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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Arm | Experimental | Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C |
|
| Placebo | Placebo Comparator | Placebo and Vitamin D3, Vitamin C, and Zinc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin | Drug | Treatment days 1, 4, and 8 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Non-Infectivity by RT-PCR | Time to negative RT-PRC result indicating that patient is no longer infective | 6 months |
| Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score) | Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk. | 6 months |
| Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score) | Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk. | 6 months |
| Efficacy of Treatment as measured by Titer | Patients will have serum stored for titer testing to compare antibody levels over time | 6 months |
| Efficacy of Treatment as measured by RT-PCR | Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Treatment as Measured by D-Dimer | Blood D-Dimer levels | 6 Months |
| Safety of Treatment as Measured by Pro-Calcitonin | Blood Pro-Calcitonin levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Hazan, MD | ProgenaBiome | Study Director |
| Thomas Borody, MD | Topelia Therpeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProgenaBiome | Ventura | California | 93003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39702045 | Derived | 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. | |
| 35135310 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 17, 2025 | |
| Reset | Jul 1, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2025 | Jul 1, 2025 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| D004318 | Doxycycline |
| D015032 | Zinc |
| D019287 | Zinc Sulfate |
| D002762 | Cholecalciferol |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Doxycycline Hcl | Drug | 10 day treatment |
|
|
| Zinc | Dietary Supplement | 10 Day treatment |
|
|
| Vitamin D3 | Dietary Supplement | 10 day treatment |
|
|
| Vitamin C | Dietary Supplement | 10 day treatment |
|
|
| 6 Months |
| Safety of Treatment as Measured by C-Reactive Protein | Blood CRP levels | 6 Months |
| Safety of Treatment as Measured by Ferritin | Blood ferritin levels | 6 Months |
| Safety of Treatment as Measured by Liver Enzymes | Blood enzyme levels | 6 Months |
| Safety of Treatment as Measured by Complete Blood Count | CBC | 6 Months |
| Safety of Treatment as Measured by Electrolyte Levels | Blood electrolytes | 6 Months |
| Safety of Treatment as Measured by Treatment Related Adverse Events | Presence or absence of Grade 3 or high treatment related adverse events | 6 months |
| 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. |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013754 |
| Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D017967 | Zinc Compounds |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |