None listed
Conditions
Brief summary
The trial will recruit participants who have, in the preceding 72 hours, had close contact with a person infectious with SARS-CoV-2. Participants must have, since that contact, tested negative for SARS-CoV-2 on polymerase chain reaction (PCR) of pharyngeal swab or on a rapid antigen test (RAT) and be asymptomatic of: fever, new cough, sore throat, rhinorrhoea, loss of smell, loss of taste, or more difficulty breathing than usual. Participants will be randomized 1:1 to receive either Ivermectin 200ug/kg orally or Placebo on Day 1. The trial will recruit until 40 participants have converted to a positive PCR or TGA-approved RAT for SARS-CoV-2 within 14 days of their contact with an infectious SARS-CoV-2 index case. Amongst the 40 participants who convert to a positive PCR or positive TGA-approved RAT for SARS-CoV-2, the proportion who received Ivermectin. Specifically, the trial will test whether that proportion is less than half.
Interventions
Single dose of ivermectin 200ug/kg orally or matching placebo tablets. The trial will recruit participants who have, in the preceding 72 hours, had close contact with a person infectious with SARS-CoV-2. Participants must have, since that contact, tested negative for SARS-CoV-2 on a polymerase chain reaction (PCR) from a pharyngeal swab or on a rapid antigen test (RAT) and be asymptomatic of: fever, new cough, sore throat, rhinorrhoea, loss of smell, loss of taste, or more difficulty breathing t
Single dose of ivermectin 200ug/kg orally or matching placebo tablets. The trial will recruit participants who have, in the preceding 72 hours, had close contact with a person infectious with SARS-CoV-2. Participants must have, since that contact, tested negative for SARS-CoV-2 on a polymerase chain reaction (PCR) from a pharyngeal swab or on a rapid antigen test (RAT) and be asymptomatic of: fever, new cough, sore throat, rhinorrhoea, loss of smell, loss of taste, or more difficulty breathing than usual. The baseline PCR or RAT is required to determine qualification for the study but is not performed as part of the study. Participants will be randomized 1:1 to receive either Ivermectin 200ug/kg orally or Placebo tablets on Day 1. Approximately 4 hours after receipt of the study drug the participants will be contacted by staff from the CRO and asked whether all study tablets were taken and, if not, why not. The trial will recruit until 40 participants have converted to a positive pharyngeal swab PCR or positive TGA-approved RAT for SARS-CoV-2 within 14 days of their contact with an infectious SARS-CoV-2 index case.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. In the preceding 72 hours, had close contact with a person infectious with SARS-CoV-2. • AND that contact was in the context of i) a participant’s home or ii) an indoor work environment or iii) a family gathering or a social or a religious function or a ceremony each being of less than 30 people. • AND since that contact, tested negative for SARS-CoV-2 on polymerase chain reaction(PCR) of pharyngeal swab or on a rapid antigen test (RAT). • AND are asymptomatic of fever, new cough, sore throat, rhinorrhoea, loss of smell, loss of taste, or more difficulty breathing than usual.
Exclusion criteria
• Not agreeable to being at home for delivery of the investigational product •The close contact with an infectious index case of SARS-CoV-2 occurred in a hospital •Residing outside the current geographic recruitment area •The index case who has SARS-CoV-2 lives in the same residence as the potential participant. •Another person who lives in the same residence as the potential participant has returned a positive pharyngeal PCR or a RAT for SARS-CoV-2 in the last 2 weeks. •Unable to provide the name, address and phone number of the potential participant’s general practitioner/primary care physician OR does not have such a general practitioner/primary care physician. . Has not attended a doctor at the practice of the above general practitioner/primary care physician for more than 12 months. (NB Given the pandemic, that attendance may have been by telehealth). • Lives alone (as potentially at higher risk should there be a serious adverse event). • Unable to provide the name and phone number of a back-up contact person. • History of past infection with SARS-CoV-2. • Use of Ivermectin for any purpose in 5 weeks prior to enrolment. • Known past allergy or severe adverse reaction to Ivermectin. • Weight <45kg or > 120kg. • Pregnant or breast feeding. • Not willing to refrain from falling pregnant or fathering a child for 6 months after last dose of investigational product. • Cirrhosis or known decompensated liver disease (Child-Pugh B or C). • Current use, or use within the last 3 months, of the drug amiodarone. • Current use of any of the following drugs: warfarin, verapamil, diltiazem, quinidine, spironolactone, ciclosporin, tacrolimus, cobicistat, indinavir, ritonavir, didanosine (DDI), ketoconazole, itraconazole, fusidic acid, erythromycin, clarithromycin. • Past sedation or somnolence from products containing codeine • History of residency or travel to loa loa endemic areas (“Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan”, Chaccour et al 2020b). • Severe Asthma • Encephalopathy. . Head injury requiring medical attention in the last 6 months. . Concussion within the last 6 months. • Fit, seizure, stroke, TIA (transient ischaemic attack) or transient global amnesia in the last 6 months. • History of epilepsy (as Stromectol product information notes in “Post-marketing Experience” “very rarely,…seizures”). • Dementia of any type. • Not usually fully independent in activities of daily living and self-care, including: washing, toileting, dressing and dental care. • Inability of participant to communicate to the level necessary to provide verbal or written consent. • Incarcerated by local, state or federal authorities. • Conditions which in the opinion of the investigative team would make successful trial completion (including follow up data collection) unlikely, for example including uncontrolled substance use, poorly controlled mental state disorder. • Unable to advise trial staff of Coronavirus vaccination status including date of administration of last vaccine dose. . Already enrolled in another Coronavirus RCT • In Australia, lack of a valid Medicare Card • Unable or unwilling to have a RAT upon receipt of investigational product and on days 1, 2, 3, 4, 5, and on days 6 and 14 following close contact. • Unable or unwilling to have a pharyngeal swab PCR test for SARS-CoV-2 at 6 and/or 14 days post initial exposure to a close contact if such tests are then practical and available given the then public health circumstances.
Outcome results
None listed