Trial of Combination Therapy to Treat COVID-19 Infection
NCT ID: NCT04482686
Last Updated: 2024-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2020-12-09
2022-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active Arm
Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C
Ivermectin
Treatment days 1, 4, and 8
Doxycycline Hcl
10 day treatment
Zinc
10 Day treatment
Vitamin D3
10 day treatment
Vitamin C
10 day treatment
Placebo
Placebo and Vitamin D3, Vitamin C, and Zinc
Zinc
10 Day treatment
Vitamin D3
10 day treatment
Vitamin C
10 day treatment
Interventions
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Ivermectin
Treatment days 1, 4, and 8
Doxycycline Hcl
10 day treatment
Zinc
10 Day treatment
Vitamin D3
10 day treatment
Vitamin C
10 day treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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ProgenaBiome
OTHER
Responsible Party
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Principal Investigators
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Sabine Hazan, MD
Role: STUDY_DIRECTOR
ProgenaBiome
Thomas Borody, MD
Role: STUDY_DIRECTOR
Topelia Therpeutics
Locations
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ProgenaBiome
Ventura, California, United States
Countries
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References
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Hazan S, Vidal AC, Hulscher N, Goudzwaard A, McCullough PA, Steinberg AA. Cardiac findings in a phase II double-blind randomized placebo-controlled trial of combination therapy (HAZDPac) to treat COVID-19 patients. BMC Cardiovasc Disord. 2024 Dec 19;24(1):710. doi: 10.1186/s12872-024-04376-y.
Hazan S, Dave S, Gunaratne AW, Dolai S, Clancy RL, McCullough PA, Borody TJ. Effectiveness of ivermectin-based multidrug therapy in severely hypoxic, ambulatory COVID-19 patients. Future Microbiol. 2022 Mar;17:339-350. doi: 10.2217/fmb-2022-0014. Epub 2022 Feb 9.
Other Identifiers
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PRG-049
Identifier Type: -
Identifier Source: org_study_id
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