COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05074394

Mike Royal, MD

mroyal@sorrentotherapeutics.com

2021-10-12

Withdrawn

RCT

Randomized

Parallel

Blind label

unclear

Treatment

inclusion criteria: - positive for covid-19 with any approved rt-pcr or rapid antigen test within 7 days of planned treatment - have mild illness/symptoms based upon nih criteria. the nih illness severity definition for "mild" states as follows: "individuals who have any of the various signs and symptoms of covid-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging." - be in good health as judged by investigator using screening medical history and physical examination. participants who are otherwise healthy with a stable chronic medical condition may enroll - a prior covid-19 infection in the past from which the subject fully recovered or a previously unknown asymptomatic infection is allowed, as is any previous covid-19 vaccination - 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 the protocol - subject must have provided written informed consent which includes signing the institutional review board or independent ethics committee approved consent form prior to participating in any study related activity - willing to follow contraception guidelines

- in the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours) - currently using chronic oxygen therapy due to an underlying comorbidity and requires an increase in baseline oxygen flow rate due to covid-19 infection - is an immunocompromised subject even if previously fully vaccinated against covid-19 or recovered from a prior covid-19 infection - has an active documented infection other than covid-19 - any medical condition that, in the investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process - pregnant or lactating women who are breast feeding or planning on either during the study - has received within the 30 days prior to screening or is planning on receiving an eua-cleared monoclonal antibody (mab) during the study - has participated or is participating in a clinical research study evaluating covid-19 convalescent plasma, other non-eua-cleared mabs against covid-19 or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit

2

Sorrento Therapeutics, Inc.

18

100

None

Mild disease at enrollment

1: Mild disease at enrollment

0

Proportion of subjects who have a COVID-19-related visit or hospitalization

None

Phase 2

[{"arm_notes": "", "treatment_id": 1243, "treatment_name": "Sti-2099", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]