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Trial - NCT04738175


Column Value
Trial registration number NCT04738175
Full text link
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04738175

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. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-02-04

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

Withdrawn

Study design
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - outpatient with recent covid-19 diagnosis with mild or moderate symptoms lasting less than 7 days prior to screening and not requiring imminent hospitalization - no medical or psychiatric conditions that could put the subject at risk - willing to follow contraception guidelines

Exclusion criteria
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- clinical signs of covid-19 indicative of impending hospitalization - documented infection in addition to covid-19 that requires systemic treatment - medical condition that could adversely impact safety, in the investigator's opinion - is or planning to be pregnant or lactating - 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 - has received or will receive during study participation a vaccine for covid-19 - has participated in clinical trial protocols in the last 12 months, unless the investigator believes that there may be a direct benefit to the subject

Number of arms
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Sorrento Therapeutics, Inc.

Inclusion age min
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Feb. 6, 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. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Changes in viral shedding from Baseline to Day 15;Incidence of adverse events by type, frequency, severity, and causality (safety)

Notes
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

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

Phase 1/Phase 2

Arms
Last imported at : Feb. 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "40 mg", "treatment_id": 1242, "treatment_name": "Sti-2020", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"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"}]