Covid-19 Living Data

Trial NCT04602000, EudraCT: 2020-003369-20
Publication Streinu-Cercel A, Open Forum Infect Dis (2022) (published paper)
Dates: 2020-10-07 to 2020-11-20
Funding: Mixed (Celltrion, Inc; Korea Health Industry Development Institute (KHIDI); Ministry of Health & Welfare, Republic of Korea; Medical writing support was funded by 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 ≥18 years oxygen saturation of >94% on room air and did not require supplemental oxygen onset of symptoms (feverishness, cough, shortness of breath, sore throat, body/muscle pain, fatigue, headache, chills, nasal congestion, loss of taste/smell, or diarrhea) was required to be within 7 days before study drug administration patients were required to present with fever, cough, shortness of breath, sore throat, body pain, fatigue, or headache within 48 hours before study drug administration.
Exclusion criteria	Current serious health condition ongoing or history of active or severe infections.
Interventions
	Treatment CT-P59 80mg/kg 80 mg/kg once-off via intravenous infusion over 90 ± 15 minutes CT-P59 40 mg/kg once-off via intravenous infusion over 90 ± 15 minutes
	Control Placebo
Participants
	Randomized participants : CT-P59 80mg/kg=111 CT-P59 =105 Placebo=111
	Characteristics of participants N= 327 Mean age : NR 166 males Severity : Mild: n= 327/ Asymptomatic: n=0 Number of vaccinated participants: 0
Primary outcome
	In the register 1) Proportion of patients with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit for Part 1 (Phase II) [ Time Frame: Up to Day 14 ]; 2) Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit for Part 1 (Phase II) [ Time Frame: Up to Day 14 ] 3) Time to clinical recovery for Part 1 (Phase II) [ Time Frame: Up to Day 14 ] 4) Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection for Part 1 (Phase II) [ Time Frame: Up to Day 28 ]
	In the report 1)Time to conversion to negative nasopharyngeal swab specimen based on RT-qPCR (negative titer threshold of 2.33 log10 copies/mL) up to day 28; 2)Time to clinical recovery up to day 14.
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: N
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	Some concerns
General comment	“In addition to the published article, the supplementary appendix and two study registries were used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. The primary outcomes in the article (time to negative conversion to day 28 and time to clinical recovery to day 14) differed slightly from those in the registries (proportion with negative conversion and time to negative conversion to day 14, time to clinical recovery to day 14 and proportion requiring hospitalization, oxygen or experiencing mortality to day 28). The study (n=327) achieved the target sample size (n=300) calculated in the supplementary appendix."