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| Column | Value |
|---|---|
| Trial registration number | NCT05372783 |
|
Full text link
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Aug. 19, 2022, 7:30 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Aug. 19, 2022, 7:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
2022-05-13 |
|
Recruitment status
Last imported at : Feb. 14, 2023, noon Source : ClinicalTrials.gov |
Withdrawn |
|
Study design
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : May 14, 2022, 7 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 : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
inclusion criteria: otherwise healthy, positive for covid-19 by an eua-approved rapid antigen or pcr test, has ongoing "mild to moderate illness or symptoms" with symptom onset starting < 5 days prior to screening visits must provide written informed consent/assent if a minor which includes signing the institutional review board/independent ethics committee approved consent form prior to participating in any study related activity willing and able to comply with study procedures and follow-up visits willing to follow all contraception guidelines |
|
Exclusion criteria
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
in the investigator's opinion, has progressive symptoms with likely imminent (24-48 hours) hospitalization or severe covid-19 illness/symptoms any medical condition that, in the investigator's or designee's opinion, could adversely impact participant safety or key objectives of the study has a prior history of long covid has a clinically documents acute infection other than covid-19 known or suspected pregnancy, planned pregnancy, a positive pregnancy test at screening or are breastfeeding has participated, or is participating in a clinical reserach study evaluating covid-19 convalescent plasma, mabs against sars-cov-2, or iv immunoglobulin within 2 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 : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Sorrento Therapeutics, Inc. |
|
Inclusion age min
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
12 |
|
Inclusion age max
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Aug. 19, 2022, 7:30 p.m. Source : ClinicalTrials.gov |
United States |
|
Type of patients
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
|
Severity scale
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
|
Total sample size
Last imported at : Feb. 14, 2023, noon Source : ClinicalTrials.gov |
0 |
|
primary outcome
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Change in viral load;Incidence of adverse events (AEs) (safety) |
|
Notes
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 2480, "treatment_name": "Sti-9199", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |