COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT04317040


Column Value
Trial registration number NCT04317040
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04317040

First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Shyamasundaran Kottilil

Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Pan Zheng, pzheng@oncoimmune.com (PI email not reported)

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-03-20

Recruitment status
Last imported at : Feb. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - diagnosed with coronavirus disease 2019 (covid-19) and confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) viral infection - severe or critical covid-19, or national institute of allergy and infectious diseases (niaid) 8-point ordinal score 2, 3 or 4 (scale 2: requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ecmo); scale 3: non-invasive ventilation or high flow oxygen devices; scale 4: supplemental oxygen support; a peripheral capillary oxygen saturation (spo2) </= 94% or tachypnea (respiratory rate >/= 24 breaths/min). intubation should be within 7 days

Exclusion criteria
Last imported at : Feb. 13, 2023, 8:44 a.m.
Source : ClinicalTrials.gov

participants who are pregnant, breastfeeding, or have a positive pregnancy test result before enrollment participants previously enrolled in the efprezimod alfa study intubation for invasive mechanical ventilation is over 7 days documented acute renal or hepatic failure the investigator believes that participating in the trial is not in the best interests of the participant, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues)

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Dec. 11, 2023, midnight
Source : ClinicalTrials.gov

Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

234

primary outcome
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Number of Participants Who Experience an Adverse Event (AE);Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Feb. 13, 2023, 8:44 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 259, "treatment_name": "Cd24fc", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]