Status and phase
Conditions
Treatments
About
This exploratory study is a randomized, single center, open label study of four different experimental treatment arms versus standard of care for the treatment of SARS-CoV-2 infection in symptomatic outpatients with mild disease at the time of enrollment.
Full description
This phase 2, exploratory study will be an adaptive, randomized, open label, trial for treatment of individuals in an outpatient settings with mild SARS-CoV-2 infection. The primary outcome is focused on the evaluation of efficacy of the proposed experimental drugs in reducing upper respiratory viral shedding, defined as viral clearance (i.e., negative swab) on Day 7. Key secondary outcomes focus on other measures of viral shedding, safety evaluation, progression to LRTI (defined by resting blood oxygen saturation level [SpO2] <93% sustained for two readings two hours apart and presence of subjective dyspnoea or cough), disease severity, clinical resolution rate, and cumulative incidence of hospitalization or mortality at Day 28.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Pregnant or lactating women.
Known hypersensitivity or specific contraindications to the use of any of the active drugs in the treatment arms, or similar compounds.
Signs of respiratory distress prior to randomization, including:
Resting pulse rate ≥120 beats/min.
High likelihood of hospitalization in the opinion of the attending clinician.
QTcF >470 msec for females, or >450 msec for males, at screening.
Serum potassium <3.5 mmol/L at screening.
History of clinically significant cardiovascular disease (including arrhythmias, QT-interval prolongation, torsades de pointes (TdP), history of coronary artery disease with graft or stent procedures/surgery, cardiac failure [class 2 or higher using the New York Heart Association functional classification]).
Known chronic kidney disease (Stage IV or receiving dialysis).
Known cirrhosis (Child-Pugh Class B or greater).
Known macular degeneration, or other known retinal diseases, or 4-aminoquinolone-induced visual impairment.
Currently receiving, or recently received (within 60 days prior to randomization) treatment with any of the drugs in the treatment arms.
Currently receiving, or recently received (within 30 days prior to randomization) treatment with any antimalarial drugs.
Currently on treatment with drugs with known arrhythmogenic potential, or those known to induce significant QT-interval prolongation or TdP, as detailed in Appendix 6.
Currently on treatment for tuberculosis (or on treatment with rifampicin for any other indication), or on treatment with a protease inhibitor-based antiretroviral regimen, or efavirenz, or carbamazepine.
Inability/unlikely to be in the study area for the duration of the 28 day follow-up period.
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the volunteer or the objectives of the study. The Investigator should make this determination in consideration of the volunteer's medical history.
Personnel (e.g. investigator, sub-investigator, research assistant, pharmacist, study coordinator or anyone mentioned in the delegation log) directly involved in the conduct of the study.
Participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results.
Primary purpose
Allocation
Interventional model
Masking
192 participants in 5 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal