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Trial - NCT04734860


Column Value
Trial registration number NCT04734860
Full text link
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04734860

First author
Last imported at : Feb. 26, 2022, 7 p.m.
Source : ClinicalTrials.gov

Mike Royal, MD

Contact
Last imported at : Feb. 26, 2022, 7 p.m.
Source : ClinicalTrials.gov

mroyal@sorrentotherapeutics.com

Registration date
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-02-02

Recruitment status
Last imported at : Feb. 26, 2022, 7 p.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - positive for covid-19 by an approved antigen test - mild symptoms consistent with a covid-19 viral infection - willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol - willing to follow contraception guidelines

Exclusion criteria
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- evidence of moderate covid-19 per fda severity categorization - pregnant or lactating and breast feeding or planning on either during the study - has a documented infection other than covid-19 - has received a covid-19 vaccine - has participated, or is participating, in a clinical research study evaluating covid-19 convalescent plasma, monoclonal antibodies (mabs) against sars-cov-2, or intravenous immunoglobulin (ivig) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit

Number of arms
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Sorrento Therapeutics, Inc.

Inclusion age min
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : April 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : Feb. 26, 2022, 7 p.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Proportion of subjects who have remained out of the hospital or emergency room through Day 29

Notes
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

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

Phase 2

Arms
Last imported at : Feb. 4, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1242, "treatment_name": "Sti-2020", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]