In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.
Patients in this trial will undergo treatment for 10 days with either a combination of
therapies or placebo. They will then be followed for an additional 20 days.
Drug: Ivermectin
Treatment days 1, 4, and 8
Other Name: Soolantra, Stromectol, Sklice
Drug: Doxycycline Hcl
10 day treatment
Other Name: Doxy-100, Monodox, Oracea, Targadox, Acticlate, Morgidox, Avidoxy, Doryx MPC, Mondoxyne NL, Dory
Dietary Supplement: Zinc
10 Day treatment
Other Name: Zinc sulphate
Dietary Supplement: Vitamin D3
10 day treatment
Other Name: cholecalciferol-D3
Dietary Supplement: Vitamin C
10 day treatment
Other Name: L-ascorbic acid
Inclusion Criteria:
1. Signed informed consent, demonstrating that the subject understands the procedures
required for the study and the purpose of the study
2. Healthy male or female subjects at least 18 years of age
3. Diabetic and obese (BMI > 30) patients will be included in the Trial but randomization
will be stratified.
4. Positive test for COVID-19 by RT-PCR or rapid antigen test at screening
5. Subjects must agree to practice at least two highly effective methods of birth control
for the duration of the study. One of these must be a barrier method. Exceptions for
females and partners of females that are not of childbearing potential. (e.g.
surgically sterilized, post-menopausal)
6. Subjects must agree they will attend the treatment facility daily for 10d in the event
of failure to attend, the patient will be visited at their home to collect the nasal
swab and review data.
Exclusion Criteria:
1. Refusal to sign informed consent form
2. Negative test for COVID-19 by RT-PCR at screening
3. Severe disease symptomatically including pneumonia, respiratory distress, tachypnea,
shortness of breath, temperature > 104.0 degrees F, pleuritic pain, or frequent cough.
4. Known drug allergy to any of the investigational medications
5. Currently taking medication with known drug interactions with investigational
medications, found in Appendix II
6. Prescription or other antiviral medications
7. Any comorbidities which constitute health risk for the subject including known cardiac
arrhythmias - but will be limited to those on hydroxychloroquine
8. Inability to attend daily for 10 days
ProgenaBiome
Ventura, California, United States