or severe infections. |
Interventions | |
Treatment 1 CT-P59 40mg/kg | |
Control Placebo | |
Control CT-P59 80mg/kg | |
Participants | |
Randomized 327 participants n1=105/ n2=111/ n3=111 | |
Characteristics of participants N=327 Mean age : NR 166 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register Proportion of patient with negative conversion in nasopharyngeal swab specimen based on reverse transcription quantitative polymerase chain reaction(RT-qPCR)or cell culture at each visit. Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture. Time to clinical recovery. [ Time Frame: Up to Day 14 ] Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection. [ Time Frame: Up to Day 28 ] | |
In the report Time to conversion to negative nasopharyngeal swab specimen based on RT-qPCR (negative titer threshold: 2.33 log10 copies/ml) up to day 28 and time to clinical recovery up to day 14 | |
Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated No |
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Low |
General comment | In addition to the pre-print article, the study protocol, statistical analysis plan, three trial registries and supplementary materials were used in data extraction and assessment of risk of bias. There were no major differences between the pre-print article and the study protocol, statistical analysis plan and trial registry. The primary outcome indicated in the registry reflects the primary outcome reported in the paper. The pre-print reports on the first part of the study, enrolling around 300 participants. The study authors report that the second part of the study will enroll more participants and report on longer duration of follow-up. Consequently, the target sample size specified in the trial registry was not yet achieved and some outcomes/timepoints from the registry and protocol are not reported in the paper. |