Clinical Trial to Evaluate the Safety of RQ-01 in SARS-CoV-2 Positive Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

September 27, 2023

Primary Completion Date

January 3, 2024

Study Completion Date

January 3, 2024

Conditions
COVID-19Infectious DiseaseSymptomatic COVID-19 Infection Laboratory-ConfirmedSARS CoV 2 Infection
Interventions
COMBINATION_PRODUCT

RQ-001

"Drug product RQ-001 is the fully assembled device consisting of the vial containing RQ-01 and the actuator. Drug Product RQ-001 has been developed with an Aptar Bidose liquid nasal spray unit device (BDSI V3) capable of intranasally delivering a 200 uL total volume of drug product (specifically, 100 uL per nare, which delivers a 200 uL of total volume). The combination product comprises the drug constituent (RQ-01) and the assembly of commercially available, off-the-shelf device components.~Study staff will be responsible for assembling the drug product RQ-001 and subjects will self-administer under the supervision of study staff in the clinic."

OTHER

Placebo

Matching placebo will be manufactured just as RQ-01 drug substance, with the active ingredient addition step omitted. Placebo will appear similar to RQ-01 drug substance as a clear to hazy, colorless to yellowish liquid. Matching placebo will be administered the same way as RQ-01

Trial Locations (6)

21201

University of Maryland School of Medicine, Baltimore

33134

Florida International Medical Research, Miami

75230

Zenos Clinical Research, Dallas

77017

Vilo Research Group, L.L.C., Houston

90057

LA Universal Research Center, Inc., Los Angeles

98034

Evergreen Hospital Medical Center, Kirkland

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

lead

Red Queen Therapeutics, Inc.

INDUSTRY