Trial of Combination Therapy to Treat COVID-19 Infection

ProgenaBiome

Status and phase: Completed; Phase 1

Conditions: Corona Virus Infection; COVID; SARS-CoV Infection; SARS-CoV2; Coronavirus-19; Covid-19; Coronavirus Infection

Treatments: Dietary Supplement: Vitamin D3; Drug: Ivermectin; Drug: Doxycycline Hcl; Dietary Supplement: Zinc; Dietary Supplement: Vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT04482686

PRG-049

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups, including a placebo group

Active Arm

Experimental group

Description:

Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C

Treatment:

Dietary Supplement: Vitamin C

Dietary Supplement: Zinc

Drug: Doxycycline Hcl

Dietary Supplement: Vitamin D3

Drug: Ivermectin

Placebo

Placebo Comparator group

Description:

Placebo and Vitamin D3, Vitamin C, and Zinc

Treatment:

Dietary Supplement: Vitamin C

Dietary Supplement: Zinc

Dietary Supplement: Vitamin D3