COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12622000386730.aspx

Lucas McLindon

info@PACTrial.com.au

2022-03-04

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

• COVID-19 diagnosis in the preceding 4 days (RAT positive or PCR positive) • At least 40 years old

• Women who are pregnant, breastfeeding or actively trying to achieve a pregnancy • Current hospital inpatient with COVID-19 related disease • Allergy to ivermectin, doxycycline or famotidine • Known bleeding disorder • Known severe liver disease • Diagnosis of Myasthenia Gravis/SLE • Consumption of grapefruit juice • Ever travelled to countries that are endemic for Loa loa (West and Central Africa – Angola, Cameroon, Central African Republic, Democratic Republic of Congo, Ethiopia, Guinea, Gabon, Republic of Congo, Nigeria and Sudan) • Currently on the following medications: o Cardiac - quinidine, amiodarone, diltiazem, verapamil, warfarin o Anti-infective – clarithromycin, erythromycin, itraconazole, ketoconazole, o Anti-viral – indinavir, ritonavir, cobicistat o Disease modifying – cyclosporine, tacrolimus, sirolimus, methotrexate o Other – retinoids, lithium, spironlactone Neither minority groups nor NESB/LOTE persons will be excluded provided they possess the capacity (ie ability to understand, retain, comprehend and dutifully consider a response) to consent.

2

AProf Dr Karin Ried

40

100

Australia

Mild disease at enrollment

1: Mild disease at enrollment

300

The primary outcome of this trial is hospital admission.Hospital admission is defined as the requirement to receive inpatient care for a COVID-19 related illness.This can include short stay emergency department admission; hospital in the home (HITH) admission/care; general medical admission; intensive care admission.Assessed by data linkage to patient medical records[daily for 15 days since enrolment]

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 2404, "treatment_name": "Doxycycline+famotidine+ivermectin+vitamin c+vitamin d+zinc", "treatment_type": "Antibiotics+others pharmacological treatment+antiparasitics+vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2403, "treatment_name": "Doxycycline+ivermectin+vitamin c+vitamin d+zinc", "treatment_type": "Antibiotics+antiparasitics+vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}]