None listed
Conditions
Brief summary
COVID-19 is a global pandemic and has limited cost-effective early treatments. There is some evidence that the use of Vitamin C, Vitamin D and Zinc may be of benefit in conjunction with Ivermectin and Doxycycline. The second phase of the illness is inflammatory and it is possible that Famotidine may help this phase and reduce people needing hospitalisation. This randomised multi-centre outpatient trial aims to ascertain whether therapy with Ivermectin, Doxycycline, Vitamin C, Vitamin D, and Zinc with or without Famotidine reduces hospitalisation.
Interventions
2 trial arms:
1) Ivermectin, Doxycycline, Vitamin C, Vitamin D3 and Zinc
2) Ivermectin, Doxycycline, Vitamin C, Vitamin D3 and Zinc plus Famotidine
with the following daily doses for 10 days:
Arm 1+2:
Ivermectin 12 mg twice daily
Doxycycline 100mg twice daily
Vitamin C (1 gm thrice daily)
Vitamin D3 (10,000iu midday daily)
Zinc picolinate (50 mg elemental midday daily)
plus - Arm 2 only:
Famotidine (Histamine H2 receptor antagonist) 40mg twice daily for 10 days
Therapy packs are dispensed as
2 trial arms: 1) Ivermectin, Doxycycline, Vitamin C, Vitamin D3 and Zinc 2) Ivermectin, Doxycycline, Vitamin C, Vitamin D3 and Zinc plus Famotidine with the following daily doses for 10 days: Arm 1+2: Ivermectin 12 mg twice daily Doxycycline 100mg twice daily Vitamin C (1 gm thrice daily) Vitamin D3 (10,000iu midday daily) Zinc picolinate (50 mg elemental midday daily) plus - Arm 2 only: Famotidine (Histamine H2 receptor antagonist) 40mg twice daily for 10 days Therapy packs are dispensed as ten days supply (at daily dosing), to be administered as one tablet and one capsule three times daily for ten days. Arm 1: Core Therapy - 20 capsules containing (ivermectin 12mg, doxycycline 100mg), vitamin-C 1g (30 tablets), 10 capsules containing (vitamin D3 10000iu, zinc picolinate 50mg). Arm 2: Core Therapy & Famotidine - 20 capsules containing (ivermectin 12mg, doxycycline 100mg, famotidine 40mg), vitamin-C 1g (30 tablets), 10 capsules containing (vitamin D3 10000iu, zinc picolinate 50mg). The morning and evening therapy (containing ivermectin) is to be consumed with a fatty meal prepared by the participant's at their own discretion. Both intervention and control groups will be able to make contact with the Trial Research Nurse at any time. Compliance will be checked daily by verbal confirmation with the trial nurse.
Sponsors
AProf Dr Karin Ried
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• COVID-19 diagnosis in the preceding 4 days (RAT positive or PCR positive) • At least 40 years old
Exclusion criteria
• 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.
Outcome results
None listed