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Unable to recruit participants due to restrictive inclusion/exclusion criteria. Will update protocol with IRB & begin anew after approval.
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Study into the effects of daily use of metformin and low-dose naltrexone (LDN) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19.
The researchers will treat 40 patients with metformin (1500 mg/day) and LDN (4.5 mg/day) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19. These 40 patients will be compared with 40 control patients who will receive regular care. All patients will be asked to complete surveys at baseline and after 1, 2, and 4 weeks after initiation of treatment. The difference with baseline at each time point will be assessed. The surveys will assess COVID-19 symptoms severity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Metformin and LDN | Experimental | Patients will be treated with 1500 mg/day of metformin and 4.5 mg/day of LDN for a total of 4 weeks. |
|
| Regular health care comparison group | No Intervention | Patients will receive regular health care and will serve as a control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin at 1500 mg/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of COVID-19 symptoms after 1 week of treatment with metformin and LDN | Reduction in COVID-19 symptoms as measured with the COVID-19 Symptoms Severity Scale. The scale has a minimum score of 0 and a maximum of 24, with values ranging from 4-11 are considered 'mild symptoms', scores ranging 12-19 are considered 'moderate', and scores 20-24 are considered 'severe'. | 1 week |
| Reduction of COVID-19 symptoms after 2 weeks of treatment with metformin and LDN | Reduction in COVID-19 symptoms as measured with the COVID-19 Symptoms Severity Scale. The scale has a minimum score of 0 and a maximum of 24, with values ranging from 4-11 are considered 'mild symptoms', scores ranging 12-19 are considered 'moderate', and scores 20-24 are considered 'severe'. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in recovery time from COVID-19 | Reduction in the number of days with symptoms due to COVID-19 upon treatment with metformin and LDN, compared to placebo group | 4 weeks |
| Reduction in hospitalizations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sajad Zalzala, MD | AgelessRx | Study Director |
| Sajad Zalzala, MD | AgelessRx | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AgelessRx | Ann Arbor | Michigan | 48104 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D009270 |
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| Naltrexone |
| Drug |
Naltrexone at 4.5 mg/day (LDN) |
|
|
Reduction in the number of patients being hospitalized due to COVID-19 upon treatment with metformin and LDN, compared to placebo group
| 4 weeks |
| Reduction in requirement of additional treatment due to COVID-19 | Reduction in the number of patients requiring additional treatment for COVID-19 upon treatment with metformin and LDN, compared to placebo group | 4 weeks |
| Reduction in mortality | Reduction in the number of mortality cases due to COVID-19 upon treatment with metformin and LDN, compared to placebo group | 4 weeks |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |