COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04584697

Mike Royal, MD

mroyal@sorrentotherapeutics.com

2020-10-14

Withdrawn

RCT

Randomized

Sequential assignment

Blind label

multi-center

Treatment

inclusion criteria: - must be covid-19 positive by rt-pcr or an equivalent test, using an appropriate sample such as nasopharyngeal [np], nasal, oropharyngeal [op], or salivary) ≤ 72 hours prior to randomization. a historical record of positive result from test conducted ≤ 72 hours prior to randomization is acceptable if it can be documented. - must be asymptomatic or have mild symptoms but not requiring imminent (within 24h) hospitalization. - must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by this protocol. - subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity.

- have a documented infection other than covid-19 that requires systemic treatment or in the investigator's opinion could interfere with the participant's safety or interfere with the assessments if enrolled in the study. - have any medical condition that, in the investigator's opinion, could adversely impact safety. - be pregnant or lactating and breast feeding - 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. note: subjects who have been prescribed hydroxychloroquine or chloroquine with or without azithromycin or other approved products for the off-label treatment of covid-19 prior to study enrollment may be included and may continue to receive these agents so long as the dose remains stable. additionally, any approved or authorized treatment (e.g., remdesivir, dexamethasone or treatments approved under an emergency use authorization) is allowed.

4

Sorrento Therapeutics, Inc.

18

100

None

Mild disease at enrollment

1: Mild disease at enrollment

0

Incidence of clinically meaningful laboratory abnormalities (safety);Incidence of treatment-emergent adverse events by type, frequency, severity, and causality (safety);Incidence of serious adverse events by type, frequency, severity, and causality (safety);Time from onset of COVID-19 symptoms to treatment (Day 1);Presence and levels of anti-drug antibodies directed to COVI-AMG;Viral load as assessed using plasma and salivary samples at various timepoints;Incidence of dose-limiting toxicities (safety);Cytokine levels post-treatment;Incidence of adverse events by type, frequency, severity, and causality (safety)

None

Phase 1/Phase 2

[{"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"}]