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Trial - NCT04771351


Column Value
Trial registration number NCT04771351
Full text link
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04771351

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. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-02-25

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

Withdrawn

Study design
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

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

single-center

Study aim
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - positive for covid-19 by an approved antigen test - progressive disease suggestive of ongoing covid-19 infection - requires hospitalization for acute medical care - provides written informed consent - willing to follow contraception guidelines during study

Exclusion criteria
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- requires high-flow oxygen supplementation - current or imminent respiratory failure - has rapidly progressing symptoms that in the investigator's opinion are likely to progress to needing high-flow oxygen or to respiratory failure within 24 to 48 hours - any condition which, in the investigator's opinion, participation would not be in the subject's best interest or could prevent, limit, or confound the protocol-specified assessments - has participated, or is participating in, a clinical research study evaluating covid-19 convalescent plasma, monoclonal antibodies against sars-cov-2, or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer) - pregnant or lactating and breast feeding, or planning on either during the study - unable to comply with planned study procedures and be available for all follow-up visits

Number of arms
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Sorrento Therapeutics, Inc.

Inclusion age min
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : April 14, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe 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. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Proportion of subjects who are alive and free of respiratory failure at Day 29

Notes
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Feb. 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "100 mg", "treatment_id": 1242, "treatment_name": "Sti-2020", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "200 mg", "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"}]